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510(k) Data Aggregation

    K Number
    K111345
    Device Name
    SEE CLEAR SOFT CONTACT LENS, SEE CLEAR COLOR SOFT CONTACT LENS, FIERCE SOFT CONTACT LENS
    Date Cleared
    2011-11-02

    (173 days)

    Product Code
    Regulation Number
    886.5925
    Why did this record match?
    Applicant Name (Manufacturer) :

    THE SEE CLEAR COMPANY, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The See Clear Spherical Soft Contact Lenses (polymacon) for Daily Wear are indicated for the correction of visual acuity in aphakic and not aphakic person with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of .50 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. Eye care practitioners may prescribe 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.
    Device Description
    The See Clear Spherical Soft Contact Lens (polymacon) for Daily Wear (clear. visibility-tinted, and decorative) are hemispherical shells with molded spherical base curves and lathe-cut front surfaces and are designed to fit over the corneal surface of the eye. These lenses are designed with varying base curves that conform to the shape of the radius of the cornea and center over the apex of the cornea to provide correction of refractive ametropia (myopia, hyperopia, and astigmatism) in aphakic and not-aphakic persons with non-diseased eves. The non-ionic lens material, polymacon, is a hydrophilic copolymer of 2hydroxyethyl methacrylate (2-HEMA) cross-linked with ethylene glycol dimethacrylate (EGDMA), plus an initiator. It consists of consists of 62% polymacon and 38% water by weight when immersed in normal buffered saline solution. The lenses are available clear, or with a visibility-handling tint, or with a decorative tint intended to enhance or alter the apparent color of the eye for dayto-day cosmetic or occasional theatrical purposes. These decorative designs may be distributed under a unique or "private label" trade name such as See Clear, See Clear Color, and Fierce Contact Lenses. Lenses are tinted only with FDAapproved ("listed") listed color additives for which FDA has previously reviewed the toxicology / biocompatibility profiles. Tinted lenses contain only the amount of color additive needed to accomplish the intended decorative effect. In the dry (unhydrated) state the lens is machined and polished. 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. When placed on the cornea, the See Clear Spherical Soft Contact Lens (polymacon) for Daily Wear acts as a refracting medium to focus light rays on the retina. 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, however it will return to its proper configuration when completely rehydrated in the proper storage solution. The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 38% water by weight.
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