Download Meta 2 - GP Specialists

PACKAGE INSERT
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.
CAUTION: Federal Law· Restricts This Device to Sale by or on the Order of
a Licensed Practitioner.
BioCurve, Inc. SOFT AND BioCurve, Inc. Custom SOFT TORIC
BioCurve, Inc. SOFT FW AND BioCurve, Inc. SOFT TORIC FW
(Methafilcon A)
Clear and Handling Tinted Hydrophilic Contact Lenses
Spherical Lenses and Aspherical Lenses for:
1. Myopia
2. Hyperopia
3. Astigmatic (Toric) Lenses to Correct Astigmatism
DESCRIPTION:
The BioCurve, Inc. SOFT , and the BioCurve, Inc. SOFT FW (methafilcon
A) hydrophilic contact lens is available as a spherical lens and as an
astigmatic (toric) lens, BioCurve, Inc. SOFT TORIC and the BioCurve, Inc.
SOFT TORIC FW. The lens material Hydrofilcon (methafilcon A) is a
polymer of HEMA (hydroxyethylmethacrylate) and is available in both clear
and a tinted (FD&C Green #6) version for ease of handling. The BioCurve,
Inc. SOFT AND BioCurve, Inc. SOFT FW Contact Lens is a hemispherical
shell of the following dimensions:
1. Standard Diameter: 14.5mm
2. Center Thickness, for Minus Lens: 0.04 mm to 0.08mm
3. Center Thickness, for Plus Lens: 0.08mm to 0.25 mm
4. Standard Base Curve: 8.4mm, 8.6mm, 8.8mm
5. Standard Powers: -20.00 Diopters to +20.00 Diopters
6. Standard Diameter of Optic Zone: 8.Omm to 8.5mm
The BioCurve, Inc. SOFT TORIC AND THE BioCurve, Inc. SOFT TORIC
FW Contact Lens is a hemispherical shell of the following dimensions:
1. Standard Diameter: 14.5mm
2. Center Thickness: 0. 04mm to 0.25 mm
3. Standard Base Curves: , 8.6mm, 8.8mm,9.0mm
4. Standard Spherical Powers: -20.00 to +10.00 Diopters
5. Standard Cylindrical Powers: 0.75 Diopters to 6.50 Diopters
6. Toric Optic Zone: 7.5mm to 8.00mm
The physical/optical properties of the lenses are:
1. Specific Gravity: 1.09
2. Refractive Index: 1.415
3. Light Transmittance Clear: 98.8%
4. Light Transmittance Handling Tinted: 93%
5. Surface Characteristic: Hydrophilic
6. Water Content: 55% water
7. Oxygen Transmissibility: 31.3 x 10-9 (cm=/sec) ml O2/ML x mmHg at
25°C, as measured by Schema Versatae Model 920 connected to a
polarographic cell
ACTIONS:
In its hydrated state, The BioCurve, Inc. SOFT , and the BioCurve, Inc.
SOFT FW Contact Lens. when placed on the cornea, acts as a retracting
medium to focus light rays on the retina. The BioCurve, Inc. SOFT TORIC
and BioCurve, Inc. SOFT TORIC FW lenses provides a more even surface
over the highly uneven astigmatic cornea and thus helps to focus light rays
on the retina.
INDICATIONS:
The BioCurve, Inc. SOFT AND BioCurve, Inc. Custom SOFT TORIC
Contact Lenses are indicated for daily wear for the correction of refractive
ametropia (myopia, hyperopia and astigmatism) in aphakic and/or nonaphakic persons with non-diseased eyes. The lens may be disinfected using a
chemical disinfection system only.
The BioCurve, Inc. SOFT FW and BioCurve, Inc. SOFT TORIC FW
Contact Lenses are indicated for daily wear or extended wear by non-aphakic
persons with non-diseased eyes. The lenses are for the correction of
refractive ametropia (myopia, hyperopia, and astigmatism). The spherical
lens may be worn by persons with up to 1.50 diopters of astigmatism that does not
interfere with visual acuity; the toric lens corrects astigmatism of 6.5 diopters or less.
Lenses prescribed for daily wear should not be worn while sleeping. Lenses prescribed
for extended wear may be worn from 1-7 days between removals for cleaning, rinsing,
and disinfection or replacement, as recommended by the eyecare practitioner: Each time
the lenses are removed from the eye they must be cleaned, rinsed, and disinfected. The
lenses may be disinfected using a chemical disinfection system only.
CONTRAINDICATIONS:
DO NOT USE the BioCurve, Inc. SOFT ,BioCurve, Inc. SOFT TORIC,BioCurve, Inc.
SOFT FW, and the BioCurve, Inc. SOFT TORIC FW Contact Lens when any of the
following conditions exist:
1. Acute and sub acute inflammation or infection of the anterior chamber of the eye.
2. Any eye disease, injury, or abnormality that affects the cornea, conjunctiva, or
eyelids
3. Severe insufficiency of lacrimal secretion (dry eyes).
4. Corneal hypoesthesia (reduced corneal sensitivity), any systemic disease that may
affect the eye or be exaggerated by wearing contact lenses.
5. Allergic reactions of ocular surfaces or adnexa that may be induced or exaggerated
by wearing contact lenses or use of contact lens solutions.
6. Allergy to any ingredient, such as mercury or Thimerosal, in a solution which is to
be used to care for the BioCurve, Inc. SOFT , BioCurve, Inc. SOFT TORIC,
BioCurve, Inc. SOFT FW or BioCurve, Inc. SOFT TORIC FW Contact Lens.
Any active corneal infection (bacterial, fungal, or viral).
7. If eyes become red or irritated.
WARNINGS:
Patients should be advised of the following warnings pertaining to contact lens wear:
1.
2.
3.
4.
Problems with contact lenses and lens care products could result in serious injury to
the eye. It is essential that patients follow their eyecare practitioner’s direction and
all labeling instructions for proper use of lenses and lens care products, including
the lens vials. Eye problems, including corneal ulcers, can develop rapidly and lead
to loss of vision.
The risk of ulcerative keratitis has been shown to be greater among users of
extended wear lenses than among users of daily wear lenses. The risk among
extended wear lens users increases with the number of consecutive days that the
lenses are worn between removals, beginning with the first overnight use. This risk
can be reduced by carefully following directions for routine lens care, including
cleaning of the lens vials.
Studies have shown that contact lens wearers who are smokers have a higher
incidence of adverse reactions than nonsmokers.
If a patient experiences eye discomfort, excessive tearing, vision changes, or
redness of the eye, the patient should be instructed to immediately remove lenses
and promptly contact his or her eyecare practitioner.
PRECAUTIONS:
Special Precautions for Eyecare Practitioners:
1.
2.
3.
4.
5.
6.
Due to the small number of patients enrolled in clinical investigation of lenses, all
refractive powers, design configurations, or lens parameters available in the lens
material are not evaluated in significant numbers. Consequently, when selecting an
appropriate lens design and parameters, the eyecare practitioner should consider all
characteristics of the lens that can affect lens performance and ocular health,
including oxygen permeability, wettability, central and peripheral thickness, and
optic zone diameter.
The potential impact of these factors on the patient’s ocular health should be
carefully weighed against the patient’s need for refractive correction; therefore, the
continuing ocular health of the patient and lens performance on the eye should be
carefully monitored by the prescribing eyecare practitioner.
Aphakic patients should not be fitted with BioCurve, Inc. SOFT or BioCurve, Inc.
SOFT TORIC Contact Lenses until the determination is made that the eye has
healed completely.
Fluorescein, a yellow dye, should not be used while the lenses are on the eyes. The
lenses absorb this dye and becomes discolored. Whenever fluorescein is used in
eyes, the eyes should be flushed with a sterile saline solution that is recommended
for in-eye use.
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 or her.
Eyecare practitioners should instruct the patient to remove the lenses immediately
if the eye becomes red or irritated.
Eyecare practitioners should carefully instruct patients about the following care regimen
and safety precautions:
1. Different solutions cannot always be used together, and not all solutions are safe for
use with all lenses. Use only recommended solutions.
2. Never use solutions recommended for conventional hard contact lenses only.
3. Chemical disinfection solutions should not be used with heat unless specifically
indicated on product labeling for use in both heat and chemical disinfection.
4. Always use fresh unexpired lens care solutions.
5. Always follow directions in the package inserts for the use of contact lens solutions.
6. Use only a chemical lens care system. Use of a heat or thermal care system may
cause the The BioCurve, Inc. SOFT , BioCurve, Inc. SOFT TORIC, BioCurve, Inc.
SOFT FW or BioCurve, Inc. SOFT TORIC FW Contact Lenses to become cloudy.
7. Use only chemical solutions that DO NOT contain sorbic acid or potassium sorbate.
These ingredients will cause the lens material to discolor.
8. Sterile unpreserved solutions, when used, should be discarded after the time
specified in the labeling directions.
9. Do not use saliva or anything other than the recommended solutions for lubricating
or wetting lenses.
10. Always keep the lenses completely immersed in the recommended storage solution
when the lenses are not being worn (stored). Follow the lens care directions for Care
for a Dried Out (Dehydrated) Lens if lens surface does become dried out.
11. If the lens sticks (stops moving) on the eye, follow the recommended directions on
Care for a Sticking Lens. The lens should move freely on the eye for the continued
health of the eye. If nonmovement of the lens continues, the patient should be
instructed to immediately consult his or her eyecare practitioner.
12. Always wash and rinse hands before handling lenses. Do not get cosmetics, lotions,
soaps, creams, deodorants, or sprays in the eyes or on the lenses. It is best to put on
lenses before putting on makeup: Water-base cosmetics are less likely to damage
lenses than oil-base products.
13. 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.
14. Carefully follow the handling, insertion, removal, cleaning, disinfecting, storing and
wearing instructions in the Patient Instructions for the BioCurve, Inc. SOFT and
BioCurve, Inc. SOFT FW and BioCurve, Inc. SOFT TORIC and BioCurve, Inc.
SOFT TORIC FW Contact Lens and those prescribed by the eyecare practitioner.
15. Never wear lenses beyond the period recommended by the eyecare practitioner
16. If aerosol products such as hair spray are used while wearing lenses, exercise
caution and keep eyes closed until the spray has settled.
17. Always handle lenses carefully and avoid dropping them.
18. Avoid all harmful or irritating vapors and fumes while wearing lenses.
19. Ask the eyecare practitioner about wearing lenses during sporting activities.
20. Inform the doctor (health care practitioner) about being a contact lens wearer.
21. Never use tweezers or other tools to remove lenses from the lens container unless
specifically indicated for that use. Pour the lens into the hand.
22. Do not touch the lens with fingernails.
23. Always contact the eyecare practitioner before using any medicine in the eyes.
24. Always inform the employer of being a contact lens wearer. Some jobs may require
use of eye protection equipment or may require that the patient not wear contact
lenses.
25. 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 to a recommended
follow-up schedule.
ADVERSE REACTIONS:
The patient should be informed that the following problems may occur:
1. Eyes stinging, burning, itching (irritation), or other eye pain
2. Comfort is less than when lens was first placed on eye
3. Feeling that something is in the eye such as a foreign body or scratched area
4. Excessive watering (tearing) of the eyes
5. Unusual eye secretions
6. Redness of the eyes
7. Reduced sharpness of vision (poor visual acuity)
8. Blurred vision, rainbows, or halos around objects
9. Sensitivity to light (photophobia)
10. Dry eyes
If the patient notices any of the above. he or she should be instructed to:
1. Immediately remove lenses.
2. If the discomfort or problem stops, then look closely at the lens. If the lens is in any
way damaged, do not put the lens back on the eye. Place the lens in the vial or
storage case and contact the eyecare practitioner.
3.
If the lens has dirt, an eyelash, or other foreign body on it, or the
problem stops and the lens appears undamaged, the patient should
thoroughly clean, rinse, and disinfect the lenses; then reinsert them.
After reinsertion, if the problem continues, the patient should
immediately remove the lenses and consult the eyecare practitioner.
4. When any of the above problems occur, a serious condition such as
infection. corneal ulcer, neovascularization, or iritis may be present. The
patient should be instructed to keep the lens off the eye and seek
immediate professional identification of the problem and prompt
treatment to avoid serious eye damage.
FITTING:
Conventional methods of fitting contact lenses apply to BioCurve, Inc. SOFT
, BioCurve, Inc. SOFT TORIC, BioCurve, Inc. SOFT FW and and
BioCurve, Inc. SOFT TORIC FW (methafilcon A) Contact Lenses. For a
detailed description of the fitting techniques, refer to the BioCurve, Inc.
SOFT and BioCurve, Inc. SOFT FW and BioCurve, Inc. SOFT TORIC and
BIOCURVE, INC. Custom SFOT TORIC FW Professional Fitting and
Information Guides, copies of which are available from:
BioCurve, Inc.
15980 Bernardo Center Drive
San Diego, California 92127
1-800-959-2020
4.
5.
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11.
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.
The BioCurve, Inc. SOFT AND BioCurve, Inc. Custom SOFT TORIC are
indicated for daily wear and BioCurve, Inc. SOFT FW and BioCurve, Inc.
SOFT TORIC FW Contact Lenses are indicated for daily and/or extended
wear. The suggested wearing time for these lenses is:
Maximum Wearing Times:
Day
1
2
3
4
5
6 and after (Daily Wear)
6 and after (Flexible Wear)
Maximum Continuous Hours
6
8
10
12
14
All Waking Hours
24 Extended Wear
Not every patient is able to wear a lens on an extended basis, even if able to
wear the same lens on a daily basis. Periodic checkups by an eye care
professional are extremely important, especially for patients on an extended
wear regime. With an extended wear regime there may be increased risks of
eye problems such as irritation, infection, corneal thickening and corneal
ulcers.
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. Lenses should be removed
for cleaning on the schedule recommended by the eye care practitioner [from
one (1) to seven (7 days). Each time the lenses are removed from the
wearer’s eyes, both surfaces of the lenses must be cleaned, rinsed, and
disinfected.
General Lens Care (To First Clean and Rinse, Then Disinfect Lenses)
Basic Instructions:
1. Always wash, rinse, and dry hands before handling contact lenses.
2. Always use fresh unexpired lens care solutions.
3. 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.
12.
13.
14.
Do not use saliva or anything other than the recommended solutions for lubricating
or rewetting lenses. Do not put lenses in the mouth.
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.
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.
The eyecare practitioner should recommend a care system that is appropriate for
the BioCurve, Inc. SOFT , BioCurve, Inc. SOFT TORIC, BioCurve, Inc. SOFT
FW and BioCurve, Inc. SOFT TORlC FW Contact Lenses. Each lens care product
contains specific directions for use and important safety information, which should
be read and carefully followed.
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.
Clean one lens first (always the same lens first to avoid mix-ups), 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 for the disinfecting and
storage solution instructions or an 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 solution. Replace a lens case at regular intervals as recommended by
the lens case manufacturer or your eyecare practitioner
Eyecare practitioners may recommend a lubricating/rewetting solution which can
be used to wet (lubricate) lenses while they are being worn to make them more
comfortable.
The BioCurve, Inc. SOFT , BioCurve, Inc. SOFT TORIC, BioCurve, Inc. SOFT
FW and BioCurve, Inc. SOFT TORlC FW Contact Lenses cannot be heat
(thermally) disinfected.
CHEMICAL DISINFECTION (including Hydrogen Peroxide)
1. Clean the contact lenses with a recommended cleaning solution and thoroughly
rinse them with a recommended rinsing solution.
2. After cleaning, to disinfect, carefully follow the instructions accompanying the
disinfecting solution in the care regimen recommended by the lens manufacturer or
the eyecare practitioner.
3. When using hydrogen peroxide lens care systems, lenses must be neutralized
before wearing. Follow the recommendations on the hydrogen peroxide system
labeling.
4. Thoroughly, rinse lenses with a fresh solution recommended for rinsing before
inserting and wearing; or follow the instructions on the disinfection solution
labeling.
5. Do not heat the disinfection solution and lenses.
6. Use only chemical solutions that DO NOT contain sorbic acid or potassum sorbate.
These ingredients will cause the lens material to discolor.
7. Leave the lenses in the unopened storage case until ready to put on the eyes.
8. 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 eyecare practitioner.
CARE FOR A DRIED OUT (DEHYDRATED) LENS:
Care for a Dried Out (Dehydrated) Lens:
If a soft, hydrophilic contact lens is exposed to air while off the eye, it may become dry
and brittle and need to be rehydrated. If the lens is adhering to a surface, apply sterile
saline before handling.
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 solutions as per the manufacturers labeling.
If after soaking, the lens does not become soft, if the surface remains dry, DO NOT USE
THE LENS UNLESS IT HAS BEEN EXAMINED BY YOUR EYECARE
PRACTITIONER.
CARE FOR A STICKING (NONMOVING) LENS:
If the lens sticks (stops moving), the patient should be instructed to apply a few of 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: FLUSH EYES IMMEDIATELY WITH TAP WATER AND REMOVE THE
LENS. IMMEDIATELY CONTACT THE EYECARE PRACTITIONER OR VISIT A
HOSPITAL EMERGENCY ROOM WITHOUT DELAY
HOW SUPPLIED:
Each BioCurve, Inc. SOFT , BioCurve, Inc. SOFT TORIC, BioCurve, Inc. SOFT FW
and/or BioCurve, Inc. SOFT TORIC FW (methafilcon A) lens is supplied sterile in a
glass vial containing sterile normal saline solution USP buffered with sodium bicarbonate
USP. The glass vial is 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:
All serious adverse experiences and adverse reactions observed in patients wearing
BioCurve, Inc. SOFT , BioCurve, Inc. SOFT TORIC, BioCurve, Inc. SOFT FW and
BioCurve, Inc. SOFT TORIC FW Contact Lenses should be reported to:
BioCurve, Inc.
15980 Bernardo Center Drive
San Diego, California 92127
1-800-959-2020
Printed: April 6, 2009