BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Lenses, Soft Contact, Extended Wear

    PMA: P170035 · Decision Apr 30, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56

    Basic Information

    Device Name
    Lenses, Soft Contact, Extended Wear
    Trade Name
    Bausch + Lomb Ultra (samfilcon A) Contact Lenses
    PMA Number
    P170035
    Device Class
    FDA Class 3
    Product Code
    LPM
    Generic Name
    Lenses, soft contact, extended wear
    Regulation Number
    886.5925
    Medical Specialty
    Ophthalmic
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    April 30, 2018
    Date Received
    November 1, 2017
    Expedited Review
    N
    Docket Number
    18M-1791

    Advisory Committee Statement

    Approval for the Bausch + Lomb Ultra (samfilcon A) Contact Lenses. These devices are indicated for:Single Vision Spherical (SVS) Vision CorrectionThe BAUSCH + LOMB ULTRA (samfilcon A) Contact Lens is indicated for extended wear for up to 7 days between removals for cleaning and disinfection or disposal of the lens, as recommended by the eye care practitioner. The lens is indicated for the correction of refractive ametropia (myopia and hyperopia) in aphakic and/or not-aphakic persons with non-diseased eyes, exhibiting astigmatism of 2.00 diopters or less, that does not interfere with visual acuity.Presbyopia Vision CorrectionThe BAUSCH + LOMB ULTRA (samfilcon A) Contact Lens for Presbyopia is indicated for extended wear for up to 7 days between removals for cleaning and disinfection or disposal of the lens, as recommended by the eye care practitioner. The lens is indicated for the correction of refractive ametropia (myopia, hyperopia and astigmatism) and presbyopia in aphakic and/or not-aphakic persons with non-diseased eyes, exhibiting astigmatism of 2.00 diopters or less, that does not interfere with visual acuity. The lens may be prescribed for add powers ranging from +0.75D to +5.00D. Astigmatism Vision CorrectionThe BAUSCH + LOMB ULTRA (samfilcon A) Contact Lens for Astigmatism is indicated for extended wear for up to 7 days between removals for cleaning and disinfection or disposal of the lens, as recommended by the eye care practitioner. The lens is indicated for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and/or not-aphakic persons with non-diseased eyes, exhibiting astigmatism up to 5.00 diopters.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LPM Lenses, Soft Contact, Extended Wear