Bausch & Lomb PureVision Multi-Focal Contact Lenses - Manual (Page 3)

• While the great majority of patients successfully wear contact lenses,
extended wear of lenses also is reported to be associated with a higher
incidence and degree of epithelial microcycsts and infiltrates, and endothe-
lial polymegathism, which require consideration of discontinuation or restric-
tion of extended wear. The epithelial conditions are reversible upon
discontinuation of extended wear.
The long term risk of microbial keratitis has not been determined for this
lens. Post marketing studies are in progress.
The reversibility of endothelial effects of contact lens wear has not been
conclusively established. As a result, professionals views of extended wear-
ing times vary from not prescribing extended wear at all to prescribing
flexible wearing times from occasional overnight wear to prescribing extend-
ed wearing periods from 1 to 30 days with specified intervals of no lens
wear for certain patients, with follow-up visits, and with proper care
regimen.
• 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 eye care professional.
PRECAUTIONS:
Precautions for Eye Care Professionals:
• Due to the small number of patients enrolled in clinical investigation of
lenses, all refractive powers, design configurations, or lens parameters avail-
able in the lens material are not evaluated in significant numbers.
Consequently, when selecting an appropriate lens design and parameters,
the eye care professional should consider all characteristics of the lens that
can affect lens performance and ocular health, including oxygen permeabili-
ty, wettability, central and peripheral thickness, and optic zone diameter.
The oxygen transmissibility is below the established threshold required to
prevent overnight corneal edema for portions of the power range, including
some plus powers and some low minus power lenses.
1 In the U.S. clinical
study of the PureVision (spherical) lens, the rate of infiltrative keratitis was
found to be higher with higher lens powers (see Clinical Study section of the
package insert).
• 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 eye should be carefully monitored by the prescribing eye care profes-
sional.
• Patients who wear aspheric contact lenses, such as the Bausch & Lomb
PureVision Multi-Focal, to correct presbyopia may not achieve the best cor-
rected visual acuity for either far or near vision. Visual requirements vary
with the individual and should be considered when selecting the most
appropriate type of lens for each patient.
1 Holden BA, Mertz GW. Critical Oxygen Levels to Avoid Corneal Edema for
Daily and Extended Wear Contact Lenses. Invest Ophthalmol Vis Sci 25:1162, 1984.
• Eye care professionals should instruct the patient to REMOVE A LENS
IMMEDIATELY if an eye becomes red or irritated.
• Fluorescein, a yellow dye, should not be used while the lenses are on the
eyes. The lenses absorb this dye and become discolored. Whenever fluores-
cein is used in eyes, the eyes should be flushed with sterile saline solution
that is recommended for in-eye use.
• The patient should be instructed to always discard disposable lenses and
lenses worn on a frequent/planned replacement schedule after the recom-
mended wearing schedule prescribed by the eye care professional.
• Some patients will not be able to tolerate continuous wear even if able to
tolerate the same or another lens on a daily wear basis. Some patients
who are able to tolerate continuous wear will not be able to wear their
lenses continuously for 30 days. Patients should be carefully evaluated
for continuous wear prior to prescription and dispensing, and eye care
professionals should conduct early and frequent follow-up examination
to determine ocular response to continuous wear.
• 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.
• Aphakic patients should not be fitted with PureVision Contact Lenses
until the determination is made that the eye has healed completely.
Eye care professionals should carefully instruct patients about the following
lens care and safety precautions. It is strongly recommended that patients
be provided with a copy of the PureVision Multi-Focal Patient Information
Booklet available from BAUSCH & LOMB and understand its contents prior
to dispensing the lenses.
Handling Precautions:
• Always wash and rinse hands before handling lenses. Do not get cos-
metics, 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.
• Be sure that before leaving the eye care professional's office, the patient
is able to remove lenses promptly or have someone else available to
remove them.
• Be certain that the fingers or hands are free of foreign materials before
touching lenses, as microscopic scratches of the lenses may occur,
causing distorted vision and/or injury to the eye.
• Always handle lenses carefully and avoid dropping them.
• Do not touch the lens with fingernails.
• Carefully follow the handling, insertion, removal, cleaning disinfecting,
storing and wearing instructions in the Patient Information Booklet for
the PureVision Contact Lenses and those prescribed by the eye care
professional.
• 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.
Solution Precautions:
Do not use the Allergan Ultracare Disinfecting System or any of its compo-
nents (Ultracare Disinfecting Solution, Ultracare Neutralizing Tablets, Lens
Plus Daily Cleaner, and Ultrazyme Enzymatic Cleaner) to clean and disinfect
the PureVision Multi-Focal Contact Lens because the lens dimensions will be
altered.
• Always use fresh unexpired lens care solutions.
• Always follow directions in the package inserts for the use of contact
lens solutions.
• Sterile unpreserved solutions, when used, should be discarded after the
time specified in the labeling directions.
• Always keep the lenses completely immersed in the recommended
storage solution when lenses are not being worn (stored). Prolonged
periods of drying will damage lenses. Follow the lens care directions for
Care for a Dried Out (Dehydrated) Lens in the patient information booklet
if lens surface does become dried out.
• Do not use saliva or anything other than the recommended solution for
lubricating or wetting lenses.
• Tap water, distilled water or homemade saline should not be used as a
substitute for any component in the lens care regimen since they have
been associated with an Acanthamoeba keratitis infection.
• Never use conventional hard contact lens solutions that are not also
recommended for use with prescribed lenses.
• Do not mix or alternate lens care systems or solutions unless indicated in
the lens care system labeling.
• Do not heat the chemical disinfection solution or lenses.
Lens Wearing Precautions:
• Never wear lenses beyond the period recommended by the eye care
professional.
• 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 eye care professional.
• Avoid, if possible, all harmful or irritating vapors and fumes while
wearing lenses.
• If aerosol products are used while wearing lenses, exercise caution and
keep eyes closed until the spray has settled.
Lens Case Precautions:
• Contact lens cases can be a source of bacterial growth. To prevent
contamination and to help avoid serious eye injury, always empty and
rinse the lens case with fresh, sterile rinsing solution and allow to air dry.
• Lens cases should be replaced at regular intervals as recommended by
the lens case manufacturer or eye care professional.
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