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<TITLE>A Letter to the FDA about LASIK Complications</TITLE>
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<CENTER><B><FONT size=+2>~ The LASIK Letters ~</FONT></B></CENTER>
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<TABLE BORDER=0 CELLSPACING=0 CELLPADDING=0 COLS=6 WIDTH="100%" >
<TR>
<TD><FONT size=+1><A href="index-2.html">The Lunch-time LASIK Seminar</A></FONT></TD>
<TD><FONT size=+1>Letter to the FDA</FONT></TD>
<TD><FONT size=+1><A href="excerpts_a.html">Excerpts_A_1994 to 2000</A></FONT></TD>
<TD><FONT size=+1><A href="excerpts_b.html">Excerpts_B_2000 to 1994</A></FONT></TD>
<TD><FONT size=+1><A href="Common_Sense.pdf">THE Common Sense Article</A></FONT></TD>
<TD><FONT size=+1><A href="AIBS_DOD_Study.pdf">Department of Defense Study</A></FONT></TD>
</TR>
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<BR>
<P>Note: Looking for answers, I sent this letter to the FDA in September
1999. I changed the phone number to be current. The formatting
is a result of my lack of eye time ... I am transposing the letter from
"Word" format to html.
<P>Otherwise the letter is pretty much "original", as it was sent, way
back when.
<P>Roger Bratt
<P>Jan. 26, 2002
<P><B><FONT size=+2>Letter to the United States FDA about LASIK Complications</FONT></B>
<BR>
<HR WIDTH="100%">
<P>Roger E. Bratt * 1042-B N. El Camino Real, PMB #217
* Encinitas, CA 92024-1322 * <a class="__cf_email__" href="/cdn-cgi/l/email-protection"
data-cfemail="98caf7fffdeac7cbede8fdeafef7f7fcd8fde0fbf1ecfdb6fbf7f5">[email protected]</a><script
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<BR>
<P>Donna E. Shalala____________________________Ron Link
<BR>Secretary of Health and Human Services__________Executive Director
<BR>U.S. Department of Health & Human Services______Surgical Eyes Foundation
<BR>200 Independence Ave. S.W.__________________341 Lafayette Street #169
<BR>Washington, D.C. 20201______________________New York, NY 10012
<BR>
<P>Mr. Robert Palmisano________________________Al Gore
<BR>Chief Executive Officer_______________________Vice President of the
United States
<BR>Summit Technology__________________________1600 Pennsylvania Ave.
<BR>21 Hickory Drive____________________________Washington, D.C. 20500
<BR>Waltham, MA <a class="__cf_email__" href="/cdn-cgi/l/email-protection"
data-cfemail="28181a1c1d19777777777777777777777777777777777777777777777777775e414b4d06585
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<P>Dr. Susan Alpert____________________________William Jefferson Clinton
<BR>Director, Office of Device Evaluation_____________The President of
the United States of America
<BR>Food & Drug Administration___________________1600 Pennsylvania
Ave.
<BR>U.S. Department of Health & Human Services______Washington, D.C.
20500
<BR>200 Independence Ave. S.W.__________________ <a class="__cf_email__"
href="/cdn-cgi/l/email-protection"
data-cfemail="09797b6c7a606d6c677d497e61607d6c61667c7a6c276e667f">[email protected]</a><sc
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<BR>Washington, D.C. 20201
<P>Hon. Senator Edward M. Kennedy_______________Mrs. Hillary Rodham Clinton
<BR>315 Russell Senate Office Building________________c/o The President
of the United States of America
<BR>United States Senate__________________________1600 Pennsylvania Ave.
<BR>Washington, DC 20510________________________Washington, D.C. 20500
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<P>Mrs. Tipper Gore
<BR>c/o Vice President of the United States
<BR>1600 Pennsylvania Ave.
<BR>Washington, D.C. 20500
<BR><a class="__cf_email__" href="/cdn-cgi/l/email-protection"
data-cfemail="8fe2fdfca1e8e0fdeacff8e7e6fbeae7e0fafceaa1e8e0f9">[email protected]</a><script
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*/</script>_________________________________________September
19, 1999
<BR>
<P>Ladies and Gentlemen:
<P>I am writing regarding a subject of great mutual interest.
<P>The general subject is the miracles and supposed miracles of modern
medical technology. The
<BR>specific subject is LASIK, Laser Assisted In-Situ Keratomileusis.
<P>I am a LASIK patient. My own LASIK surgery was performed on both
eyes on August 14, 1998 by Dr. Michael Gordon at the Vision Surgery &
Laser Center in San Diego, California.
<P>I queried one of Dr. Gordon's assistants about what machine was used
during my surgery. The answer I remember receiving is a "Summit Apex
Plus."
<P>Since that time, my life has been a nightmare of pain (in my left eye)
& esotropia (in my left eye). The esotropia results in double
vision, and the foreign body sensation is akin to a dirty contact lens
permanently implanted on (stuck to) the cornea of my left eye. The
esotropia was diagnosed about 3 months after the surgery. The foreign-body
sensation in my left eye has been a permanent fixture in my life since
the time of the operation.
<P>Also accompanying these symptoms has been the loss of clear eagle-eyed
near-sighted vision. The Doctor spoke a lot about presbyopia during
pre-op consultations. It appears to me that LASIK "burns away" your
near-sighted vision and that the symptoms are similar to presbyopia.
Strange that my own personal symptoms of presbyopia should emerge immediately
after the LASIK procedure.
<P>In terms of day to day living, I was shocked to find that I couldn't
read the big block letters at the opening of the recent Phantom Menace
movie, without closing one eye. I recall seeing "Return of the Jedi"
in 1983 when I was wearing glasses, and having no such problems.
This is an example of the double vision at work, and my frequent remedy
-- to close one eye.
<P>Whether you call it "loss of eagle-eyed near-sighted vision" or "sudden
onset of presbyopia symptoms immediately following LASIK procedure", there
is another example which brings it home regarding the aspect of my vision
that I have lost. Before the LASIK I had about 28 years of metal-working
experience. I could look at an 0-80 screw, the size you might use
in a watch case, and clearly see the fine detail of the helical threads.
A situation arose at work recently where I needed to make a quick modification
on a part in a lathe. This involves guiding the head of a carbide
tool safely to within .001 inch of a given destination. I had to
let someone else do the work.
<P>Whether focussing on the threads of a small shoulder screw or using
a carbide tool to increase the length of the shoulder, before the LASIK
operation these were pleasurable tasks, involving the ability to focus
effortlessly on very small objects. I no longer have that ability.
<P>I call this loss of near-sighted vision, permanent foreign-body sensation,
and double-vision an impairment of vision. I am hungry for answers.
<P>I have enclosed color copies of three photos. One photo shows
20 weeks worth of eyedrops. I have a persistent foreign body sensation
in my left eye that has not subsided since the surgery. Every time
I put in eyedrops, it provides brief, fleeting relief, and then a return
to the dual challenge of blepharitis and dry eye syndrome, with which I
have been recently diagnosed by the doctors at my HMO.
<P>The strange thing is, before the surgery, I never used eyedrops, except
when I was experimenting with contact lens'. I think it is safe to
say that I was contact lens intolerant. Therefore, I stuck with my
eyeglasses. Then, I met Dr. Gordon, and I got the impression that
I could see clearly without glasses, with no immediate loss in near-sighted
vision, without pain, as safely as having a cavity filled at a dentist.
<P>It is my understanding of product liability law that there exists a
rule known as the "learned intermediary rule." i.e., though a machine
such as the Summit Apex Plus could be said to have two users, the doctor
and the patient, the manufacturer of the machine is considered by the law
to have one user -- the doctor. It is incumbent upon the doctor to
explain the risks associated with the medical procedure to the patient.
<P>It is my suspicion that the word "learned" also carries with it the
essence of integrity.
<P>Perhaps you can help me. Did the operation performed by Dr. Gordon
using the Summit Apex Plus cause my ocular surface disease to manifest
?? It appears to me that the operation has had this effect.
<P>Although I have spent perhaps 3 hours in Dr. Gordon's company over two
years, I can not recall any time when he has acknowledged that I have blepharitis.
However, after five minutes with two different HMO ophthalmologists, I
have been told the same thing ... "You have blepharitis." Is it possible
that the Summit Apex Plus caused my blepharitis ?? Did it exist pre-operatively
... is it possible that Dr. Gordon neglected to diagnose and disclose it
??
<P>Based on my contact lens intolerance prior to the LASIK procedure, and
the quickness of the HMO doctors to diagnose this condition, I conclude
that I had ocular surface disease before the procedure, but was asymptomatic,
except when I tried to wear contact lens'. Then, I underwent the
LASIK procedure, and the symptoms manifested assertively in my left eye.
<P>I am afraid a similar scenario may have occurred relative to my esotropia.
My Mom, who took the enclosed photo-with-eyeglasses in 1997, recently took
one look at it and said, "yes, you're a little cross-eyed in this photo."
What do you think ?? Do you think the LASIK procedure caused
my esotropia to
<BR>manifest, or that it existed pre-operatively ?? I understand
that conventional eyeglass' contain a limited
<BR>prism correction. Is it possible that my esotropia pre-existed
the LASIK operation, that it was not diagnosed and disclosed, and that
the primary symptom of the esotropia -- double-vision -- manifested only
after the operation, when my eyes were functioning without the prosthetic
aid of eyeglasses ??
<P>Of course, before the LASIK, my right eye was my dominant eye.
After the LASIK, my slightly-crossed
<BR>left eye has the better visual acuity. Perhaps this shift of
visual acuity away from the dominant eye is an important factor in my vision
complications.
<P>In any case, I note two references to "strabismus" in the FDA literature.
On page 178 of the Second Day of the Ophthalmic Devices Panel convened
on October 21, 1997, there is a fascinating exchange between Drs. Stulting
and Macsai ...
<P>Dr. Stulting: Well, they don't have it. They have latent
strabismus. They have -<BR>Dr. Macsai: But this is fine. They are at risk for developing
strabismus if you treat them.
<P>The URL for this section of the Proceedings is ...
<BR>http://www.fda.gov/ohrms/dockets/ac/97/transcpt/3344t2.pdf
<BR>Note ... it is in Adobe Acrobat file format.
<P>Well, if LASIK can cause strabismus, I think it's time to get the word
out.
<P>Contrastingly, in a paper entitled, "Discussion Points for Expansion
of the "Checklist of Information Usually Submitted in an Investigational
Device Exemption (IDE) Application for Refractive Surgery Lasers" Draft
Document", on page 7 there is an Examination Schedule and list of Exclusion
Criteria.
<BR>Down at the bottom of the table is a row entitled "Subjects at risk
for developing strabismus posttreatment." For persons with "Low to
Moderate" and "High" Myopia, with and without astigmatism -- I would characterize
myself as being moderately myopic with minimal astigmatism pre-op -- the
box is checked NA, for Not Applicable. The URL for this paper is
...
<BR>http://www.fda.gov/cdrh/ode/rslaschk.html
<P>Based on my own experience, the Stulting/Macsai interchange, and the
experience of "Phil", who has experienced bi-lateral strabismus following
multiple laser ablations, I think that box on that page of the Checklist
should have a "Check" for "Applicable", not NA.
<P>In other words, the evidence suggests that ocular muscle dysfunction
is an occasional side effect of laser corneal ablation, and the public
-- the consumers -- deserve to know thiss.
<P>I suggest that it is both wise and ethical for the manufacturers of
ophthalmic laser workstations to put BIG warning labels on their workstations,
describing all risks alliterated to in the medical literature, the FDA
clinical trials, the Summit and VISX SEC filings, and the Surgical Eyes
website. If a doctor as experienced in refractive surgery as Doctor
Gordon can have patients with the results I am experiencing, then ... I
don't know what to say.
<P>Hitherto, the medical suggestions that I have received have been two-fold:
to help me deal with the foreign-body sensation (pain) in my left eye following
the LASIK surgery, and to help correct the esotropia in my left eye.
For the former, it has been recommended that I consider wearing a transparent
shield over my left eye, to increase the humidity. And/or buy a humidifier,
and/or move to Florida.
<P>For the latter, eyeglasses with a prism correction are apparently a
logical avenue to explore. The one pair that I have had prepared
thus far, specifically for near-sighted vision to get me back to being
a 12-hour-a-day computer nerd, did not achieve the objective. It
was more fatiguing than the eye-patch that I now use to achieve clear vision.
<P>In fact, in 1990 I worked for 3 months as an engineering consultant
for Phoenix Laser Systems, with a team of about 60 technical contributors
charged with the task of developing an ophthalmological surgical workstation.
My responsibilities included the finite element modelling and analysis
of the optics for resonances, and the 3D modelling of a device used to
measure corneal topography. I was laid off a month before what I
guess to be their final "downsizing."
<P>Before my LASIK surgery, I was a bonafide 12-hour-a-day computer nerd.
Now, after 7 hours on the computer, my eyes and brain are fatigued.
This is not satisfactory.
<P>I am 41 years old.
<P>I presently have a very strong need to understand what has happened
to my vision. You are more than welcome to contact me at this email address -- <a class="__cf_email__"
href="/cdn-cgi/l/email-protection"
data-cfemail="fd8f929a988f989f8f9c8989bd849c959292d39e9290d3">[email protected]</a><script
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<P>I have enclosed copies of my medical records, as recorded by Dr. Gordon,
along with recent color topographical charts. If you can suggest
a doctor who can help me understand what has happened to my vision, I welcome
the suggestion. I do not relish the idea of wearing a transparent
goggle with prism correction over my left eye for the rest of my life.
<P>Anything you can do to help me develop a clear picture of what has happened
to my vision is most appreciated.
<P>Yours truly,
<P>Most Sincerely,
<P>~ Roger ~
<P>Roger E. Bratt
<P>
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<BR><FONT size=+1>Copyright Roger Erland Bratt 1999-2002</FONT>
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