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    K Number
    K251683

    Validate with FDA (Live)

    Device Name
    Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Presbyopia (EDOF)
    Manufacturer
    Bruno Vision Care, LLC
    Date Cleared
    2025-12-23

    (207 days)

    Product Code
    LPL
    Regulation Number
    886.5925
    Type
    Traditional
    Panel
    Ophthalmic
    Age Range
    All
    Reference & Predicate Devices
    K240918
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens for Presbyopia with Extended Depth of Focus (EDOF) is indicated for the optical correction of refractive ametropia (myopia and hyperopia) in presbyopic phakic and aphakic persons with non-diseased eyes who exhibit 1.00D or less of astigmatism that does not interfere with visual acuity. The lens mitigates the effects of presbyopia by providing an Extended Depth of Focus (EDOF).

    Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens for Presbyopia with Extended Depth of Focus (EDOF) is to be prescribed for single-use disposable wear and are to be discarded after each removal.

    Device Description

    Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens for Presbyopia with Extended Depth of Focus (EDOF) lens material, vifilcon C is a hydrophilic polymer of 2-hydroxyethyl methacrylate, methacrylic acid and n-vinyl-2-pyrrolidone (NVP) crosslinked with ethylene glycol dimethacrylate (EGDMA) and using azobisisobutyronitrile (AIBN) as the initiator. A UV absorbing monomer, 2-[3-(2H- Benzotriazol-2yl)-4-hydroxyphenyl] ethyl methacrylate, is incorporated into the lens polymer and used to block UV radiation. The lens contains 60% water by weight in a saline solution containing hyaluronic acid and TSP (Tamarind Seed Polysaccharide) polymers. The lens is visibility tinted using Pigment Blue 15 (Copper phthalocyanine) to make the lens more visible for handling.

    The anterior surface of the contact lens is designed with a spherical geometry across the optical zone. The lens includes a centrally located zone with a diameter of 1.0 mm and a dome-shaped profile. This central zone allows the transmission of light but is not intended to focus light to produce distinct retinal images. The curvature of the central zone is steeper than that of the surrounding optical power zone and is designed to provide a power difference relative to the base spherical power of at least +6.00 diopters. The central, functional optically inactive zone is intended to increase the depth of focus for the wearer.

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