Download Gold 2 - GP Specialists

PACKAGE INSERT
9.
IMPORTANT - Please read carefully and keep this information for future
use. This package insert is intended for the eyecare practitioner, but should
be made available to patients upon request. The eyecare practitioner should
provide the patient with the patient instructions that pertain to the patient’s
prescribed lens.
WARNINGS :
Patients should be advised of the following warnings pertaining to contact lens wear:
If eyes become red or irritated
20. Do not touch contact lenses with the fingers or hands if the hands are not
free of foreign materials, as microscopic scratches of the lenses may
occur, causing distorted vision and/or injury to the eye.
21. Carefully follow the handling, insertion, removal, cleaning, disinfecting,
storing and wearing instructions in the Patient Instructions for the
1. Problems with contact lenses and lens care products could result in serious injury to the
BioCurve, Inc. Custom SOFT Contact Lens and those prescribed by the
eye. It is essential that patients follow their eyecare practitioner’s direction and all
eyecare practitioner.
22. Never wear lenses beyond the period recommended by the eyecare
labeling instructions for proper use of lenses and lens care products, including the lens
practitioner.
CAUTION: Federal Law Restricts This Device to Sale by or on the Order of
case. Eye problems, including corneal ulcers, can develop rapidly and lead to loss of
23. If aerosol products such as hair spray are used while wearing lenses,
a Licensed Practitioner.
vision.
exercise caution and keep eyes closed until the spray has settled.
2. Daily wear lenses are not indicated for overnight wear, and patients should be instructed
24. Always handle lenses carefully and avoid dropping them.
BioCurve, Inc. Custom SOFT (hioxifilcon A) Clear and Handling Tinted
not to wear lenses while sleeping. Clinical studies have shown that the risk of serious
25. Avoid all harmful or irritating vapors and fumes while wearing lenses.
Hydrophilic Contact Lenses Spherical and Aspherical Lenses for:
adverse reactions is increased when these lenses are worn overnight.
1. Myopia
3. Studies have shown that contact lens wearers who are smokers have a higher incidence of 26. Ask the eyecare practitioner about wearing lenses during sporting
activities.
2. Hyperopia
adverse reactions than nonsmokers.
27. Inform the doctor (health care practitioner) about being a contact lens
3. Aphakia
4. If a patient experiences eye discomfort, excessive tearing, vision changes, or redness of
wearer.
4. Astigmatic (Toric) Lenses to Correct Astigmatism
the eye, the patient should be instructed to immediately remove lenses and promptly
28. Never use tweezers or other tools to remove lenses from the lens container
contact his or her eyecare practitioner.
unless specifically indicated for that use. Pour the lens into the hand.
DESCRIPTION:
29. Do not touch the lens with fingernails.
PRECAUTIONS :
30. Always contact the eyecare practitioner before using any medicine in the
The BioCurve, Inc. Custom SOFT (hioxifilcon A) hydrophilic contact lens is
eyes.
available as a spherical and as an aspherical lens. The lens material,
Special Precautions for Eyecare Practitioners:
31. Always inform the employer of being a contact lens wearer. Some jobs
Hydrofilcon (hioxifilcon A), is a polymer of HEMA
1. Due to the small number of patients enrolled in clinical investigation of lenses, all
may require use of eye protection equipment or may require that the
(hydroxyethylmethacrylate) and is available in tint only (D&C Green #6)
refractive powers, design configurations, or lens parameters available in the lens material
patient not wear contact lenses.
version for ease of handling. The BioCurve, Inc. Custom SOFT Contact
are not evaluated in significant numbers. Consequently, when selecting an appropriate
Lens is a hemispherical shell of the following dimensions:
lens design and parameters, the eyecare practitioner should consider all characteristics of 32. As with any contact lens, follow-up visits are necessary to assure the
continuing health of the patient’s eyes. The patient should be instructed as
1. Diameter: Approximately 14.0, 14.5, 15.0
the lens that can affect lens performance and ocular health, including oxygen
to a recommended follow-up schedule.
2. Center Thickness, for Minus Lens: 0.06 mm to 0.15mm
permeability, wettability, central and peripheral thickness, and optic zone diameter.
3. Center Thickness, for Plus Lens: 0.14mm to 0.60 mm
2. The potential impact of these factors on the patient’s ocular health should be carefully
ADVERSE REACTIONS:
4. Base Curve: 8.2, 8.4, 8.6, 8.8, 9.0
weighed against the patient’s need for refractive correction; therefore, the continuing
5. Cylinder: -0.75 to -6.50
ocular health of the patient and lens performance on the eye should be carefully
The patient should be informed that the following problems may occur:
6. Powers: -20.00 Diopters to +10.00 Diopters
monitored by the prescribing eyecare practitioner.
7. Diameter of Optic Zone: Varies
3. Patients who wear aspheric contact lenses to correct presbyopia may not achieve the best 1. Eyes stinging, burning, itching (irritation), or other eye pain
2. Comfort is less than when lens was first placed on eye
corrected visual acuity for either far or near vision. Visual requirements vary with the
The physical/optical properties of the lenses are:
individual and should be considered when selecting the most appropriate type of lens for 3. Feeling that something is in the eye such as a foreign body or scratched
area
1. Refractive Index: 1.401
each patient.
2. Light Transmittance Handling Tinted: 87%
4. Aphakic patients should not be fitted with BioCurve, Inc. Custom SOFT Contact Lenses 4. Excessive watering (tearing) of the eyes
5. Unusual eye secretions
3. Surface Character: Hydrophilic
until the determination is made that the eye has healed completely.
4. Water Content: 59% water
5. Fluorescein, a yellow dye, should not be used while the lenses are on the eyes. The lenses 6. Redness of the eyes
7. Reduced sharpness of vision (poor visual acuity)
5. Oxygen Permeability: 20 x 1011 (cm2/sec) ml 02/ml x mmHg at
absorb this dye and become discolored. Whenever fluorescein is used in eyes, the eyes
8. Blurred vision, rainbows, or halos around objects
25°C, as measured by Schema Versatae Model 920 connected to a
should be flushed with a sterile saline solution that is recommended for in-eye use.
9. Sensitivity to light (photophobia)
polarographic cell
6. Before leaving the eyecare practitioner’s office, the patient should be able to promptly
remove lenses or should have someone else available who can remove the lenses for him 10. Dry eyes
ACTIONS :
or her.
If the patient notices any of the above, he or she should be instructed to:
7. Eyecare practitioners should instruct the patient to remove the lenses immediately if the
1. Immediately remove lenses.
In its hydrated state, the BioCurve, Inc. Custom SOFT Contact Lens, when
eye becomes red or irritated.
2. If the discomfort or problem stops, then look closely at the lens. If the lens
placed on the cornea, acts as a refracting medium to focus light rays on the
8. Eyecare practitioners should carefully instruct patients about the following care regimen
is in any way damaged, do not put the lens back on the eye. Place the lens
retina.
and safety precautions:
in the vial or storage case and contact the eyecare practitioner. If the lens
9. Different solutions cannot always be used together, and not all solutions are safe for use
has dirt, an eyelash, or other foreign body on it, or the problem stops and
INDICATIONS :
with all lenses. Use only recommended solutions.
the lens appears undamaged, the patient should thoroughly clean, rinse,
10. Never use solutions recommended for conventional contact lenses only.
and disinfect the lenses; then reinsert them. After reinsertion, if the
The BioCurve, Inc. Custom SOFT Contact Lenses are indicated for daily
11. Chemical disinfection solutions should not be used with heat unless specifically indicated
problem continues, the patient should immediately remove the lenses and
wear for the correction of refractive ametropia (myopia, hyperopia and
on product labeling for use in both heat and chemical disinfection.
consult the eyecare practitioner.
Astigmatism) in aphakic and/or non-aphakic persons with non-diseased eyes. 12. Always use fresh unexpired lens care solutions.
3. When any of the above problems occur, a serious condition such as
The lens may be disinfected using a chemical disinfection system only.
13. Always follow directions in the package inserts for the use of contact lens solutions.
infection, corneal ulcer, neovascularization, or iritis may be present. The
14. Use only a chemical lens care system. Use of a heat or thermal care system may cause the
patient should be instructed to keep the lens off the eye and seek
CONTRAINDICATIONS :
BioCurve, Inc. Custom SOFT Contact Lenses to become cloudy.
immediate professional identification of the problem and prompt
15. Sterile unpreserved solutions, when used, should be discarded after the time specified in
treatment to avoid serious eye damage.
DO NOT USE the BioCurve, Inc. Custom SOFT Contact Lens when any of
the labeling directions.
the following
16. Do not use saliva or anything other than the recommended solutions for lubricating or
conditions exist:
FITTING:
wetting lenses.
1. Acute and subacute inflammation or infection of the anterior chamber
17. Always keep the lenses completely immersed in the recommended storage solution when Conventional methods of fitting contact lenses apply to BioCurve, Inc. Custom
SOFT (hioxifilcon A) Contact Lenses. For a detailed description of the fitting
of the eye
the lenses are not being worn (stored). Follow the lens care directions for Care for a
techniques, refer to the BioCurve, Inc. Custom SOFT Professional Fitting and
2. Any eye disease, injury, or abnormality that affects the cornea,
Dried Out (Dehydrated) Lens if lens surface does become dried out.
Information Guides, copies of which are available from:
conjunctiva, or eyelids
18. If the lens sticks (stops moving) on the eye, follow the recommended directions on Care
3. Severe insufficiency of lacrimal secretion (dry eyes)
for a Sticking Lens. The lens should move freely on the eye for the continued health of
4. Corneal hypoesthesia (reduced corneal sensitivity), if not-aphakic
BioCurve, Inc.
the eye. If nonmovement of the lens continues, the patient should be instructed to
5. Any systemic disease that may affect the eye or be exaggerated by
15980 Bernardo Center Drive
immediately consult his or her eyecare practitioner.
wearing contact lenses
San Diego, California 92127
19. Always wash and rinse hands before handling lenses. Do not get cosmetics, lotions,
6. Allergic reactions of ocular surfaces or adnexa that may be induced or
1-800-959-2020
soaps, creams, deodorants, or sprays in the eyes or on the lenses. It is best to put on lenses
exaggerated by wearing contact lenses or use of contact lens solutions
before putting on makeup. Water-base cosmetics are less likely to damage lenses than oil7. Allergy to any ingredient, such as mercury or Thimerosal, in a solution
base products.
which is to be used to care for the BioCurve, Inc. Custom SOFT
8. Any active corneal infection (bacterial, fungal, or viral)
WEARING SCHEDULE:
The wearing and replacement schedules should be determined by the eyecare
practitioner. Patients tend to overwear the lenses initially. The eyecare
practitioner should emphasize the importance of adhering to the initial
maximum wearing schedule. Regular checkups, as determined by the eyecare
practitioner, are also extremely important.
2.
The BioCurve, Inc. Custom SOFT Contact Lenses are indicated for daily
wear. The maximum suggested wearing time for these lenses is:
Day
Continuous Hours
1
6
2
8
3
10
4
12
5
14
All Waking Hours
6 and after
Studies have not been completed to show that the BioCurve, Inc. Custom
SOFT Contact Lens are safe to wear during sleep.
LENS CARE DIRECTIONS:
Eyecare practitioners should review with the patient lens care directions,
including both basic lens care information and specific instructions on the
lens care regimen recommended for the patient:
General Lens Care (To First Clean and Rinse, Then Disinfect Lenses)
1. Basic clean and rinse Instructions:
a. Always wash, rinse, and dry hands before handling contact lenses.
b. Always use fresh unexpired lens care solutions.
c. Use the recommended system of lens care, chemical (not heat) and
carefully follow instructions on solution labeling. Different
solutions cannot always be used together, and not all solutions are
safe for use with all lenses. Do not alternate or mix lens care
systems unless indicated on solution labeling.
d. Do not use saliva or anything other than the recommended
solutions for lubricating or rewetting lenses. Do not put lenses in
the mouth.
e. Lenses should be cleaned, rinsed, and disinfected each time they
are removed. Cleaning and rinsing are necessary to remove mucus
and film from the lens surface. Disinfecting is necessary to destroy
harmful germs.
f. Always remove, clean, rinse, enzyme (as recommended by the
eyecare practitioner) and disinfect lenses according to the schedule
prescribed by the eyecare practitioner. The use of an enzyme or
any cleaning solution does not substitute for disinfection.
g. The eyecare practitioner should recommend a care system that is
appropriate for the BioCurve, Inc. Custom SOFT Contact Lenses.
Each lens care product contains specific directions for use and
important safety information, which should be read and carefully
followed.
solution. Replace a lens case at regular intervals as recommended by the lens case
manufacturer or your eyecare practitioner.
All serious adverse experiences and adverse reactions observed in patients
Eyecare practitioners may recommend a lubricating/rewetting solution which can be wearing BioCurve, Inc. Custom SOFT Contact Lenses or experienced with the
used to wet (lubricate) lenses while they are being worn to make them more
lenses should be reported to:
comfortable.
m. BioCurve, Inc. Custom SOFT Contact Lenses cannot be heat (thermally)
BioCurve, Inc.
disinfected.
15980 Bernardo Center Drive
CHEMICAL DISINFECTION (including Hydrogen Peroxide)
San Diego, California 92127
a. Clean the contact lenses with a recommended cleaning solution and thoroughly rinse
1-800-959-2020
them with a recommended rinsing solution.
b. After cleaning, to disinfect, carefully follow the instructions accompanying the
Printed: April 6, 2009
disinfecting solution in the care regimen recommended by the lens manufacturer or
the eyecare practitioner.
c. When using hydrogen peroxide lens care systems, lenses must be neutralized before
wearing. Follow the recommendations on the hydrogen peroxide system labeling.
d. Thoroughly rinse lenses with a fresh solution recommended for rinsing before
inserting and wearing, or follow the instructions on the disinfection solution
labeling.
e. Do not heat the disinfection solution and lenses.
f. Leave the lenses in the unopened storage case until ready to put on the eyes.
l.
Caution: Lenses that are chemically disinfected may absorb ingredients from the disinfecting
solution which may be irritating to the eyes. A thorough rinse in fresh sterile saline solution
prior to placement on the eye should reduce the potential for irritation.
LENS DEPOSITS AND USE OF ENZYMATIC CLEANING PROCEDURE:
Enzyme cleaning may be recommended by the eyecare practitioner. Enzyme cleaning removes
protein deposits on the lens. These deposits cannot be removed with regular cleaners.
Removing protein deposits is important for the well-being of the patient’s lenses and eyes. If
these deposits are not removed, they can damage the lenses and cause irritation.
Enzyme cleaning does NOT replace routine cleaning and disinfecting. For enzyme cleaning,
the patient should carefully follow the instructions in the enzymatic cleaning labeling.
LENS CASE OR VIAL CLEANING AND MAINTENANCE:
Contact lens cases or vials can be a source of bacteria growth. Lens cases and vials should be
emptied, cleaned, rinsed with solutions recommended by the lens case or vial manufacturer,
and allowed to air dry. Lens cases should be replaced at regular intervals as recommended by
the lens case manufacturer or your eyecare practitioner.
CARE FOR A DRIED OUT (DEHYDRATED) LENS:
If for some reason, the lens dries out completely:
1. A minimum of handling is important as the lens is very brittle in the dehydrated state.
2. Carefully place lens in the case or vial and cover them with rinsing or storage solution for
a minimum of thirty minutes during which time they will become soft and flexible.
3. Then follow the cleaning, rinsing, and disinfecting procedures, including soaking the lens
in storage and disinfection solution as per the manufacturers labeling.
CARE FOR A STICKING [NONMOVING] LENS:
Note: Some solutions may have more than one function, which will be
indicated on the label. Read the label on the solution bottle, and follow
instructions.
h.
i.
j.
k.
Clean one lens first (always the same lens first to avoid mixups),
rinse the lens thoroughly with recommended saline or disinfecting
solution to remove the cleaning solution, mucus, and film from the
lens surface, and put that lens into the correct storage vial or
chamber of the lens storage case. Then repeat the procedure for the
second lens.
After cleaning, disinfect lenses using the system recommended by
the manufacturer and/or the eyecare practitioner.
To store lenses, disinfect and leave them in the closed/unopened
vial or case until ready to wear. If lenses are not to be used
immediately following disinfection, the patient should be
instructed to consult the package insert or the eyecare practitioner
for information on storage of lenses.
After removing the lenses from the vial or lens case, empty and
rinse the vial or lens storage case with solutions recommended by
the lens case manufacturer; then allow the vial or lens case to air
dry. When the vial or lens case is used again, refill it with storage
If the lens sticks, (stops moving,) the patient should be instructed to apply a few drops of the
recommended lubricating or rewetting solution directly to the eye and wait until the lens
begins to move freely on the eye before removing it. If nonmovement of the lens continues
after five minutes, the patient should immediately consult the eyecare practitioner.
EMERGENCIES :
The patient should be informed that if chemicals of any kind (household products, gardening
solutions, laboratory chemicals, etc.) are splashed into the eyes, the patient should: REMOVE
THE CONTACT LENS, FLUSH EYES IMMEDIATELY WITH TAP WATER AND
IMMEDIATELY CONTACT THE EYECARE PRACTITIONER OR VISIT A HOSPITAL
EMERGENCY ROOM WITHOUT DELAY.
HOW SUPPLIED:
Each BioCurve, Inc. Custom SOFT (hioxifilcon A) lens is supplied sterile in a glass vial
containing sterile normal saline solution USP, buffered with sodium bicarbonate USP. The
glass vial marked with the base curve, diopter power, diameter, lot number and expiration
date. In addition, the glass vial for a handling tinted lens has the tint color indicated.
REPORTING OF ADVERSE REACTIONS: