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The Chic View (polymacon) Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of 0.75 diopters or less where the astigmatism does not interfere with visual acuity. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye. Daily wear replacement schedules may vary from patient and should be decided by eyecare practitioners in consultation with their patients. Frequent/Planned Replacement Wear: Eyecare practitioners may prescribe any of the above lenses for frequent/planned replacement wear, with cleaning disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfecting system. Disposable Wear: Eyecare practitioners may prescribe any of the above lenses for Daily Disposable Wear. When Prescribed for Daily Disposable Wear the lenses are not to be used with disinfecting systems as they are to be discarded after a single use.

The ChicView soft contact lenses are hemispherical shells with molded spherical base curves and molded front surfaces. The ChicView soft contact lenses are fabricated from polymacon, which has been adopted by the United States Adopted Names Council (USAN). The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution. The nonionic lens material. (polymacon) is a hydrophilic polymer of 2-Hydroxyethyl methacrylate (2-HEMA) and cross-linked with ethylene glycol dimethacrylate (EGDMA), plus an initiator. The co-polymer consists of 62% polymacon and 38% water by weight when immersed in saline solution. ChicView lenses are available clear, tinted for visibility/handling, and tinted to enhance or alter the apparent color of the eye. Tinted or color lens designs may be distributed under unique or "private label" trade names. ChicView lenses are available in gray, green, violet, brown, blue or blackwhich are tinted with one or a combination of one or more of the following "listed" color additives: | Name of Colorant | Listing | |-----------------------|------------------| | D&C Yellow 10 | 21 CFR § 74.3710 | | Titanium Dioxide | 21 CFR § 73.3126 | | Iron Oxide (Red) | 21 CFR § 73.3125 | | D&C Green No. 6 | 21 CFR § 74.3206 | | Reactive Blue 19 | 21 CFR § 73.3127 | | C.I. Reactive black 5 | 21 CFR § 73.3127 | Lenses that contain a unique tinting pattern are subsequently processed to incorporate the 'listed' color additives, and contain only the amount of color additive needed to accomplish the intended coloring effect. When producing the tinted or color lenses, the manufacturing process alters and/or changes the specifications to the clear version of a contact lens by entrapment of the listed color additives in the center of the contact lens (surrounded by layers of contact lens material) in a location that corresponds to the iris. The color additives used are not removed by lens handling and cleaning/disinfecting procedures. Except for affecting the amount of light transmittance through the lens, the coloring process does not alter the original characteristics of the pre-tinted lens. The color lens tinting pattern has a minimum Clear Pupil diameter of 6.0 mm. In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a transparent or colored optical surface. The (polymacon) soft hydrophilic contact lens has a spherical back surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard and appear somewhat warped; it will return to its proper configuration when completely rehydrated in the proper storage solution. The physical properties of the lens are: | Refractive Index | 1.435 | |-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------| | Light Transmission (clear) | greater than 98% | | Light Transmission (tinted/color) | greater than 98% (at clear region corresponding to pupil, minimum 6.0 mm diameter);<br>Opaque or 0-10% (at tinted region corresponding to iris) | | Surface Character | hydrophilic | | Water Content | 38±2% | | Specific Gravity | 1.17 (hydrated) | | Oxygen Permeability | 11.15 x 10-11 (cm²/sec)(mlO₂)/(ml x mmHg @ 35°C)) (revised Fatt method) | The hydrophilic characteristics allow aqueous solution to enter the lens, and in its fully hydrated state the lens is approximately 38% water by weight. The lenses will be manufactured in the spherical configuration with the following features and properties: | Chord Diameter: | 12.00 mm to 15.50 mm | |-------------------|-----------------------------------| | Center Thickness: | 0.07 mm to 0.13 mm | | Base Curve: | 7.0 mm to 9.0 mm | | Power Range | -20.00D to +20.00D in 0.25D steps | ChicView lenses are supplied sterile in saline solution containing blister packages with a base made from polypropylene and a laminated foil seal on top. Blister package labeling is printed with the appropriate lot numbering, expiration dating, and lens parameter identification. Expiration dating has been established based on studies of product stability, package integrity, and validation of the sterilization process.