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BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens are indicated for the correction of visual acuity in aphakic and not-aphakic persons with non-diseased eyes with myopia. The lens may be worn by persons who exhibit refractive astigmatism of 0.50 diopters or less where the astigmatism does not interfere with visual acuity. The lens is available tinted and 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.

BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens is a spherical lens. It is fabricated from polymacon which has been adopted by the United Stated 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 (HEMA) cross-linked with ethylene glycol dimethacrylate (EGDMA), initiated by 2, 2'-azobisisobutyronitrile (AIBN). The lens consists of 62% polymacon and 38% water by weight when immersed in standard saline solution. BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens is available cosmetic tinted to enhance or alter the apparent color of the eye. It is tinted in an annular pattern, providing a clear optic zone, using a combination of one or more of the following 'listed' color additives: Reactive black 5, Iron oxides, Solvent Yellow 18, Titanium dioxide, Carbazole violet, Pigment Blue 36, Phthalocyanine green. The proposed lenses contain only the amount of color additives to accomplish the intended coloring effect. The proposed color lenses are manufactured by sandwiching the pattern layer containing color additives between two layers of lens materials (polymacon). As part of the manufacturing process, the color lenses are thoroughly washed to remove the unbound reactive color additives. Because of the 'sandwich' structure, the color additives will not be removed by lens handling and cleaning/disinfecting procedures. The cosmetic tinting pattern has a minimum clear pupil diameter of 6.0 mm. In the hydrated state, BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus, and it acts as a refracting media to focus light rays on the retina. If the lens dries out, it will become hard and appear somewhat warped; however, it will return to its proper configuration when completely rehydrated in the proper storage solution compatible with the eye. BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens is available in the spherical configuration with the following features and properties: Total diameter: 13.50 mm to 14.50 mm, step:0.10 mm; Base curve: 8.00 mm to 9.00 mm, step: 0.10 mm; Center thickness: 0.050 mm to 0.120 mm; Back vertex power: -10.00D to 0.00D, step: 0.25D. The physical properties of the proposed lens are: Refractive index: 1.435; Light Transmission: ≥95% (at clear region corresponding to pupil, minimum 6.0 mm diameter); Surface character: Hydrophilic; Water content: 38%; Oxygen permeability: 9.01×10-11 (cm²/s) [ml O₂/(ml·mmHg)] at 35°C (revised Fatt method). BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens is supplied sterile in the foil blister pack containing standard saline solution.