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510(k) Data Aggregation

    K Number
    K153305
    Device Name
    EyeYon (hioxirilcon D) Soft (hydrophillc) ContactLensesfor Daily Wear, Hyper-CL (hioxirilcon D)TherapeuticSoft (hydrophillc) Contact Lensesfor Daily Wear
    Manufacturer
    Date Cleared
    2016-04-08

    (144 days)

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

    EYEYON MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The EyeYon (hioxifilcon D) Spherical 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 EyeYon (hioxifilcon D) Toric soft contact lenses for daily wear are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eyes with 4.00 diopters (D) or less of astigmatism. The EyeYon (hioxifilcon D) Multifocal soft contact lenses for daily wear are indicated for the optical correction of refractive ametropia (myopia, and/or presbyopia) in phakic or aphakic persons with non-diseased eyes who may require a reading addition of +3.00 diopters (D) or less and who may have up to approximately 0.75 diopters of astigmatism. The EyeYon (hioxifilcon D) Multifocal Toric soft contact lenses for daily wear are indicated for the optical correction of refractive ametropia (myopia, astigmatism and presbyopia) in phakic or aphakic persons with non-diseased eyes. The lenses may be worn by persons who have 4.00 diopters (D) or less of refractive and/or corneal astigmatism. The Hyper-CL™ (hioxifilcon D) Therapeutic soft contact lenses for daily wear are indicated for the optical correction of refractive ametropia in phakic persons with non-diseased eyes. The lenses may be prescribed for therapeutic use to promote corneal healing and relieve corneal pain by protecting the treatment of acute or chronic pathologies, such as corneal edema, corneal erosions, entropion, bullous keratopathy, and corneal dystrophies as well as post-surgical conditions resulting from cataract extraction and corneal surgery. Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.
    Device Description
    The EveYon (hioxifilcon D) Soft (hydrophilic) Contact Lenses & Hyper-CL™ (hioxifilcon D) Therapeutic Soft (hydrophilic) Contact Lenses for Daily Wear are fabricated from hioxifilcon D, which in the dry (unhydrated) state may be machined and polished. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution. The EveYon (hioxifilcon D) Soft (hydrophilic) Contact Lenses & Hyper-CL™ (hioxifilcon D) Therapeutic Soft (hydrophilic) Contact Lenses are manufactured from CONTAFLEX 54 optical blanks, supplied by Contamac Ltd (cleared under K150590). The non-ionic lens material, (hioxifilcon D) is a co-polymer of 2-Hydroxyethylmethacrylate (2-HEMA) and 2,3- Dihydroxypropyl Methacrylate (Glycerol Methacrylate), cross-linked with ethylene glycol dimethacrylate (EGDMA), plus an initiator. The co-polymer consists of 46% hioxifilcon D and 54% water by weight when immersed in normal buffered saline solution. The hioxifilcon D name has been adopted by the United States Adopted Names Council (USAN). In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The (hioxifilcon D) 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 however, it will return to its proper configuration when completely rehydrated in the proper storage solution. The Hyper-CL™ (hioxifilcon D) Therapeutic Soft (hydrophilic) Contact Lens design includes two (2) different base curves, and a peripheral groove including 4-16 fenestrations. When worn on the eve the Hyper-CL™ lens design creates a tear film reservoir between the corneal surface and the back surface of the contact lens. The fenestrations improve tear mixing efficiency.
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