1 Oxygen Permeability (Dk):* UNITS. SOFLENS Contact Lens (clear).. SOFLENS Visibility Tinted Contact Lens NaturalTint Contact Lens Average Light Transmittance: ** Y Value SOFLENS Contact Lens (Clear) - approximately 98%. SOFLENS SOFLENS Visibility Tinted Contact Lens - approximately 86%. (polymacon). to 98%. Contact Lenses NaturalTint Contact Lenses Blue - approximately 82%. IMPORTANT: Aqua - approximately 84%. This package insert is effective as of March 1997 and Green - approximately 76%. supersedes all prior inserts for the products described Brown - approximately 62%. below. Please read carefully and keep this information for future use. This package insert is intended for the eye *Dk = units x 10 -11[cm3O2(STP) x cm]/(sec x cm2 x care practitioner, but should be made available to patients mm Hg) at 34 C (Polarographic Method).
2 Upon request. The eye care practitioner should provide the **CIE light transmittance will differ by average thickness patient with the patient instructions that across the optical zone for lenses tinted with Reactive pertain to the patient's prescribed lens. Blue 246. SOFLENS (polymacon) Visibility Tinted Contact Lenses CAUTION: (including Occasions Multifocal, , Sofspin, O3, Federal ( ) Law Prohibits Dispensing Without O4, Optima 38 and Optima 38/SP) are tinted blue Prescription. using Reactive Blue 246 or 1,4-bis[4-(2-methacry- loxyethyl)phenylamino]anthraquinone to make the lens VISION CORRECTION USE more visible for handling purposes. The apparent color of For all Bausch & LOMB SOFLENS (polymacon) the SOFLENS (polymacon) Visibility Tinted Contact Contact Lenses (including clear, visibility tinted, Lenses may decrease slightly following repeated cosmetically tinted, daily wear or extended wear polymacon disinfection.)
3 This will not affect the safety or performance hydrophilic contact lenses) of the lens. SOFLENS includes the following types: NaturalTint Contact Lenses are tinted with any of, or with O3, O4, Occasions Multifocal, Optima 38, Optima combinations of, the following lens colors: blue, green, 38/SP, U3, U4, Sofspin , HO3, HO4, B3, B4, , F3, aqua, brown and yellow. These lenses are tinted with H3, H4, N and NaturalTint Contact Lenses synthetic dyes Spherical Lenses for: Nearsightedness (Myopia), (Blue) 7,16-Dichloro-6,15-dihydro-5,9,14,18- Farsightedness (Hyperopia), Presbyopia, Not-aphakic anthrazinetetrone, and/or after Cataract Surgery (Aphakia). (Green) 16,17-Dimethoxydinaphtho[1,2,3-cd:3',2', 1'- DESCRIPTION lm]perylene-5,10-dione, All Bausch & Lomb SOFLENS (Clear and Visibility Tinted) (Brown) 16,23-Dihydrodinaphtho[2,3-a:2',3'-i], Contact Lenses are available as Spherical lenses.
4 The lens naphtho[2',3':6,7] indolo[2,3-c]carbazole- material (polymacon), is a hydrophilic polymer of 5,10,15,17,22,24-hexone or 2-hydroxyethyl methacrylate, and is water by weight when immersed in saline solution. These lenses (Yellow) N,N'-(9,10-Dihydro-9,10-dioxo-1,5- are hemispherical flexible shells of the following anthracenediyl)bisbenzamide) that impart colors to the dimensions: lens which combine with eye color to produce a natural Chord Diameter: to appearance. Center Thickness: to ACTIONS. Posterior Apical Radius: to In its hydrated state, the Bausch & LOMB SOFLENS . (polymacon) Contact Lens when placed on the cornea Powers (Spherical): See Indications . acts as a refracting medium to focus light rays on the retina. The physical/optical properties of the lens are: INDICATIONS (USES). Specific Gravity: Daily Wear Refractive Index: The Bausch & LOMB SOFLENS (polymacon) Contact Surface Character: Hydrophilic Lenses are indicated for daily wear for the correction of Water Content: refractive ametropia (myopia and hyperopia) in aphakic and/or non-aphakic persons with non-diseased eyes, that Allergic reactions of ocular surfaces or adnexa exhibit astigmatism of diopters or less and can (surrounding tissue) that may be induced or exaggerated obtain satisfactory visual acuity, in a power range of by wearing contact lenses or use of contact lens to + diopters.
5 Solutions Occasions Multifocal and are indicated for daily Allergy to any ingredient, such as mercury or wear for the correction of refractive ametropia (myopia Thimerosal, in a solution which is to be used to care for and hyperopia) in phakic, presbyopic persons with non- the Bausch & LOMB SOFLENS (polymacon) Contact diseased eyes, that exhibit astigmatism of diopters Lens or less. The bifocal lens is indicated for patients requiring Any active corneal infection (bacterial, fungal, or viral). up to diopters of refractive add. The lens provides a If eyes become red or irritated nominal functional add of diopters in a power range WARNINGS. of to + for Occasions Multifocal, and to Patients should be advised of the following warnings + diopters for pertaining to contact lens wear: NaturalTint Contact Lenses are indicated for daily wear Problems with contact lenses and lens care products for the correction of refractive ametropia (myopia and could result in serious injury to the eye.)
6 It is essential hyperopia) in aphakic and/or non-aphakic persons with that patients follow their eye care practitioner's direction non-diseased eyes, that exhibit astigmatism of and all labeling instructions for proper use of lenses and diopters or less and can obtain satisfactory visual acuity, lens care products, including the lens case. Eye in a power range of to + diopters. These may problems, including corneal ulcers, can develop rapidly also be used for color enhancement of the eye and for and lead to loss of vision. ocular masking. Daily wear lenses are not indicated for overnight wear, Eye care practitioners may prescribe the lenses for and patients should be instructed not to wear these traditional or frequent/planned replacement wear, with lenses while sleeping. Clinical studies have shown that cleaning disinfection and scheduled replacement (see the risk of serious adverse reactions is increased when WEARING SCHEDULE).
7 The lenses may be disinfected contact lenses are worn overnight. using either a heat or chemical disinfection system. Studies have shown that contact lens wearers who are Extended Wear smokers have a higher incidence of adverse reactions The Bausch & Lomb SOFLENS (polymacon) O3 and O4 than nonsmokers. Contact Lenses are indicated for extended wear from 1 to NaturalTint Contact Lenses reduce the amount of light 7 days between removals for cleaning and disinfection or entering the eye and should not be used under reduced replacement as recommended by the eye care practitioner. illumination conditions such as night driving. The lenses are indicated for the correction of visual acuity As with all soft bifocal lenses, Occasions Multifocal of myopic and hyperopic, phakic patients with non- and Bifocal contact lenses may require a number diseased eyes, that exhibit astigmatism of diopters of fitting procedures before a final lens selection is or less and can obtain satisfactory visual acuity in a made.
8 As a patient's add requirement increases, the power range of to + diopters. probability of the patient achieving good visual acuity Eye care practitioners may prescribe the lens for traditional decreases. A realistic visual expectation for the average or frequent/planned replacement wear, with cleaning patient is that distance VA will be comparable to disinfection and scheduled replacement (see WEARING spectacles; near VA probably slightly less. SCHEDULE). The lenses may be disinfected using either a EXTENDED WEAR. heat or chemical disinfection system. The risk of ulcerative keratitis has been shown to be CONTRAINDICATIONS (REASONS NOT TO USE): greater among users of extended wear contact lenses DO NOT USE the Bausch & LOMB SOFLENS than among users of daily wear contact lenses. The risk among extended wear lens users increases with the (polymacon) Contact Lens when any of the following number of consecutive days that the lenses are worn conditions exist: between removals, beginning with the first overnight Acute and subacute inflammation or infection of the use.
9 Some researchers believe that these complications anterior chamber of the eye are caused by one or more of the following: a weakening Any eye disease, injury, or abnormality that affects the of the cornea's resistance to infections, particularly cornea, conjunctiva, or eyelids during a closed-eye condition, as a result of hypoxia; an Severe insufficiency of lacrimal secretion (dry eyes). eye environment which is somewhat more conducive to Corneal hypoesthesia (reduced corneal sensitivity), if the growth of bacteria and other microorganisms, non-aphakic particularly when a regular periodic lens removal and Any systemic disease that may affect the eye or be disinfecting or disposal schedule has not been adhered exaggerated by wearing contact lenses 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 before reinserting the lenses.
10 If it is not possible to flush lens deposits; damage to the lens; improper fitting; the eyes, wait a minimum of 1 hour before reinserting length of wearing time; and the presence of ocular the lenses. If replaced too soon, the lenses may absorb debris or environmental contaminants. While the great residual fluorescein. majority of patients successfully wear contact lenses, Before leaving the eye care practitioner's office, the extended wear of lenses also is reported to be associated patient should be able to promptly remove lenses or with a higher incidence and degree of epithelial should have someone else available who can remove the microcysts and infiltrates, and epithelial polymegathism, lenses for him or her. which require consideration of discontinuation or Eye care practitioners should instruct the patient to restriction of extended wear.