Multi-Focal
Visibility Tinted
Contact Lenses
PACKAGE INSERT/
FITTING GUIDE
CAUTION: Federal (U.S.A.) law restricts this device to sale by or on the order of a licensed practitioner.
IMPORTANT:
This package insert and fitting guide has been developed to provide practitioners with information covering characteristics of the BAUSCH & LOMB® PureVision® Multi-Focal (balafilcon A) Visibility Tinted Contact Lens and to illustrate fitting procedures. It is effective as of October 2005 and supersedes all prior fitting guides for the product described. Please read carefully and keep this information for future use.
This package insert and fitting guide is intended for the eye care professional, but should be made available to patients upon request. The eye care professional should provide the patient with the patient instructions that pertain to the patient's prescribed lens and the recommended wearing schedule.
DESCRIPTION:
The BAUSCH & LOMB® PureVision® Multi-Focal (balafilcon A) Visibility Tinted Contact Lens is a soft hydrophilic contact lensthat is a front surface asphere consisting of multiple aspheric zones with a spherical base curve. The most plus power is in the center of the lens, progressing to more minus in the periphery. The lens material, balafilcon A, is a copolymer of a silicone vinyl carbamate, N-vinyl-pyrrolidone, a siloxane crosslinker and a vinyl alanine wetting monomer, and is 36% water by weight when immersed in a sterile borate buffered saline solution. This lens is tinted blue with up to 300 ppm of Reactive Blue Dye 246.
The physical / optical properties of the lens are:
Specific Gravity: |
1.064 |
Refractive Index: |
1.426 |
Light Transmittance: |
C.I.E. value - at least 95% |
Water Content: |
36% |
Oxygen Permeability: |
91 x 10-11[cm3O2(STP) x cm]/(sec x cm2 x |
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mmHg) @ 35° C Polarographic Method |
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(Boundary and Edge Corrected) |
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101 x 10-11[cm3O2(STP) x cm]/(sec x cm2 x |
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mmHg) @ 35°C Polarographic Method |
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(Boundary Corrected, Non-Edge Corrected) |
The PureVision Multi-Focal Contact Lenses, with the AerGel™ lens material, are manufactured by a cast molding process and are surface treated by the Performa™ surface treatment process which transforms hydrophobic silicone to hydrophilic silicate.
LENS PARAMETERS AVAILABLE:
The BAUSCH & LOMB PureVision® Multi-Focal (balafilcon A) Visibility Tinted Contact Lens is a hemispherical shell of the following dimensions:
Diameter: |
14.0mm |
Center Thickness: 0.05mm to 0.50mm |
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Base Curve: |
8.6mm |
Sphere Powers: |
+6.00D to -10.00D (0.25D increments) |
ADD Powers: |
Low (+0.75D to +1.50D) and High (+1.75D to +2.50D) |
HOW THE LENS WORKS (ACTIONS):
In its hydrated state, the BAUSCH & LOMB® PureVision® Multi-Focal (balafilcon A) Visibility Tinted Contact Lens when placed on the cornea, acts as a refracting medium to focus light rays on the retina.
INDICATIONS:
The BAUSCH & LOMB® PureVision® Multi-Focal (balafilcon A) Visibility Tinted Contact Lens is indicated for daily wear or extended wear from 1 to 30 days between removals, for cleaning and disinfection or disposal of the lens, as recommended by the eye care professional. The lens is indicated for the correction of refractive ametropia (myopia, hyperopia and astigmatism) and presbyopia in aphakic and/or not-aphakic persons with non-diseased eyes, exhibiting astigmatism of up to 2.00 diopters or less, that does not interfere with visual acuity. The lens may be prescribed for Frequent/Planned Replacement Wear or Disposable Wear in spherical powers ranging from +6.00D to -18.00D when prescribed for up to 30 days of extended wear and from +20.00D to –20.00D for daily wear or extended wear up to 7 days with add powers ranging from +0.75D to +5.00D.
Note: See the WARNINGS reference to the relationship between lens wearing schedule and corneal complications.
FREQUENT/PLANNED REPLACEMENT WEAR
When prescribed for Frequent/Planned Replacement Wear, the PureVision Multi-Focal Contact Lens is to be cleaned, rinsed and disinfected each time it is removed from the patient’s eye and discarded after the recommended wearing period prescribed by the eye care professional. The lens may be disinfected using a chemical disinfection system.
DISPOSABLE WEAR
When prescribed for Disposable Wear, the PureVision Multi-Focal Contact Lens is to be discarded after each removal.
CONTRAINDICATIONS (REASONS NOT TO USE):
DO NOT USE the BAUSCH & LOMB® PureVision® Multi-Focal (balafilcon A) Visibility Tinted Contact Lens when any of the following conditions exist:
•Acute and subacute inflammation or infection of the anterior chamber of the eye
•Any eye disease, injury, or abnormality that affects the cornea, conjunctiva, or eyelids
•Severe insufficiency of lacrimal secretion (dry eyes)
•Corneal hypoesthesia (reduced corneal sensitivity)
•Any systemic disease that may affect the eye or be exaggerated by wearing contact lenses
•Allergic reactions of ocular surfaces or adnexa (surrounding tissue) that may be induced or exaggerated by wearing contact lenses or use of contact lens solutions
•Allergy to any ingredient, such as mercury or Thimerosal, in a solution which is to be used to care for the PureVision Mulit-Focal Contact Lens
•Any active corneal infection (bacterial, fungal, or viral)
•If eyes become red or irritated
WARNINGS:
After a thorough eye examination, including appropriate medical background, patients should be fully apprised by the prescribing eye care professional of all the risks with contact lens wear. Patients should be advised of the following warnings pertaining to contact lens wear:
•Problems with contact lenses and lens care products could result in serious injury to the eye. It is essential that patients follow their eye care professional's direction and all labeling instructions for proper use of lenses and lens care products, including the lens case. Eye problems, including corneal ulcers, can develop rapidly and lead to loss of vision.
•When prescribed for Frequent/Planned Replacement Wear, the need for strict compliance with the care regimen including cleaning of the lens case, wearing restrictions, wearing schedule, and follow-up visit schedule should be emphasized to the patient.
•Studies have shown that contact lens wearers who are smokers have a higher incidence of adverse reactions than nonsmokers.
EXTENDED WEAR
•The risk of microbial keratitis has been shown to be greater among users of extended wear contact lenses than among users of daily wear contact 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.
Some researchers believe that these complications are caused by one or more of the following: a weakening of the cornea's resistance to infections, particularly during a closed-eye condition, as a result of hypoxia; an eye environment which is somewhat more conducive to the growth of bacteria and other microorganisms, particularly when a regular periodic lens removal and disinfecting or disposal schedule has not been adhered to by the patient; improper lens disinfection or cleaning by the patient; contamination of lens care products; poor personal hygiene by the patient; patient unsuitability to the particular lens or wearing schedule; accumulation of lens deposits; damage to the lens; improper fitting; length of wearing time; and the presence of ocular debris or environmental contaminants.
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•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 endothelial polymegathism, which require consideration of discontinuation or restriction 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 wearing times vary from not prescribing extended wear at all to prescribing flexible wearing times from occasional overnight wear to prescribing extended 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 available 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 permeability, 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 professional.
•Patients who wear aspheric contact lenses, such as the Bausch & Lomb PureVision Multi-Focal, to correct presbyopia may not achieve the best corrected 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 fluorescein 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 recommended 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 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. Waterbase 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 components (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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