Download Letter to John Oliver - LASIK Complications, Risks

Dear John,
First, let me begin by saying that I sincerely believe that you and your team have assembled the best show on
television. Your 10 to 13 minute segments offer perspective often not provided by the major networks. Your
show has a unique creative freedom, including free rein to criticize corporations. This brings me to why I write
to you today. Behind the image of Lasik as a miracle surgery, there are other, darker truths that are not well
known, but which are essential to recognize if the public health is to be protected.
Lasik patient advocacy; I am a director of Vision Surgery Complications, Inc. (VSC)—formerly known as Lasik
Surgery Watch, Inc. (LSW)—a non-profit LASIK patient advocacy organization. I am also part of a Facebook
group called Lasik Complications, which was started less than a year ago. The group has already grown to over
1,600 members. Stories of new members injured by Lasik on a daily basis are heartbreaking but all too
familiar.
There’s a good reason why eye doctors stick with their glasses; if LASIK were truly the miracle surgery that’s
portrayed in the advertisements, wouldn’t eye doctors have it? In fact, most eye doctors avoid LASIK. Lasik
surgeon and longtime FDA-advisor, Dr. Jayne Weiss, said at an FDA hearing on LASIK, “I would not tolerate any
risk for myself.” Perhaps if Dr. Weiss’ patients knew what she knows, very few would undergo the surgery.
Even the so-called inventor of Lasik, Dr. Gholam Peyman, wears glasses!
Lasik is a surgery for the uninformed public and not for the informed ophthalmologists. People’s lives are being
ruined by Lasik, and Lasik surgeons wearing glasses continue to insist that Lasik is “safe and effective”.
Lasik surgeons claim that they get Lasik done at “four times the penetration rate of the general population”
but this is based on an annual survey conducted by the American Society of Cataract and Refractive Surgeons
(ASCRS). ASCRS surveys their membership of 5000+ U.S. members. Only about 400 members respond. Of the
respondents, about 100 members state they had Lasik or some other form of corrective eye surgery. The Lasik
surgeons then publicize that 27% of their membership gets corrective eye surgery. Note that the survey data
could also present false information since it is always in the Lasik surgeon’s best interest to claim they had
refractive surgery to skew the survey results. Also, while some did have refractive surgery in the early days of
refractive surgery twenty years ago, it’s uncommon for an eye doctor to get Lasik today based on all of the
risks that are now common knowledge to those that are “in the know”.
In the end, look around. There are a lot of eye doctors wearing glasses. As a patient advocate, it becomes
common knowledge that many Lasik surgeons will wear their glasses on most days but switch to contact lenses
on their Lasik clinic days.
The following quote is from Drs. Marguerite McDonald and Richard Lindstrom. Both are renowned
ophthalmologists. Dr. McDonald was the first female president of both the American Society of Cataract and
Refractive Surgeons (ASCRS) and the International Society of Refractive Surgery (ISRS). Dr. Lindstrom also
served as president of ASCRS.
"While it may be ideal for a LASIK coordinator to have undergone LASIK, Drs. Lindstrom and McDonald agree
that it is not imperative. It is crucial, however, for the LASIK coordinator to never wear glasses while at work.
“They can wear contacts, but they can’t wear glasses. If they wear glasses, all the explaining in the world about
why they are not candidates for LASIK is not going to make a difference,” Dr. McDonald says."
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Former FDA Official Says FDA "Screwed Up" In Approving LASIK; Morris Waxler, Ph.D. was FDA’s former
Center for Drug Evaluation and Research (CDER) branch chief (i.e. chief scientist in charge of the clinical trials
research for LASIK in the 1990’s). After retiring from the agency, Dr. Waxler became a whistleblower in 2009
after hearing reports of widespread problems with LASIK. Dr. Waxler conducted his own, independent review
of Lasik safety. He admits that the agency made a mistake in approving LASIK under enormous pressure from
Lasik industry representatives working hand-in-glove with FDA reviewers. Dr. Waxler filed a petition with the
FDA in 2011 calling for an end to Lasik, an issuance of a LASIK public health advisory, and a criminal
investigation, saying, in part:
“LASIK manufacturers and their collaborators withheld safety and effectiveness information from their
investigational device exemption (IDE) reports to the FDA. In addition, they hid LASIK injuries from FDA
within the context of out-of-court settlement of innumerable lawsuits. Clinic-sponsored IDE studies
cherry-picked, withheld, and hid data from FDA that clearly showed LASIK with excessive adverse
event rates (greater than 1%). These activities were an industry-wide effort, organized wholly or in
part by the manufacturers and their collaborators in order to circumvent FDA law and regulation. I will
submit CONFIDENTIAL information on these matters separately to FDA’s Office of Criminal
Investigation.”
MSNBC invited Dr. Waxler to discuss his petition to end Lasik in a televised interview. The newscaster, who had
undergone Lasik, appeared defensive, and ended the segment saying, “I think I just focused mainly as
‘successful’ patients did, on the positive aspects of it, but you’ve given us a lot of food for thought”.
The FDA denied the citizen petition submitted by Dr. Waxler seeking the market withdrawal of approved Lasik
excimer lasers and a public health advisory on their continued use. The initial FDA whistleblower media story
had passed and there was no follow-up. This is where I am very much hoping that your unique show format
can take this story to the next level that it very much deserves to reach. The FDA must be exposed for its gross
negligence in violating its oath of protecting the public with regard to Lasik. Also, because of FDA negligence,
Lasik surgeons operate as if it’s the wild, wild west with impunity since FDA patient labeling is so broad and the
“white wall of silence” is so strong, that there is no legal protection for patients when they are not properly
informed of risks and suffer negligence.
Dr. Waxler is not alone in voicing his concerns over Lasik’s high risks. Laser eye surgery became a hot topic in
China when prominent a Taiwanese doctor disavowed the procedure in 2012 because of safety concerns.
The Purpose of Informed Consent
Any lawyer will tell you that the informed consent was and is, primarily, a device used for the protection of
doctors by doctors. They give it to you to protect themselves from lawsuits. That's not, obviously, how the
document was intended but it, like many well intended things, has had its use perverted by those with a selfserving agenda.
Initially the Courts viewed the failure to provide adequate information upon which one could base their
consent to have a surgical procedure as negating the consent itself. It made sense. If someone doesn't give you
all of the known information before you decide to go ahead, your decision to go ahead shouldn't be held
against you. The Courts treated operations occurring with defective consents as an unconsented touching or a
battery (in some states, an assault). In that way almost anything that happened could form the basis for a suit
against a doctor. The Courts came to hold that this approach placed too great a burden on the medical
profession.
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With Lasik, the pendulum has swung so far over that the patient is almost completely uninformed when
he/she signs the informed consent form to undergo Lasik surgery. The true information is contained in the
Labeling or Patient Information Booklet (PIB) of the laser.
The laser device labeling has two sections -- a section for physicians, known as Professional Use guide or
Physician Instruction Booklet, and a section for patients, known as Patient Labeling or commonly, the Patient
Information Booklet (PIB).
When the FDA approves an excimer laser, the agency issues an approval letter, which, until 2006, reminded
the laser manufacturer of the patient labeling requirement. Here are two examples. The first example is found
in a 2003 FDA approval letter for the VISX laser, and the second is found in the VISX
Physician Instruction Booklet Quote #1:
"Prospective patients, as soon as they express an interest in wavefront-guided LASIK for myopic astigmatism
and prior to undergoing surgery, must receive from the treatment provider the Patient Information Booklet..."
Physician Instruction Booklet Quote #2:
"All patients must be given the opportunity to read and understand the Patient Information Booklet and to
have all their questions answered to their satisfaction before giving consent for LASIK or PRK surgery."
Unfortunately, the FDA does not enforce this requirement upon physicians, leaving prospective patients with
insufficient information to make an informed decision to consent for Lasik surgery. Considering that clinical
trial data found in these booklets would likely lead most patients to decline LASIK surgery, it is not surprising
that LASIK surgeons withhold this material.
Post-operative complaints, such as halos, starbursts, difficulty driving at night, and persistent dry eyes are
commonly reported by patients at the endpoint of clinical trials, typically six months or one year. A review
published in 2007 of the twelve lasers approved from 1998 through 2004 found that six months after LASIK,
17.5% of patients report halos, 19.7% report glare, 19.3% report night-driving problems and 21% report dry
eyes which are worse than before surgery, much worse than before surgery, moderately severe or severe. This
review included so-called “newer technology”. Eye surgeons who profit from LASIK are not motivated to
inform prospective patients of these disturbing statistics. Moreover, surgeons generally dismiss these
complaints as "temporary side effects.”
In 2013, the FDA was questioned by Jim Dickinson, editor of the FDA-watchdog publication, Dickinson's FDA
Webview, regarding the Patient Information Booklet mandate, and its mysterious disappearance from the
laser approval letters in 2006. The agency acknowledged that it had used the now-missing language prior to
2006 as a condition of approval, and stated that it had revised the conditions of approval after an 'internal
review'. The FDA spokesperson said that it is the responsibility of the Lasik surgeon, who is not regulated by
the FDA, to provide patients with the booklets.
Does this make any sense -- the FDA requires laser manufacturers to produce LASIK Patient Information
Booklets, but they can just sit on a shelf somewhere without patients ever seeing them? The device side of the
FDA house is much weaker than the drug side in terms of protecting public health. Consumers can expect
enforcement of labeling and advertising regulations of FDA-approved drugs. Not so with FDA-approved
devices.
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If the public had a chance to view the FDA clinical trial data in the Lasik laser labeling (i.e. PIB) and interpret it
for themselves (so they could be in a position to provide true informed consent for an unnecessary surgery on
their most vital sensory organ), I think they would decide to keep their glasses.
FDA either a) works hand-in-glove with the Lasik industry or b) regulates them like a paper tooth tiger Three examples of the FDA regulating Lasik like a paper tooth tiger can be illustrated by viewing the four
minute Lasik introductory video on the FDA Lasik site. The three examples are:
1) “Before committing to surgery, be sure to get the laser manufacturers patient information booklet
(PIB) or labeling for your Lasik treatment from your eye doctor or FDA website. It provides more
information on the risks and benefits and what to expect before, during, and after the procedure” as
stated at the 3:55 mark of the FDA video. As stated above, everyone who has taken medication,
whether over-the-counter or by prescription, is familiar with the package insert or medication guide
that is supplied. This document contains important safety information, precautions, and instructions
for use. FDA-approved medical devices, such as lasers used in LASIK eye surgery, also come with a
guide, known as device labeling, which is mandated under U.S. federal law. Each excimer laser has
unique FDA-approved labeling, which contains outcomes of the FDA-required clinical trials. However,
Lasik surgeons are not required to provide this information to prospective patients. Instead, Lasik
surgeons can misinform patients by stating data that is completely contrary to the facts stated in the
labeling and the patient will make their “informed consent” decision based on this misinformation. The
patient then has no legal recourse because he/she signed an informed consent form just prior to
surgery that is generic and does not provide the valuable information contained in the labeling.
2) “In addition, doctors should examine patients for dry eyes, large pupils, and thin corneas since these
can also lead to bad outcomes” as stated by the FDA at the 1:50 mark of the FDA video. Large pupil
size is a known contra indicator for Lasik Yet the FDA, through pressure from the Lasik industry, has
refused to include large pupil size as a contra indicator for Lasik in the patient labeling for over twenty
years. Ophthalmologists have pushed the FDA into keeping the large pupil size contraindication
language out of labeling. By keeping the language out of labeling, negligence cannot be proven in a
court of law when Lasik is performed on patients with large pupils.
Lasik patient advocates allege that the industry creates its own science, particularly with regard to
pupil size, with little regard for scientific integrity. The FDA has relied on “junk science” from Lasik
surgeons. An example can be seen in Dr. Steven C. Schallhorn’s “myth busting” talk in February 2012
where he stated that large pupils are not at greater risk of quality of vision symptoms after Lasik
despite ample scientific evidence to the contrary. Dr. Schallhorn has also testified as an expert witness
against large pupil patients in Lasik malpractice cases. Dr. Schallhorn has even testified in the
courtroom while decorated in his Navy military uniform which, at a minimum, is unethical since he was
not representing the U.S. Navy but instead he was providing his personal testimony as a physician.
3) “Ask your eye doctor to provide you with your eye measurements before the Lasik surgery. You
should keep them with your other important papers in case you need cataract surgery in the future.
It will help your doctor calculate the lens implant power” as stated at the 3:12 mark of the FDA
video. LASIK surgery results in miscalculation of lens implant power for future cataract surgery. In
2008, the FDA announced on its web site that it had "worked with the American Academy of
Ophthalmology to develop a card [K-card] that physicians can fill out with the patient’s eye
measurements before their LASIK surgery." Unfortunately, LASIK surgeons rarely provide patients with
a K-card. Paula Cofer, the founding director of Vision Surgery Complications, Inc., stated in response to
the FDA denial of Dr. Waxler’s citizen petition, that virtually no LASIK practitioner provides the k-card
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to patients because doing so would alert patients to long-term consequences of LASIK, which were not
disclosed prior to surgery.
Retention of medical records by healthcare providers is required by state laws; however, in many
states medical records may be destroyed after five years. The majority of LASIK patients in the United
States are not aware of the need to obtain their pre-LASIK eye measurement records. Therefore, it is
incumbent upon the FDA to include this information in a public health advisory concerning LASIK eye
surgery.
Lasik surgeons circle the wagons to protect their cash cow in litigation. An injured Lasik patient who decides
to sue his/her surgeon must first find an expert witness. Lasik surgeons rarely testify against one another – if
they do, they face backlash from their peers. Several years ago, a then-famous Canadian eye surgeon who
testified on behalf of a commercial airline pilot in Arizona who could no longer fly after Lasik was thrown under
the bus by his peers after the pilot won a $4 million jury verdict against his Lasik provider. The eye surgeon
later recanted his testimony, but his reputation and standing in ophthalmology circles never recovered.
Lasik surgeons were given an edict not to violate the “white wall of silence” that then-Chief Medical Editor of
EyeWorld magazine, Dr. Marguerite B. McDonald, called for in a July, 1999 editorial, saying:
"We are only starting to ride the enormous growth curve of LASIK in this country. There will be more
than enough surgeries for everyone to benefit if we keep our heads by sharing information openly and
honestly and by resisting the temptation to criticize the work of our colleagues when we are offering
a second opinion to a patient with a suboptimal result. Who was it who said, "When the tide comes
in, all the boats in the harbor go up?"
LASIK patients with complications are routinely told to "give it time" while the clock ticks down on the statute
of limitations for filing a medical malpractice lawsuit.
When asked how to proceed with a LASIK patient who developed a severe, vision-threatening complication,
world-renowned Lasik surgeon and author of several Lasik books, Louis E. Probst, MD, said: "The most
important step in this patient's care is to ‘kill him with kindness’. The statute of limitations for medical liability
may not have expired in some states."
Similarly, Eric D. Donnenfeld, MD, a Lasik industry leader, urged his peers to refrain from helping litigants
injured by Lasik, saying "When there are large gray areas or your views are discrepant with the norm, please
keep your opinion to yourself and outside of a court of law".
It's the same culture of deception that surrounded Big Tobacco when evidence was mounting against smoking.
Big Tobacco insisted that smoking was safe and not addictive. What distinguishes the Lasik scandal from the
Big Tobacco sandal is the fact that the perpetrators of the Lasik scandal are a close-knit group of ‘trusted’
doctors wearing white coats. Society teaches us to trust doctors. But Lasik surgeons are a different breed of
physician who’ve abandoned the practice of medicine to sell a lucrative, medically-unnecessary surgery. Like
Big Tobacco, Big Lasik keeps the harm concealed behind a smokescreen of misleading claims and outright lies.
Lasik industry significantly downplays risks: Dry eye disease after Lasik is downplayed by Lasik surgeons; but
dry eye is the most commonly reported reason for dissatisfaction with Lasik. Researchers found that severe dry
eyes has an impact on quality of life comparable to severe angina or disabling hip fracture. In fact, many Lasik
patients are incapacitated by their dry eyes. Medical studies employing microscopic examinations of the
cornea after Lasik demonstrate that damage to corneal nerves during the Lasik procedure leads to neuropathic
dry eyes and corneal neuralgia (eye pain).
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Night vision problems affect a large percentage of Lasik patients. In dim light when the pupil dilates, light
passes through a larger area of the irregular surface of the post-Lasik cornea. If the pupil dilates beyond the
lasered optical zone into the blend zone or beyond, the patient will see aberrations such as starbursts, halos,
and ghost images, and contrast sensitivity will be reduced. The image below-left illustrates how a person
wearing corrective lenses sees a pedestrian and an oncoming car at night. The image below-right illustrates
how a Lasik patient with severe visual symptoms may see the same scene (notice the pedestrian is obscured by
the starburst from the headlights).
Who needs research to understand the relationship between severe starbursts or severe halos and quality of
life? The quality of life impact is obvious.
Suicidal Ideation with 20/20 Vision; Like the general public, prospective Lasik patients believe that 20/20
means good vision. LASIK surgeons tout Lasik based on the percentage of patients achieving 20/20 vision, but
they conceal the fact that 20/20 vision may be a waking nightmare after Lasik. FDA-required clinical trials
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demonstrate that Lasik reduces "quality of vision", even with the latest FDA-approved technology. Consider
the two eye charts below. The 20/20 line is legible on both.
After LASIK, a patient may have "quality of vision" as poor (or worse) as the eye chart on the right. Adding
insult to injury, the surgeon insists that the surgery was a success since the patient has 20/20 vision per the
eye chart standard.
Visual acuity is meaningless as a predictor of psychological adjustment post-Lasik. Patients can have 20/20 or
better vision, and still experience the desire to end their own life. Suicidal ideation expresses a desire for relief.
In general, patients who are more damaged will have more suicidal ideation.
Lasik surgeons have attempted to write-off patients suffering from Lasik injuries as having some other root
cause not associated with Lasik injuries. Lasik surgeons have long asserted that patients who complain of Lasik
injuries suffer from perfectionism or there is some other root cause for post-Lasik depression/suicidal ideation
or there are other issues such as body dysmorphic disorder.
The Lasik surgeon’s basis for “success” is the patient’s ability to read the 20/20 line on the Snellen Chart.
However, a person can be 20/20 with debilitating and unremitting eye pain and/or dry eyes (as is the case for
me), or can be 20/20 with night vision disturbances such as starbursts or halos, or can be 20/20 with significant
loss of “quality of vision”.
Assertions that there is some other root cause for post-Lasik depression/suicidal ideation is flawed.
o 80 percent of the information your brain takes in comes through your eyes. It is for this reason that
Lasik complications often lead to depression, suicidal ideation, and in some cases, suicide. At least
seven suicides have been linked to complications from Lasik, bolstering Lasik patient advocates’
position that unremitting eye pain or impaired vision can exact a severe emotional toll. This is
consistent with research linking other forms of visual impairment to poor health and increased risk of
suicide. However, renowned Lasik surgeons have consistently rejected any connection between a bad
outcome from LASIK and suicide, even mocking suicidal Lasik patients with an American Eyedol skit
featuring a contestant named “I am Suicidal” and a SNL Weekend Update skit again featuring “I am
Suicidal.” Both of these skits were performed at the annual ASCRS convention in 2012.
Assertions of perfectionism seem designed to…
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o
o
o
o
o
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Protect the doctor’s ego: The surgeon or surgery can’t be imperfect if the patient is shown to be
imperfect.
Insulate the doctor from the reality of having tragically damaged another human being.
Undermine complaints about dry eye and higher order aberrations on quality of life.
Protect the surgeon from possible legal action.
Assertions of perfectionism rest on a common assumption: That all surgeries produce somewhat
imperfect vision, and that patients should be prepared to deal with a certain “normative level” of
visual impairment.
If this is true, then why was it never systematically studied in clinical trials?
Assertions of perfectionism have no empirical basis. There have been no studies that specifically
examine perfectionism among post-LASIK patients.
The Lasik surgeon assertion of body dysmorphic disorder is equally flawed …
o Patients with Body Dysmorphic Disorder are concerned with features felt to be the object of public
observation and potential embarrassment or ridicule.
o Vision is not subject to public observation, and therefore cannot constitute a basis for Body
Dysmorphic Disorder
o Diagnoses of Body Dysmorphic Disorder simply reflect ophthalmology’s poor understanding of
psychology. Refractive surgeons are not psychologists.
No plan B fix for Lasik complications: You might think a patient with poor vision after Lasik surgery can go back
to wearing glasses, but visual distortions caused by LASIK are not correctable with glasses. That’s because Lasik
leaves the cornea with an irregular, optically-poor shape. In addition, there is no plan B fix for properly
restoring the tear film in the case of severe dry eyes or correcting night vision disturbances when pupil sizes
exceed the treatment zone of the laser causing night vision disturbances.
A writer for the Raleigh News & Observer reported on 2/3/08, “Laser eye surgeons who treat patients with
complications say they do come across cases of depression, but they don’t think Lasik complications are the
root cause. They say patients who exhibit depression after the procedure were likely depressed or
psychologically troubled beforehand. ‘There’s no cause and effect,’ said Dr. Steven C. Schallhorn, the former
head of the Navy Refractive Surgery Center in San Diego.”
Dr. Jennifer Morse, a psychiatrist and consultant for ASCRS, stated in her testimony to the FDA on 4/25/08
that, “There is no scientific evidence of any direct link between LASIK and the development of depression or
suicide.”
American Olympic bobsled champion, Steve Holcomb, attempted suicide after his failed Lasik surgery left him
with a progressive, debilitating eye disease known as corneal ectasia. After miraculously surviving the suicide
attempt, Holcomb underwent an experimental surgery to save his eyesight by a California eye surgeon who
now uses Holcomb’s name to promote his Lasik practice.
Roger D. Davis, Ph.D. presented his findings to the FDA in 2008 based on research he conducted in a paper
titled “Depression, Suicide, and Lasik Complications.” The paper was based on a full presentation (also
included in the same link beginning on page six) documenting the effects of “Refractive Surgery Shock
Syndrome: Depression, Posttraumatic Stress, Suicidal Ideation and Complications of Refractive Surgery.”
Roger Davis studied suicidal ideation in the Complications of Refractive Surgery (CORS) Study. He found the
following results.
• 48 of 58 (83%) patients who admitted to suicidal ideation said they were told they were a success by
their surgeon
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•
•
•
87 of 115 (76%) patients who admitted to depression said they were told they were a success by their
surgeon
Dry Eye had the strongest association with depression and suicidal ideation
Higher order aberrations such as halos and starbursts were as strongly associated with suicidal
ideation as blurry vision (classically a lower order aberration).
Lasik leads to blindness in some patients: Spice Girl is now blind in one eye due to Lasik.
Kathy Griffin has reduced vision in one eye from Lasik performed by one of “best” Lasik surgeons in the
country, Dr. Robert Maloney, from Beverly Hills, CA.
Ectasia is the most feared Lasik complication, with most cases never reported to the FDA. Corneal ectasia may
present years after seemingly successful LASIK. In an apparent attempt to hide the truth about post-LASIK
ectasia, LASIK surgeons may deliberately misdiagnose post-LASIK corneal ectasia as post-LASIK keratoconus.
Keratoconus is a naturally occurring disorder of the cornea which usually affects both eyes and typically
begins during puberty or late teen years. If a patient did not have keratoconus, forme fruste keratoconus,
strong family history of keratoconus, or early signs of keratoconus before LASIK and experienced steepening of
the cornea with vision loss after LASIK, then the correct diagnosis is likely ectasia.
Is post-LASIK ectasia (keratectasia) real, or is it actually genetic keratoconus hastened by LASIK, as some LASIK
surgeons would have you believe? Read this scientific study, which found that post-LASIK ectasia and
keratoconus are not the same histopathologic processes.
Listen to the presentation given during a private meeting of LASIK surgeons, in which the speaker admits that
ectasia cases are not being reported (as required by federal law), and that the rate of post-LASIK ectasia is
likely "a lot higher" than 1%. Says speaker, "... I think the keratectasia incidence is a lot higher, just like you
alluded to, but it's not being reported because of the litigious nature of what's going on. A lot of us obviously
don't report it because these are patients being referred in to us."
The perpetrators of this crime are physicians who are trusted by society and have the endorsement of the
FDA which functions as a powerless organization on the ophthalmic device side. There has never been a
Lasik public health advisory or proper informed consent provided to prospective patients. At times, you will
hear Lasik surgeons provide lip service with statements such as this; "As eye care professionals, we must keep
up with the latest technology on refractive surgeries and always advise our patients as to the costs, risks, and
benefits on any therapy or surgical procedure that is recommended. We must advise our patients to “do their
homework” and to make them aware of the fact that serious problems can occur under the best of
circumstances."
But how does the FDA and Lasik surgeon inform patients when they do not provide patients with the Lasik
laser labeling or Patient Information Booklet that shows 20% of patients experience long-term/permanent dry
eyes and/or night vision disturbances; even with the most current laser technology? Do Lasik surgeons provide
patients with photos of what night vision disturbances actually look-like? No. If Lasik surgeons mention night
vision disturbances at all, these issues will be downplayed by the surgeon and his staff as “temporary side
effects” with abstract terms like glare and halos (despite PIB data showing these “side effects” are commonly
reported by patients at the endpoint of clinical trials, typically six months or one year). How can a prospective
patient possibly be informed of the true risks of Lasik if this information is withheld from them?
Some might ask if Lasik is so bad, then why don’t more people speak out against Lasik? Before I explain why
more people do not speak out, it should first be noted that you will find more patient websites dedicated to
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warning the public about the dangers of Lasik than any other elective or non-elective surgery. Here is a list of
websites that exist for the sole purpose of warning the public about the dangers of Lasik.
http://eyefreedom.com/lasik-complications/ :: Dr. Edward Boshnick maintains a cutting edge optometric
practice devoted to the restoration of vision and comfort lost as a result of refractive eye surgery (LASIK, PRK,
RK, etc.), keratoconus, pellucid marginal degeneration, extreme dry eye, corneal dystrophies, corneal trauma
and Stevens-Johnson Syndrome.
LASIKNewsWire.com :: LASIK news and information. Press releases, medical studies, special reports. Hardhitting reporting on the LASIK industry and the medical cover-ups surrounding the practice of LASIK. Learn
about the FDA's role in hiding the truth about LASIK risks from the public.
LasikScandal.com :: Providing readers with the most accurate and unbiased truth on what is currently a major
health crisis, LASIK, laser eye surgery, and other forms of refractive eye surgery. Approval of Laser Vision
Correction / Laser Eye Surgery (LASIK, LASEK/PRK) is a type of medical fraud -- the mission of this site is to
expose it. Every eye treated by laser ablation demonstrates permanent and irreversible damage. This is
unacceptable for an unnecessary, elective surgery.
LasikHope.com :: This website was created to let you know that there is hope and help available for those who
have lost quality vision and ocular comfort due to refractive eye surgery including LASIK. Dr. Boshnick's
specialty eye practice is devoted to the non-surgical restoration of vision to those who have undergone
refractive eye surgeries such as LASIK, Radial Keratotomy, PRK and a host of other risky elective refractive
surgical procedures.
Lasik Hope.Com - Joe Tye Lasik Videos :: Motivational speaker and values coach Joe Tye (see
ValuesCoachInc.com and JoeTye.com) has created many videos about the LASIK industry.
Lasik Dangers Blog :: Exposing the truth and calling to outlaw a dangerous and unnecessary cosmetic surgical
procedure. Learn about Patient Information Booklets (PIB), which contain important safety information and
clinical trial outcomes for each FDA-approved laser. LASIK surgeons are required to give a booklet to every
prospective LASIK patient prior to undergoing LASIK. LASIK surgeons routinely fail to provide patients with
these booklets because the data from the clinical trials shows high rates of complications. Learn how to
download your booklet from the FDA website.
HelpStopLasik.com :: I am Morris Waxler, PhD. In 1998, I was the FDA's chief scientist in charge of the clinical
trials research for laser eye surgery, popularly known as LASIK. Based on my recommendation, the Food and
Drug Administration approved LASIK. In January 2011, after an independent, exhaustive review of the current
data, I petitioned the FDA to withdraw its approval for all LASIK devices and to issue a LASIK public health
advisory. Register on the site to Help Stop LASIK.
LasikAdvisory.com :: Lasik Advisory was born to warn! Blog created to warn the public about the hidden risks
of LASIK, and to expose corruption surrounding the FDA-approval of LASIK. Watch "In the Blink of an Eye", a
LASIK documentary and true story of how the LASIK industry deceived the FDA and covered up patient injuries
for financial gain.
Mike's LASIK Hell :: Mike's LASIK Hell was created to help expose the dishonest, corrupt, and dangerous LASIK
industry that many patients have fallen victim to. Without websites like this and many others, potential
patients would only see the false information advertised by the doctors and industry who profit from LASIK...
Potential patients should be aware of the dishonest, unethical, and illegal tactics used by my doctors to dupe
me into a procedure that I would not have consented to if properly informed and not lied to.
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lasikcirurgia.blogspot.com :: Portuguese Lasik blog created by anti-LASIK activist to warn Portuguese-speaking
prospective LASIK patients about the dangers of LASIK and the hidden complications in clinical trials.
http://lesdangersdulasik.com/ :: French
https://afectadoslasik.wordpress.com/ :: Spanish
http://lasikmutualjapan.jimdo.com/ :: Japanese
FDA's Lasik Page :: Although there is plenty of good information on the site, it falls way short of adequately
warning prospective patients. Some sections almost read like an advertisement for LASIK. The "Other
Resources" page contains links to LASIK surgeon organization sites, which are heavily biased. Even so, we
believe that prospective patients should read it before deciding to have the surgery.
LasikSurgeryWatch.org :: LASIK Surgery Watch (LSW) is a non-profit LASIK patient advocacy organization. LSW
was launched in 2008 by a group of LASIK patients and family members of LASIK patients to address an urgent
need for improvements in quality of patient care in the practice of LASIK. In contrast to the LASIK industry's
focus on patients who are "satisfied", the LSW slogan states "Every Patient Counts". The organization
welcomes and encourages all LASIK patients with poor results to register on its website.
MyLasikStory.com :: From the website: "My name is John Hoge and this page is the chronicle of my personal
experience under the care of Dr. Eric Donnenfeld... On my first day after the surgery, my vision started to
improve beyond what it had been without contact lenses, but I began to notice some problems. Spotlights at
night produce horrible glare. Reading became difficult, and my reading speed was drastically reduced.
Sometimes objects seem to project a fuzzy haze against their backdrop. I had never experienced anything like
this. Vision was very simple before Lasik - fuzzy without contacts and crystal clear with contacts. Now I had a
whole new world of problems..."
LasikFDA.com:: Exposes deceit, corruption, and collusion by the FDA and the LASIK industry. From the site:
"You've read the hype about the 10-minute miracle. Now get the truth." Reports the events of the 4/25/08
hearing of the Ophthalmic Device Panel with videos and transcripts of testimony. Shows parallels between Big
Pharma and Big Tobacco and "Big LASIK".
Keith Wills LASIK Story :: I would like to know why we were not protected against this doctor and why the FDA
failed us in this matter. We tried to obtain copies of the official documents to use in our medical malpractice
lawsuit, but the FDA, stated they were confidential and they would not be released. Those documents could
have been presented to the jury showing that this was not an approved laser, and that the doctor had even
misled the government by providing inaccurate reports, documents and representations.
TheLasikReport.com :: A comprehensive review of the medical literature of LASIK. Examines medical studies
which reveal the risks and long-term consequences of LASIK. Cites 43 peer-reviewed journal articles. The
report concludes that LASIK in an inherently harmful procedure and should be abandoned.
VisionSimulations.com :: Created by author and psychologist Roger D. Davis, PhD, this site features
photorealistic images of the visual aberrations included by LASIK and other refractive surgeries, including
starbursting, halos, glare, ghosting, blurry vision, and night driving scenes. Also contain numerous animations,
as well as simulators that allow patients to approximate and communicate their vision to friends, family, and
physicians. If you want help simulating your vision for others, start here.
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LASIKDisaster.com :: Highest search engine-ranked LASIK patient site on the internet. Exposes the LASIK
industry for covering up complications and deceptive advertising. Legal resources for victims of LASIK medical
malpractice. Medical research of LASIK complications and risks. News articles about LASIK complications.
Images of damaged eyes.
LasikMemorial.com :: Dedicated to those whose lives have been damaged or destroyed by refractive surgery,
this site contains true stories written by the victims themselves. When complications occur, your life splits in
two. There is the person you were before LASIK, and the person you are now... You realize that maybe human
nature isn't fundamentally good, or at least that doctors aren't what you thought they were.
LifeAfterLASIK.com :: Created by activist, Dean Kantis. Warns about bad doctors that harm patients. Cautions
prospective patients about LASIK marketing scams that sell fake certifications and entice patients into having
surgery by downplaying complications. Publishes stories of patients with bad outcomes. Links to YouTube
videos about LASIK horror stories.
UpdegraffLasik.com :: Created by LASIK patient who experienced a life-altering bad outcome, and now doesn't
feel LASIK should be advertised without disclosing contraindications, risks, and warnings. The patient built this
website in protest to the heavy advertising of Stephen Updegraff, MD. The site warns about the potential
complications of LASIK and the unique problems of all-laser, bladefree, IntraLase femtosecond laser LASIK.
These websites are run by people who know from their own personal experience how a bad Lasik outcome can
diminish the quality of one’s life. When you have one of these websites, you also hear from scores of
individuals who also experience bad Lasik outcomes. I urge you to listen to testimony provided to the FDA on
4/25/08 from Rebecca Petris, who runs dryeyezone.com and tells her story of feeling “like a triage nurse with
all of these people (injured Lasik patients) coming, seeking help for whom I don’t have enough answers.”
While there has been a small group of thoughtful, committed citizens who have put up websites to inform the
public of the true risks of Lasik, most individuals injured by Lasik do not speak out publicly against the surgery.
There are several for this but one major reason is that society does not look as favorably upon the injured Lasik
patient advocacy cause as it does with other medical causes. Injured Lasik patients do not have well-organized
support groups. Maybe part of the reason that the public does not sympathize with people suffering from Lasik
complications is because Lasik is an elective surgery — we did this to ourselves. When injured Lasik patients
speak out, we are immediately confronted by a person who says he knows 10 people who’ve had Lasik and
they’re all happy. Which leads me to my next point about happy Lasik patients…
Psychological Defense Mechanisms after poor Lasik results: Cognitive Dissonance and 20/Denial; Cognitive
dissonance (Festinger, 1957) is one of the most widely discussed theories in social psychology. Cognitive
dissonance results in thousands of people suffering from Lasik injuries who claim to be “satisfied” or “happy”
with the results. Dr. Leo Maquire once wrote the following in an ophthalmology editorial: "The keratorefractive literature contains disturbing examples of patients who have visual handicaps that place themselves
and others at significant risk for nighttime driving accidents, and yet they are happy with their results."
One of the most perplexing cases of patient satisfaction comes from a 2007 report of a patient who developed
bilateral ectasia, a serious sight-threatening complication which may require corneal transplantation, who was
reportedly satisfied with his surgery.
Again, the question that one must ask is … why would a patient be “satisfied” if he was left with a permanent
injury from Lasik surgery? A big part of the answer is cognitive dissonance. Lasik surgery is permanent. It
cannot be returned like a bad pair of glasses. With cognitive dissonance, we reinforce the decisions in our life
by disparaging all the other choices not made. Examples of dissonance include:
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o
o
o
“Yeah, I have to use eye drops all day, but I’m still glad I had Lasik.”
“I have double vision, but at least I don’t wear glasses anymore.”
Those in denial do not contribute to complication rates, and make the surgery appear safer and better
than it really is.
As illustrated from these examples, patients can suffer significant complications or "symptoms," and still claim
to be satisfied patients. Patient satisfaction surveys in LASIK are guaranteed to lead to skewed results and
significant false positive data.
The Lasik industry markets that “95% of Lasik patients are satisfied” but yet even with the latest technology,
FDA clinical studies and independent surveys show that patients experience long-term/permanent
complications or “side effects” at an alarmingly high rate (see labeling/Patient Information Booklet of most
current Lasik lasers) and Consumer Report survey data below.
Consumer Reports survey data supports Lasik labeling/PIB and contradicts Lasik industry data. The
Consumer Repors survey published in August 2009 found that 55% of Americans who had laser eye surgery
continue to wear glasses or contact lenses at least some of the time, and many say they were misled by
advertising that suggested they would be free from glasses permanently. The survey found that 53% of
patients experienced at least one side effect during the first month after surgery, and 22% continued to
experience side effects six months after surgery. The most commonly reported side effects were dry eyes and
visual symptoms of halos, glare, and starbursts around lights.
In a 5/22/2009 letter to Eye Care Professionals, the FDA warned that Lasik ads which fail to inform consumers
of Lasik risks are illegal and endanger public health. Yet Lasik providers completely ignored the letter, and
continued to advertise Lasik as if it were as safe as a tooth whitening procedure.
Unethical Lasik Promotional Practices: When Doctors Fail the Integrity Test; The Lasik Advertising Network is
a company that teaches Lasik surgeons how to convince reluctant prospects to go ahead with the surgery. This
is a direct quote from the company's website:
"... our clients have enjoyed some of the highest volume success rates in the county. With a deep
understanding of the consumer psychology of a LASIK patient, our results-driven LASIK marketing campaigns
not only compel consumers to have LASIK but to have LASIK with you... today!"
Think about what this is saying. This company teaches Lasik surgeons to use sophisticated psychological
profiling (e.g. preying on the insecurity of young people worried about their appearances) in order to "compel"
them to submit to a high-risk surgical procedure that could result in a lifetime of misery. And not just "compel"
them to have the surgery - compel them to have it "today" - before they've had a chance to ask questions,
research the potential complications, check references, or think twice about the risks they are taking with their
precious eyes.
This is not just bad medicine, it is a violation of the Hippocratic Oath and profoundly unethical. Lasik is an
unnecessary surgery that can result in ruining someone's life, the way it has in at least seven documented
suicides. There are also thousands of people like me for whom getting Lasik eye surgery was the worst mistake
of a lifetime (I ended up with intractable severe eye pain, dry eyes, and impaired visual acuity).
Lasik patient advocacy communication with FDA falls on deaf ears: In a 9/13/2009 letter to FDA’s director
over medical devices, Jeffrey Shuren, M.D., Lasik Surgery Watch (LSW) called the agency out on its “grossly
negligent” approval of LASIK, and said, “It is reasonable to conclude that LASIK eye surgery has become a
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leading cause of preventable visual impairment in the United States.” The patient group pointed to the
agency’s guidance document for LASIK lasers which states that adverse events should not exceed 1%, yet the
agency approved LASIK with more than 20% of patients reporting persistent problems, such as glare, halos,
night driving problems, and dry eyes at the end of the clinical trials. (Several glasses-wearing ophthalmologists
on the FDA advisory panel brushed off the problems in voting for approval).
Two months later Dr. Shuren received another letter from a group of 126 individuals calling for a LASIK public
health advisory. Dr. Shuren did not respond, even though hundreds of Lasik injuries had been formally filed
with the agency. But in 2006 the FDA issued a public health notification after learning of 109 cases of
suspected fungal keratitis infection from use of contact lenses. Lasik surgeons seized upon this opportunity to
scare patients into having Lasik, making preposterous claims that Lasik is safer than contact lenses.
Incidentally, the agency issued a public health advisory in 2009 after receiving 130 reports of smell loss from
use of a cold medicine. You’d think that eyesight is at least as important as sense of smell. (The FDA’s database
currently contains thousands of Lasik injuries, even though most injured patients are not aware that they
should file a report.
FDA performs post-Lasik quality of life (QOL) study in attempt to distance itself from scientific data that proves
that Lasik is dangerous. Per Morris Waxler, PhD, “the FDA does not want to admit that millions of people have
now had a surgery that never should have been approved by its own rules. The FDA is now engaged in
covering-up a scandal and an epidemic, and its own corrupt practices. This should be exposed, and LASIK
should end.”
As of 2008, Lasik patient advocates had been crying foul to the FDA for at least fifteen years. Citizen petitions
and a barrage of angry letters and emails culminated with the FDA holding a public hearing of outside experts
in 4/25/08. At the hearing, two medical doctors, two optometrists, three psychologists, and a number of
injured patients presented compelling information establishing a causal link between bad LASIK, depression,
and suicide. It had been determined prior to the meeting that the FDA would perform a post-Lasik quality of
life (QOL) study.
Due to the FDA and Lasik industry delaying the process, it is now seven years later (2015) and only the
preliminary phase of the QOL study has been completed at a budgeted cost of $1M+ to U.S. taxpayers.
Once Dr. Waxler came forward and shined the light on the issues, the FDA realized that it had no basis for
further inaction. The fact that the FDA gave Lasik approval with an adverse event rate of 20% when the original
FDA guidance document for LASIK lasers clearly stated that adverse events should not exceed 1% was a major
mistake that has led to a public health crisis. However, the FDA devices group does not admit to major errors.
The head of the FDA ophthalmic device panel is Malvyna Eydelman and she completely caters to the
Ophthalmology industry. She also happens to be an Ophthalmologist who is all too eager to rub elbows with
her peers at ophthalmic conferences while the public continues to be grossly misinformed about Lasik risks.
In a long-awaited report on the collaborative study it conducted on the post-surgical quality of life (QOL) of
LASIK patients, the FDA is downplaying the harms it found in up to 45% of 572 patients, adopting the industryfavored term "visual symptoms" vs. the agency's former use of the terms "adverse reactions" or "adverse
events." Delivered by CDRH ophthalmic devices chief Malvyna Eydelman at a LASIK-friendly forum staged by
the American Academy of Ophthalmology (AAO) on 10/17/14 in Chicago, FDA's report said "some" patients in
the study developed "problems" after surgery like "difficulty driving at night or in sunshine, [that] severely
impacted a patient's daily living, and included debilitating vision symptoms (seeing starbursts, glare, ghosting,
or halos) and severe dry eye."
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The real numbers of the post-Lasik quality of life (QOL) study that took seven years to complete (only initial
phase is completed to date) show:
• Up to 45 percent of participants, who had no visual symptoms before surgery, reported at least one
visual symptom at three months after surgery.
• Participants who developed new visual symptoms after surgery, most often developed halos.
o Up to 35 percent of participants with no halos before LASIK had halos three months following
surgery.
• Up to 30 percent of participants with no symptoms of dry eyes before LASIK, reported dry eye
symptoms at three months after their surgery. This is consistent with previous studies.
The post-Lasik quality of life (QOL) study says nothing about psychiatric problems, depression and suicide
linked to adverse LASIK outcomes; its limited scope (three months post-surgery), small subject base, and
questionable scientific integrity (as discussed in the section below) virtually assured it would not reach those
associations.
FDA's collaborators in the study were the National Eye Institute and the Department of Defense (especially the
pro-LASIK Naval Medical Center in San Diego which encourages service personnel to undergo LASIK and
performs most of the LASIK procedures that ensue). Dr. Steven C. Schallhorn, the former head of the Navy
Refractive Surgery Center in San Diego was quoted in a Raleigh News & Observer report on 2/3/08 as saying
‘There’s no cause and effect,’ between bad Lasik and depression despite scientific evidence and patient
testimony evidence to the contrary. Now the FDA was going to the same Navy Refractive Surgery Center in San
Diego to perform the post-Lasik Quality of Life study.
"The findings from this study will help to refine our current thoughts on the labeling for LASIK devices which
will be incorporated into our patient labeling guidance," the report says. "In addition, we will ensure our Web
site reflects these findings to better inform consumers of the potential outcomes following LASIK."
As you can see, under Malvyna Eydelman’s leadership, informing the public in essence means updating the
FDA website on Lasik since the FDA updates the labeling but the Lasik surgeons do not provide the labeling
information to patients. This is a pathetic display of leadership from an FDA official during a time when
people’s eyes are being permanently damaged and people are literally committing suicide from an
unnecessary surgery. Note that to add insult to injury, Ms. Eydelman does not even update the FDA website
well. The only images on the FDA site of night vision disturbances such as glare, halos, and starbursts are
shown on the four minute Lasik introductory video beginning at the 2:10 mark. You can see that the FDA is
grossly misinforming the public with images of glare, starbursts, and double vision shown as “severe” on the
video that patients would consider “moderate” (refer to images shown earlier in the letter for images of
severe glare, starbursts, and double vision described by many patients suffering from Lasik higher order
aberrations).
My Lasik story: My Lasik surgery was done in 2006 using the latest intralase wavefront technology (yes,
believe it or not the intralase wavefront laser is still the latest technology in 2015 as well despite marketing
claims that there is always a newer technology). For the past nine years I have suffered from unremitting eye
pain that is now partially controlled by medication. My first eighteen months post-Lasik was pure hell. I can
honestly say that I have experienced pain that only the smallest fraction of the population would know exists.
Pain receptors in the cornea is 300-600 times greater than skin and 20-40 times greater than dental pulp,
making any injury to the cornea excruciatingly painful. In my case, the pain was turned on 24/7 for 18 months
until the correct pain medication cocktail was found to turn the pain partially off.
I saw six different ophthalmologists in the first eighteen months post-Lasik, and they all discounted my pain as
basic dry eye (my Lasik surgeon even said that I should be happy because I see 20/20). However, the pain was
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not due to dry eyes but instead was caused by corneal neuralgia, a Lasik complication that is just recently
beginning to be recognized (20 years after Lasik’s inception in the U.S.). You can see my testimony at the FDA
Ophthalmic Devices Panel hearing here. You can also view my wife’s testimony at the same hearing here.
Summary: If you have reached this point and are still unsure as to whether you should do a show on Lasik, I
strongly urge you to read stories from patients who have written into the FDA. I’ve included a few patients’
stories at the end of this letter from the over one thousand stories in the FDA database. I doubt anyone with
any authority at the FDA actually reads these reports. There are thousands of stories like these not reported
to the FDA. Most people don’t know about the FDA Maude system. Some know about the FDA Maude system
but don’t bother filing a report. For some of these patients, they know that it’s been over 20 years since Lasik
was approved by the FDA in the U.S. and the FDA has done nothing to properly inform the public of Lasik risks.
Other patients feel that writing into the FDA will do nothing to restore their family’s life to normal.
The Lasik industry attempts to paint the picture of their being “only a few dissatisfied patients”. I wish that
more patients suffering from Lasik injuries would speak out. If they did, Lasik would have ended long ago.
Instead, Lasik is still around today ruining uninformed consumers lives on a daily basis.
For the 1,000+ injured Lasik patients who have written in to the FDA Maude database system, they have
learned that the FDA Ophthalmic Devices group led by Malvyna Eydelman is merely a “black hole” of inactivity
that has absolutely no interest in informing the public of Lasik risks (aside from doing a poor job of updating
the FDA Lasik website and very rarely updating the Lasik laser labeling that prospective patients will never see).
There are thousands of stories like these. Patients suffering with Lasik injuries should not continue to exist as
victims without a voice. An additional summary point that cannot be understated is that Lasik is an
unnecessary eye surgery. Bad outcomes from an unnecessary surgery should not result in destruction of
quality of vision, eye pain, or dry eyes so severe that people that previously happy people are driven to suicidal
ideation and even suicide. This should not even happen to less than 1% of the patients. And if it does, the
public should certainly be properly informed about these risks. The reality is that the risks are much higher.
In addition, Ambulatory Surgical Centers (ASCs) where Lasik is performed are required to report adverse
events to the FDA or directly to the laser manufacturers, but ASCs ignore FDA rules and almost never file these
reports. On the rare occasion that the ASCs do file a report, it is typically made to the laser manufacturer
complaining about laser device malfunction (the ASC typically does not provide additional information about
the patient). The laser manufacturer then goes to the ASC site for an inspection of the laser, performs testing,
and writes on the FDA Maude report that the laser is performing properly and no additional information was
provided by the Lasik surgeon/ASC.
Lasik providers and facilities ignore mandatory reporting of adverse events, as stated – one reason for
artificially low numbers of Lasik injuries. When the FDA sent out inspectors to Lasik facilities in 2009, all
facilities inspected were found in violation of laws requiring tracking and reporting of adverse events.
As you can see, there is a lot of content to cover in order to expose the darker truths of Lasik that are not well
known, but which are essential to recognize if the public is to be informed. I am very hopeful that you can
commit one of your 10-13 minute segments on Lasik and have it carryforward in a manner similar to your story
on FIFA. Even one standalone segment would be a great public service and you have plenty of material to
select from. I realize that you can’t fit everything written in this letter in a 10-13 minute segment. However, I
am certain that whatever you put on television will be better than anything done before. Perhaps you can
shame the FDA for their complete inaction and create a Lasik public health advisory to let the public know that
dry eyes and night vision disturbances occur approximately 20% of the time in the long-term/permanently per
FDA clinical studies. You can use the images included above and additional images. A picture is worth a
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thousand words, yet the FDA does not provide proper pictures of night vision disturbances on its website
(despite repeated requests from Vision Surgery Complications, Inc.).
That would sum things up nicely. You would be doing a great service by giving a voice to injured patients who
live in the shadows and saving future prospective patients who have no idea of the real risks of Lasik.
The dark truth about Lasik is also an excellent opportunity for an HBO documentary. For years the media has
missed the mark in countless 2-minute news segments and other ‘investigative’ reports on LASIK -- repeating
Lasik industry talking points, portraying injured patients as a small minority, and ignoring the science. Lasik
surgeons work together to protect their cash cow in the media. The science has been well documented
throughout this letter. Even if we were to agree with Lasik surgeons that 5% of Lasik patients are not satisfied,
then that would still be a significant number of unhappy patients. Combine that statistic with the fact that for
some of those patients, the results are devastating to the point of driving some to suicide, and you have a
health crisis for an unnecessary surgery. I am very much hoping that your unique show format can present the
facts without giving the “white coats” their sales spin for their own personal gain.
One final point is that while much of the discussion centers on Lasik, science shows that the cornea is a highly
sensitive organ and that all corrective eye surgeries carry risks that greatly outweigh the benefit of not wearing
glasses or contact lenses. The surgery is popular because the public is ill informed of these risks due to an inept
FDA and the fact that those who benefit from these surgeries are physicians whom society has taught us to
trust. Thank you for your consideration.
Please read below for reports written by patients injured by Lasik who have written
into the FDA MedWatch system:
1367931 - Suicidal ideation/depression - higher order aberrations, night vision disturbances - Lasik Eye
Surgery Ruined My Eyes. Lasik Surgeons Only Look At Eyes As A Cash Crop For Them To Harvest And Make
Money. They Didn'T Explain Or Tell Me About Any Of The Life Altering Problems Lasik Causes. They Know
That If They Did, No One Would Risk The Only Pair Of Eyes They Will Ever Have. The List Of Problems Lasik
Has Caused Me. Severe Glare Severe Starbursts Double Vision - Ghosting - Bad Vision In Low Light And
Darkness Halos Lights That Are Layered From The Light Source Dry Eye Severe Light Sensitivity Constant
Fluctuating Vision Depression, Anxiety And Thoughts Of Suicide.
1905783 – Suicidal ideation/depression - Vision Quality - Had Lasik Eye Surgery On (B)(6), 2010. Now Cannot
See To Do Any Of My Daily Tasks. Near And Mid-Vision Are Gone. I Only See Far Away. Was Only Told I
Would Need Readers For The Computer. Local Doctor Can'T Believe How Farsighted They Made Me. I Am
Preparing To Commit Suicide After I Get Me Affairs In Order For My Children. Only Those Who Have Gone
Through This Nightmare Understand The Guilt And Shame. You Spend Thousands Of Dollars And Have No
Recourse Whatsoever When The Outcome Is Bad. It Is A Great Scam For The Lasik Centers. Where On Earth
Could You Buy A Product And Then Not Have Any Recourse If It Does Not Work??? Please Put A Stop To This
Before Others Die Or Ruin Their Lives!!! Please Listen To Us!!!
2532690 - Suicidal ideation/depression – ectasia, higher order abherrations, night vision disturbances, eye
pain - Lasik Eye Surgery Has Destroyed My Quality Of Life, And Has Drastically And Irrevocably Slashed The
Time That I Have To "Live" Life. My Personal, Professional, Financial, Recreational, Social, Parental, And
Every Other Aspect Of Life That Has Been Decimated By Lasik. The Motivation Necessary To Live This Barren
Existence Is That I Do Not Destroy My Children'S Lives By Killing Myself. I Cannot Tell My Children From Their
Friends In My Own Home From More Than 4 Feet Away - Last Year It Was 13 Feet-; Extremely Limited Driving
Only During Daylight, And Non During Night; Unable To Walk Alone At Night Various Visual Disturbances Above
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And Beyond Extremely Poor Visual Acuity That Has Regressed Since Lasik, Such As: Starbursts; Halos; Ghosting,
Loss Of Contrast Sensitivity Resulting In Poor Depth Perception - I Trip On Steps Because I Cannot Tell Whether
They Are Steps Of Flat; Unable To Read Newspapers, Instructions, Menus, Ingredients, Dosing Instructions On
Medications, Bed Time Stories, Etc. - Thank God For The (B)(4).-; Ptsd Post Traumatic Stress Disorder- And
Resulting Anxiety And Depression; Hospitalizations For Suicidal Ideation; Financial Loss And Injustice Of A
Medical Malpractice Lawsuit That Deserves Its Own Documentary Detailing The Inadequacy Of The Justice
System, And The Need For Improved Laws Regarding Informed Consent, Statuses Of Limitations To File And
Trial The Case, Orders Of Protection, What Constitutes Evidence And What Is Mere Deception, Serious
Criminal Charges For Perjury, What Constitutes Double Jeopardy, Need For Objective Expert Witnesses, And
Orders Of Protection For Plaintiffs, And Their Attorneys And Expert Witnesses; Career Destroyed. Went From
Making (B)(6) A Year To Disability; Unable To Protect And Provide For My Family; Unable To Enjoy Television;
Unable To Play Most Sports Due To Poor Vision And The Astronomical Possibility Of Needing Cornea
Transplants If I Get Hit In The Eye With A Ball, A Finger, Etc; Severe Pain From Corneal Neuropathy From Lasik.
This Pain Is So Severe That I Said To My Wife, In Front Of My (B)(6) Daughter (B)(6), That "May Be I Should
Just Have My Eyes Removed, And Learn To Live As A Blind Person", At Which Time (B)(6) Became Hysterical
Crying, Because She Knew That I Wasn'T Kidding. This Eye Pain I Can Only Describe As Feeling Like Someone
Jammed An Ice Pick Into My Eye, And The Accompanying "Suicide Headache" Is Equally Severe And
Appropriately Named. There Really Is Hardly An Aspect Of Life That Has Not Been Scorched Due To Lasik. We
Have No Idea How Precious Our Eyes Are Until They Are Destroyed. I Was Told By One Psychologist That He
Considered My Ptsd Situation To Be "Worse Than That Of Someone Who Was Buried Alive Who Survived",
Because The Visual Reminders Of The Trauma That Continue To Be Trauma Are There Before My Eyes Every
Waking Moment Of My Life. Measurable Physical Damage To My Eyes From Lasik: Corneal Ectasia -Also Called
"Kerectasia" Or "Keratectasia"- - Lasik Induced Thinning And Weakening Of The Cornea, Causing The Cornea
Bulge Forward Due To The Intraocular Pressure Pressing Out On The Thinned Out Cornea. This Can Eventually
Burst The Cornea, Necessitating Corneal Transplants; Decentered Ablations - Causes Visual Distortions That
You Cannot Even Imagine Unless You Have Studied Optics; Ablation Zones That Are Too Small Relative To The
Pupil As It Dilates In Low Light Situations Resulting In The Same Visual Distortions Just Mentioned; Higher
Order Aberrations - I Imperfections In The Cornea -Peaks And Valleys Rather Than A Smooth Corneal SurfaceThat Prevent Light From Focusing Directly On The Retina Causing Visual Disturbances Like Starbursts, Halos,
Optical Illusions, Etc.; Decreased Contrast Sensitivity- Impairs Depth Perception; Corneal Neuropathy -Causes
Depilating Pain In Eye And Head. Neurologists Sometimes Refer To These Headaches As "Suicide Headaches"
Because The Severity Is So Great The Suffers Often Contemplate Suicide To Stop The Pain. Corneal Scarring;
Irregular Corneal Distortion; Irregular Astigmatism; Lasik Flap Which Never Heals - Allows The Stromal Layer Of
The Cornea To Be Exposed To Outside Elements Which Nature Had Never Intended; Additionally, Over The
Years My Visual Acuity Has Regressed To Almost It'S Pre-Lasik Point Of 20/80 And 20/200 - Lasik Doesn'T Even
Permanently Eliminate The Need For Glasses Or Contact Lenses. This Regression Takes Place Over Varying
Amounts Of Time For Different Pts, And Has Not Been Studied Because The Lasik Industry Knows Exactly
What It Will Find. The Unethical, Malignant, Narcissist Lasik Surgeons, Staff At (B)(6), Laser Manufactures,
And The Rest Of The Lasik Industry That Shamelessly Peddle And Perform This Barbaric And Always - 100%
Of The Time- Detrimental Procedure Should Have Their Licenses Revoked, Their Businesses Shut Down, And
Commercial, Civil, And Criminal Charges Should Be Brought Against Them. Class Action Lawsuits Should Be
Filed As Well. What Is The Fda Doing About This Issue That They Have Known About For A Decade? Why
Have They Not Responded To (B)(6) Formal Petition Calling For An End To Lasik? May The Laws Of Karma Be
Enforced On All Knowingly Involved. Lasik Injured Pts Families Are Significantly Affected. I'M Just Too Tired
To Write About This Now. They Should Have The Right To Sue The Lasik Industry For All That They Lost.
Some Close Family Members May Also Experience Ptsd Due To The Upheaval That Ensures From Lasik Injury.
This Document May Not Contain All Of My Complaints Regarding Lasik.
2680458 - Suicidal ideation/depression - dry eyes - I Had Lasik Surgery Completed On (B)(6) 2012, With The
Intralase Procedure … I Wore Contacts Comfortably For 20 Years Without Any Issues. I Met With Dr. (B)(6) For
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About 5 To 10 Minutes And Was Told I Was A Good Candidate. He Never Once, Nor Did His Staff, Tell Me
About The Risks And Side Effects Of Lasik Surgery. Since Then, I Have Gone To 3 Different Ophthalmologists, As
I Have Been In Pain; Discomfort To A Point That Put Me Into Major Depressions And Suffered From Ptsd. I Have
A Counselor And Psychiatrist To Get Me Through This. At One Point, I Didn'T Want To Live Anymore. The
Surgery Center Wiped Their Hands Clean Of The Procedure And Had Me Go To An Optometrist For All Of My
Post-Operative Care. The Surgery Center Has Not Been Compassionate Or Seems To Care How This Has
Affected My Life.
2578614 - Suicidal ideation/depression - higher order abherrations, night vision disturbances, corneal
erosions - I Have Had Two Lasik Surgeries Performed At (B)(6). … The Timeline For The Surgeries Is: (B)(6) 2010
… Lasik Procedures Induce Higher Order Aberrations. Many Pts Have 20/20 Visual Acuity, But Suffer From
Double Vision, Halos, Starbursts, Etc That Significantly Reduce Their Vision Quality. Advertising Success In
Terms Of Visual Acuity 20/20, 20/40, Etc Is Deceptive. I Was A High Risk Pt Likely To Experience Night Vision
Issues Including: Halos, Starbursts, And Multiple Vision Due To My High Degree Of Correction And Large Pupil
Size. I Was Not Informed Of This Until After The First Surgery. I Asked (B)(6) Directly If I Would Have Any Of The
Night Vision Issues Listed In The Informed Consent Because I Was Scared Of Having Damaged Night Vision As I
Spend A Significant Amount Of Time In Dim Or Dark Lighting Conditions. (B)(6), Od Informed Me That These
Side Effects Are No Longer An Issue With The Latest Procedures. … My Vision Was Not Stable At The Time I
Received The Second Surgery. My Vision Fluctuated Greatly Throughout Each Day. The Surgery Has Induced A
Significant Number Of Vitreous Floaters In Both Of My Eyes That Were Not Present Prior To The Surgeries. This
Side Effect Was Not Disclosed To Me Prior To Either Surgery. This Was Referred To As "The Fleas Of Everyone'S
Vision" By Dr (B)(6) When I Discussed The Issue With Him. Floaters Were Not The Fleas Of My Vision, But
Surgically Induced Damage To Both Of My Eyes. Both Surgeries Were Performed Within View Of The Lobby.
There Was A Seating Area Designated For Spectators. This Practice Gave The False Appearance That The
Surgery Was Safe And Without Risk. I Was Not Informed Prior To The First Surgery That The Corneal Flap Can
Be Easily Lifted During The First Two Years, And In Many Cases Lifted After Several Years. This One Sentence
Would Have Immediately Caused Me To Decline The Procedure. This Was Disclosed To Me Six Months After
The Initial Surgery, In The Second Consent Form Before My Re-Treatment. This Is Info That Could Reasonably
Cause A Large Population Of Potential Pts, Including Myself, To Decline Having The Surgery. The Corneal Flap
Does Not "Heal" In The Same Manner As The General Population Defines Healed. For Example, A Healed Cut
On One'S Arm After Surgery Cannot Be Easily Reopened For Years Following The Surgical Procedure. I Would
Not Have Accepted This Side Effect Under Any Circumstance.... I Can Provide Electronic Scans Of The Majority
Of My Medical Records Including Wavefront Measurements, Multiple Hospitalization Records For Attempted
Suicide And Depression, Informed Consent Forms From Both Lasik Procedures, Operative Reports For Both
Procedures, Etc. … Prior To Lasik, I Did Not Have Depression Or Any Other Mental Health Related Issues. I
Also Did Not Have Any Vision Problems Before Having Lasik.
1135383 - Suicidal ideation/depression - dry eyes - For The First 2 Weeks After Lasik, My Eyes Felt A Little
Dry, But Overall Good. However, Over The Next Few Weeks, The Dryness Kept Getting Worse. By Week 6, I
Had Severe Lasik Induced Nerve Damage Dry Eyes. My Eyes Were Bone Dry And The Pain Was Unbearable
For The First 10 Months Post-Lasik. I Could Feel The Pain With Every Blink Of Every Day. Even Closing My
Eyes Provided Minimal Relief. All The Eye Doctors Could Do Was Tell Me To Keep Using Artificial Tears, Put
Me On Restasis, And Put Plugs In My Puncta -The Drains Of The Eye-. These Things Provided Minimal Relief.
The Pain Was So Intense With So Little Relief From Existing Therapies That I Found Myself Researching
Suicide Options On The Internet. Prior To Lasik, I Was A Happy Family Man With A Good Job. To Think That I
Could Find Myself In This Type Of Position Because Of Lasik, An Unnecessary Fda Approved Procedure, Was
Beyond Belief. I Am Now Over 2 Years Post-Lasik And I Suffer From Senseless, Permanent Disabilities
Incurred From Lasik. There Are Many Things That I No Longer Can Do Such As Being In A Room With Moving
Air From Ceiling Fans, Heating Vents, Or Air Conditioning. I Can Only Work Limited Hours Due To The Chronic
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Post-Lasik Pain That I Endure. I Suffer From Chronic Eye Pain That Intensifies As The Day Goes On. I Would
Write More But I Don'T Think Anyone In The Fda Who Has Any Decision Making Authority Reads These
Reports Because If They Did, I Would Expect That They Would Feel A Shock To Their Conscience That The Fda
Continues To Allow People'S Eyes And Lives To Be Ruined By Lasik, A Senseless, Non-Medically Necessary
Procedure. I'Ve Heard Lasik Physicians Compare Lasik To Other Cosmetic Procedures. That'S Absurd! If
Somebody Has A Poor Outcome With Breast Augmentation, They Can Still Go To Work And/Or Drive At
Night. A Person'S Eyes Are Their Most Vital Sensory Organ. If You Damage A Person'S Eyes, You Damage That
Person In The Most Significant Way. While It'S Too Late For Me And Many Others, It'S Not Too Late For
Future Lasik Pts. I Request That The Fda Serve The Public That You Are Entrusted To Protect Rather Than
Serving The Lasik Industry.
1843552 - Suicidal ideation/depression - dry eyes, higher order abherrations, night vision disturbances,
floaters - Bilateral Intralase Lasik Performed In (B)(6) 2010, Using The Visx Customvue System. Pre Surgery
Prescription Od -3.14 Ds -0.32Dc, Os -3.12Ds -0.66Dc. Prior To Surgery, No Dry Eye Conditions, Excellent
Corrected Low Light Vision, No Appearance Of Floaters, No History Of Chronic Headaches, No History Of
Suicidal Thoughts. Three Months Post Surgery Complications - Pain In The Right Eye Accompanied By
Headaches, Dry Eyes, Appearance Of Many Dark Floaters, Starbursts And Halos Around Bright Light Sources In Both Low And Moderate Lighting Conditions-, Reduced Contrast Sensitivity - Reduced Ability To See Well
In Low Lighting-, Induced Astigmatism. These Conditions Result In Reduced Ability To Drive At Night,
Reduced Ability To Concentrate While On The Job, Reduced Ability To Participate In Activities And Everyday
Tasks In Low Light Settings; Increased Sensitivity To Bright Light, Increased Depression, Increased Anxiety.
2019933 - Suicide attempts - dry eyes, higher order abherrations, night vision disturbances, contrast
sensitivity - I Had Lasik Surgery On (B)(6) 2007. The Surgery Was Performed Within 4 Hrs Of My Initial Visit. I
Have Not Had Clear Vision Since The Day Of Surgery. My Problems Include Dry Eyes, Halos, Starbursts, No
Contrast Ability, Lack Of Peripheal Vision, Extreme Sensitivity To Light, And Now Bilateral Cataracts. I Was
Told At Every Visit That These Complications Would Resolve Over Time. Of Anything, My Symptoms Have
Become Worse. I Faced An Unk Amount Of Surgeries To Remove The Cataracts And I Am Concerned About
The Instability Of My Corneas, Which Have Been Damaged And Will At Some Point Require Corneal
Transplantation. At The Time Of My Surgery, I Was Earning In Excess Of (B)(6) Per Yr. Due To My Declining
Visual Ability And Debilitating Depression, I Am On (B)(6), Wherein I Receive A Monthly Stipend Of (B)(6). I
Have Attempted Suicide More Than 5 Times Since My Lasik.
1784677 - Suicidal ideation - dry eyes - patient is a neurologist - I Am Writing To Add To The Growing Reports
Of Long Term Adverse Effects Post Lasik Eye Surgery. In 2002, I Had Lasik With The Company Boots In Reading
In (B)(4). I Am A Neurologist And Should Probably Known Better But Believed The Consent Process Would Be
Similar To That Of Operations Carried Out In The (B)(4). Whilst I Accepted A Small Risk Of Visual Aberration Halos Etc- There Was Never At Any Time Mention Of A Risk Of Permanent Dry Eyes. I Suffered Severe Painful
Dry Eye Requiring Punctal Occlusion Immediately Post Op Which Lasted For Around 3 Months. I Had No
Preceding History Of Dry Eye And No Risk Factors -Male & Otherwise Well On No Medications-. Dry Eye
Symptoms Then Improved For Around 18 Months Before I Started Having Bouts Of Severe Eye Pain Lasting A
Few Days Or A Week Or Two. However, I Have Now Had Severe Dry Eye Pain Continuously For A Year Which
Has Been Devastating. I Am In The Medical Profession And Hence Seen Numerous Ophthalmologists And
Tried All The Usual Treatments Without Any Success -Plugs/Drops/Compresses/Omega-3/Steroid Drops Etc-.
The Symptoms Have Ruined My Quality Of Life At A Time When I Should Be Enjoying A New Family And
Successful Career. Instead I Have Become Clinically Depressed Requiring High Doses Of Anti-Depressants With No Prior History Of Any Depression- Due To Chronic -Eye- Pain. I Have Been Near Suicidal With The
Usual Issues -Guilt, Anger, Pain, Despair- And Cannot At Present See How I Can Continue To Function At
Work For Very Much Longer. Lasik Has Converted A Vigorous, Academically And Professionally Successful
Physician And Young Father Into A Depressed And Introverted Pt Who Fears For The Future And A Life Of
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Chronic Eye Pain. Whilst My Individual Case Is Of Itself Anecdotal That Is The Real Scandal Here. There
Appears Still No Robust Data On The Incidence Of Permanent Life Altering Adverse Events Post Lasik And It
Is Clearly Not In The Interest Of The Providers Of This Surgery To Collect This Data Or Make It Explicit.
However, It Would Be A Relatively Simple Audit To Conduct Given The Huge Numbers Of People Who Have
Under Gone This Surgery - A Random Mailing Of Only A Fraction Of A Percent Of Those Having Had Surgery
Over The Last 10 Yrs Would Provide Crucial Data On The True Incidence Of Permanent Adverse Events On
Which People Could Then Make Some Form Of An Informed Consent. The Second Issue Is The Importance Of
Requiring Consent To Highlight The Severity Of Potential Adverse Events, Even If These Are Rare. I For One And I Suspect Most/Many Others- Would Not Have Had The Procedure If I Had Known There Was Any
Chance Of A Chronic Pain Condition. Young Adults In The Prime Of Their Life Are Having Elective Surgery
With The Risk Of Potentially Life Altering Adverse Events For Which There Is Little Therapy. Post Lasik Dry
Eye Is A Completely Different Ball Park From Age Related Aqueous Deficiency Dry Eye -Both In Terms Of
Associated Pain And Relative Resistance To The Usual Therapies Despite What Ophthalmologists Involved
With Lasik Continue To Suggest. The Fact That Those Consenting Pts To Lasik Are Financially Motivated
Makes It Even More Important That Non-Biased Audit And Regulation Of This Surgery Is Carried Out. Sadly Is
Suspect Given Another 5-10 Yrs, We Will Have A Generation Of Refractive Surgery Pts Whose Life Has Been
De-Railed/Destroyed By Lasik Complications, A Generation Of Doctors And Companies That Have Profited
From The Unchecked/Unregulated Proliferation Of This Surgery And A Group Of Regulators Who Will Look
Back On The Fiasco Perhaps To Consider Whether The Pts Best Interests Have Really Been Served In The Way
This Surgery Has Been Introduced And Allowed To Escalate Unchecked And Unregulated. For Myself, I Do
Not Know What The Future Holds But A Single Uninformed Decision At The Age (B)(6) Has Wrecked My
Quality Of Life And I Urge You To Move To Collect Data On Longterm Risks Without Further Delay And To
Regulate/Standardise The Consent Process Of This Procedure In Light Of This Data. I Find It Hard To Believe
This Was Not A Requirement Of The Original Approval Process.
1036123 - Suicidal ideation - dry eyes - Severe Dry Eye Syndrome Pain, Unable To Work, Depression. Suicidal.
Dates Of Use: 2008. Diagnosis Or Reason For Use: Lasik.
2003547 - Suicide attempt – higher order abherrations & poor vision - I Had Lasik On (B)(6) 2010, At (B)(6).
The Surgery Was Performed By Dr. (B)(6) And The Ophthalmologist That Performed My Pre-Surgery Evaluation
Was Dr. (B)(6). The Day After The Procedure My Vision Was 20/70 According To The Snellen Acuity Test. My
Vision Was Extremely Blurry And Distorted. I Was Not Told What My Visual Acuity Was, And Was Allowed
To Drive For Over A Week Before Being Given A New Eye Glasses Prescription. Legal Vision In (B)(6) Is 20/30
Or 20/40. I Was Told Each Time By Dr. (B)(6) That I Am A Slow Healer And To Give It Time. I Was Suffering
From Multiple Images In Each Eye And Vision That Would Fluctuate Greatly Throughout Each Day. At Night,
The Halos, Starburst, And Multiple Images Were Much Worse. A Few Months Or So, After The First Lasik
Surgery I Consulted Dr (B)(6)- For A Second Opinion. He Spent Roughly Two Hours Working With Me And
Was Unable To Correct My Vision. His Words Were That The Outcome Was Not Catastrophic Like A Plane
Crash, But More Like The Landing Gear Just Broke Off. He Had Concerns That The Shape Of My Cornea Was
Changing Throughout The Day. I Made Two Additional Visits To Dr. (B)(6) About A Week Later, So He Could
Check My Eyes Twice Within The Same Day, Once In The Morning, And Once Later In The Day. My Vision Was
Fluctuating Throughout The Day. Dr (B)(6) Mentioned That Cross-Linking May Help And That A New Procedure
Would Possibly Be Available In 6-8 Months. Dr (B)(6) Also Mentioned That Higher Order Aberrations Were
Probably Responsible For My Poor Vision. Unsatisfied With Dr (B)(6) Opinion, I Sought A Third Opinion From
Another Ophthalmologist, Dr. (B)(6), Who Had Handled My Vision For About 4 Years Prior To Me Having
Lasik. He Too Was Unable To Correct My Vision And Mentioned That Higher Order Aberrations Were
Affecting My Vision. I Continued Follow Up Appointments With Dr. (B)(6) Due To Multiple Vision Issues. In
The First Half Of (B)(6) 2010, I Was Taken To The (B)(6) Hospital By My Father And Wife To Be Evaluated For
Depression The Night After I Almost Took My Own Life. I Was Taken To The (B)(6) Facility And Kept For The
Night For Observation And Released The Next Day. On (B)(6) 2010, I Had A Second Lasik Surgery Also
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Performed By Dr. (B)(6) As He Seemed Confident That He Could Correct My Vision. The Night Of This
Procedure, I Was Able To See Better Than I Had In The Previous 7 Months. The Next Day At My Follow Up
Appointment After The Bandage Contacts Were Removed My Vision Immediately Became Blurry. My Vision
Continued To Fluctuate Again After This Procedure And About 5 Days After The Enhancement Surgery,
Severe Double Vision Returned In My Right Eye And Multiple Images Have Since Reappeared In Both Eyes.
Prior To The Second Surgery, I Had Not Had Two Follow Up Appointments Where My Vision Was Stable. I Was
Unaware Of This At The Time I Had The Second Surgery. I Requested A Copy Of All Of My Records From Dr.
(B)(6) Office And My Wife Picked Them Up. The Records Were Incomplete And There Was No Mention Of
My Repeated Complaints Of Multiple Images, Halos, Starbursts, Etc In My File. In The Early Part Of (B)(6) I
Visited With A General Physician With My Wife To Seek Help For My Severe Depression. I Was Prescribed
Zoloft Which I Have Taken Daily Since Then With Little Relief. Near The End Of (B)(6) 2011, I Was Referred To
Dr (B)(6). He Explained That My Corneas Were Healthy And Not Scarred, But Due To The Amount Of Flattening
That Had Occurred Due To Correction Of My High Myopia (-7.50 Each Eye Contact Rx) That Stray Light Was
Causing The Issues I Was Seeing. In Addition To The Flattening Of My Corneas, The Size Of My Pupils Were
Also Contributing To My Vision Issues. He Told Me Not To Have Any Additional Surgeries. On (B)(6) 2011, I
Had Another Visit With Dr. (B)(6) Who Spent About 1.75 Hours And Was Also Unable To Correct My Vision.
He Too Mentioned That The Amount Of Flattening Of My Cornea Contributed To My Vision Issues. As Of
(B)(6) 2011, I Still Suffer From Poor, Frequently Fluctuating Vision During The Day. I See Multiple Images In
Each Eye And This Only Becomes Worse And More Apparent At Night. At Night I Suffer From Severe
Depression When I Am Out. The Starbursts Leave Rays Of Light That Project From Every Illuminated Object To
Me And Don'T Disappear Until The Original Light Source Has Been Obscured. When Cars Are Behind Me, The
Headlights In My Rearview Mirror Allow The Starbursts To Extend Beyond The Mirror And They Obstruct My
View Through My Windshield. Nighttime Issues Have Only Become Worse And Daytime Vision Is Poor As Well.
This Completely Unnecessary Surgery Has Robbed Me Of Everything That I Once Enjoyed. I Feel Terrible For
What My Wife Has Been Through As She Tries To Support Me Through This. I Feel Deceived By The Surgeon
And The Doctor Who Performed My Pre-Operative Evaluation. The Risks Were Minimized And The Fact That
The Surgery Was Performed In Plain View Of The Lobby Of Facility Gave The Appearance That This Was A
Trivial Surgery With No Real Risks. This Could Not Have Been Further From The Truth As I Have Found. This
Procedure Has Completely Ruined The Last 11 Months Of My Life And Left Me With Little To Look Forward
To Each Day. I Have Been Robbed Of Everything That I Once Enjoyed. I Cannot Even Relax And Watch Tv To
Escape. I Often Have Dreams About My Vision.
1393287 - Suicidal ideation - dry eyes - I Had Lasik Performed In 2008. The Procedure Caused Me To Wind Up
With Dry Eye Syndrome. I Was Told To Use Restasis, Take Biotear Gel Caps And Eat A Lot Of Omega 3 Foods.
I Have To Put Drops/Gel In My Eyes On An Hourly Basis Due To The Pain. I Can'T Use The Air Conditioning Or
Be Outside Because Of The Wind/Heat/Sun -I Live In Dry.- I Have Trouble Concentrating At Work Due To Pain.
I Work On A Computer All Day And I Have An Ac Return Directly Above Me. I Was Told My Life Would Change -I
Thought They Meant For The Better, Not Worse-. I Spend More Money Now Than I Did Before I Had The
Surgery. I Still Wear Glasses, The Only Difference Is I Am In Continual Pain And Have Limitations In My Daily
Routines. If I Had Been Properly Informed, I Would Have Said, No, Thank You. The Pain Is Not Worth Being
Able To See Better -And I Still Don'T Have 20/20-. I Had Almost A Minus Nine --9- Diopter In Both Eyes. Believe
Me In The Severest Of Pain, There Are Times When Thoughts Come To You Like I Don'T Want To Live Like
This. I Can'T Do This Any More. The Only Thing That Keeps Me Going Is That I Know In My Heart That God Is
Good And He Is Going To Help Me Overcome This. It'S Emotionally Frustrating Because There Isn'T Anything
Anyone Can Really Do.
Pupil Size
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1942173 - Night vision disturbances caused by large pupil size - I Underwent Lasik With The Visx Star 4 Laser
With Intralase. Now I Have Substantial Night Vision Disability That Is Getting Progressively Worse. I Was Never
A Good Candidate For The Procedure. The Fda'S Only Contraindication For The Procedure Is Not To Leave A
Corneal Residual Bed Less Than 250 Microns. I Started With A 500 Micron Cornea And Had A -8.00 Diopter
Correction That Left About A 280 Micron Corneal Bed. The Treating Surgeon And 2Nd Opinion Don'T Even
Want To Try An Enhancement Via Lasik But Via (B)(6) Which Risks Corneal Haze Because Of The Thinness Of
The Cornea. My Preop Pupil Size Was 8Mm. With The Correction Needed And My Pupil Size, My Night Vision
Disability Was Guaranteed. The Visx Laser Is Only Approved For An Optical Treatment Zone Of 6Mm With An
8Mm Blend. The Surgeons Make You Sign A Huge Consent Form That Guards Them Against Litigation But
They Otherwise Truly Fail To Inform The Pt Of Their Risks. The Fda Must Have More Stringent Criteria For
The Indications Of This Procedure. This Is An Elective Procedure But Truly A Medical Procedure. This Is Being
Treated Like A Cosmetic Procedure. There Are Too Many Eye Disorders That Are Being Created By
Overindicating High Risk Pts. The Public Needs To Be Protected. I Am A Physician And Surgeon. I Know That
It Does Not Matter What You Post On Your Web Site With Regard To Risks. Even A Relatively Safe Procedure
Can Be Risky If Performed On The Wrong Pt. Pt Selection Is Crucial. The Criteria For Undergoing Lasik Needs
To Be More Stringent With Regard To Pt Selection. Moreover, The Fda Is Too Focused On Visual Acuity With
Regard To Evaluating Success. There Are Many More Facets To Good Vision Than Acuity. Contrast Sensitivity
At Night And Night Vision Are Important Aspect Of Overall Vision.
2622822 – Night vision disturbances caused by large pupil size - I Had Customvue Wavefront Lasik, Also
Known As lasik With Intralase, Procedure Done By Dr (B)(6) On (B)(6) 2011. Six Months Later, I Still Have
Extremely Bad Night Blindness And Have Severe Impairment When Trying To Drive At Night. This Is A
Significant Impairment Because I Live In (B)(6) Where It Is Dark Much Of The Year. During My Exam, Dr (B)(6)'S
Assistant Measured My Pupils In A Dim Room, Not A Dark Room, At 8.0 Mm. The Assistant Asked Me How My
Night Vision Was, And I Replied That It Was Excellent. When I Asked If Having Large Pupils Would Be A
Problem, I Was Told That The (B)(6) Would Actually Improve My Night Vision. I Was Assured That None Of The
Scary Side Effects On The Informed Consent Forms Would Happen To Me, So I Signed And I Paid (B)(6) For
The Procedure, Plus The Cost Of The Exam, And Then Had The Surgery Two Days Later. The Procedure
Seemed To Go Fine, But I Immediately Noticed That I Had Severe Night Blindness After The Procedure. Six
Months Later It Still Has Not Gotten Better. When I Contacted Dr (B)(6) With My Concerns, He Said That He
Was Unable To Do Anything Unless He Examined Me. This Is Another Issue For Me Since I Live 800 Miles By Air
From (B)(6) In A (B)(6) Community And It Costs At Least (B)(6) For Me To Fly To (B)(6). Dr (B)(6) Said That He
Was Extremely Surprised That I Was Having Issues Because The (B)(4) Procedure "Improves Night Vision" In His
Words. On The Phone, Dr (B)(6) Explained That The Laser Treated 6.5 Mm Of My Cornea, And Then The
Wavefront Treated The Rest Of My Cornea All The Way Out To 8.0 Mm. He Also Said That His Records
Indicated My Pupils Were Measured At 7.5 Mm, Not 8.0 Mm. My Suspicion Is That My Pupil Dilates Far
Beyond 8.0 Mm At Night, And The Night Blindness Is Caused By An Undertreated Area On My Corneas. I Feel
That Dr (B)(6) Was Not Conservative Enough In His Treatment Of This Pt. Dr (B)(6)'S Suggestion Was To
Perform A Second Lasik Treatment On My Eyes. When I Said That I Was Afraid To Go Through That Again And
Couldn'T Afford It, Dr (B)(6) Said He Would Need To Examine Me. He Said We Could Possibly Look At
Prescribing Some Eyedrops To Constrict My Vision, Put Plugs In My Tear Ducts, Or Tinted Glasses For Night
Driving. He Thought Of Going Through The Procedure Again Is Terrifying. I Am Scare To Drive At Night And It Is
Making My Life Miserable. I Am Single And I Don'T Have Anybody Else To Drive Me Unless I Take A Taxi, Which
Is Not An Option Due To Cost. I Cannot Believe I Have To Deal With Vision Loss And The Loss Of My Mobility
And Freedom Because Of This Procedure. The Fda Should Pass Stricter Rules About Lasik Procedures On Pts
With Large Pupils.
1916830 – Night vision disturbances caused by large pupil size - I Had Lasik Twice Now. The First Time On
(B)(6) 2010. As A Result Of Lasik, I Had The Following Complications: Overcorrection Which Caused Me
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Constant Strain And Pain -Severe Loss Of Near Sight Due To Overcorrection -Extreme Starbursts And Halos At
Night -Loss Of Vision In Dim Settings Which Also Caused My Eyes To Strain -Daily Pain And Discomfort And
Pressure In Brow Area -Constant Blood Shot Eyes. I Underwent The Enhancement On (B)(6) 2010. While It
Seem To Have Helped With Some Issues, I Still Have: Daily Strain -Severe Starbursts And Halos At Night -Loss Of
Vision In Dim Settings. This Still Causes My Eyes To Strain And I Feel Daily Pressure In My Brow Area. I Also Feel
Pain In My Left Eye. It Is Difficult To Drive At Dusk And Night. My Pupils Are Very Large And I Was Never
Informed About Pupil Size. Nor Were My Eyes Ever Dilated. I Know This Is A Problem As Most Of My Issues
Are At Night And In Dim Lighting. Lasik Is Not Safe.
2536441 – Higher order abherrations caused by large pupils - Lasik Surgery. By (B)(6). Saw Him 10 Minutes
Before Procedure. Initial Exams Performed By Another Ophthalmologist. The Surgeon Stated I May Get Halos
With My Enlarged Pupils. I Was Not Warned Of Common Side Effects But About Major Complications Only.
2048252 – Night vision disturbances and large pupils - Lasik Surgery That Caused Decreased Night Vision And
Decreased Night Depth Perception. Read That Enlarged Pupils May Be Cause. I Was Never Advised This
Could Be A Problem With Lasik Surgery Although Eye Doctors Had Told Me I Have Enlarged Pupils. Eye
Doctors Also Advised That I Was A Good Candidate For Lasik Surgery And My Vision Since Is 20/15 And Has
Maybe Changed To 20/20. My Vision Before Was 20/450.
Additional suggested links:
Is Lasik safe? No! Read the facts!
Wonder why Lasik surgeons don't do surgery on one eye at a time? Shocking answer.
Lasik surgeons try to scare contact lens wearers into having LASIK
Over 1,000 people signed a petition to stop Lasik. Horrific testimonies
12 Questions to ask a LASIK surgeon before LASIK
Top Ten Reasons Not to Have Lasik Surgery
A sample of LASIK injuries reported to the FDA
Kind Regards,
Matt Kotsovolos
Director, Vision Surgery Complications, Inc.
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