BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Intraocular Lens

    PMA: P930014 · Supplement: S085 · Decision Dec 4, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59

    Basic Information

    Device Name
    Intraocular Lens
    Trade Name
    ACRYSOF TORIC POSTERIOR CHANBER IOL, ACRYSOF TORIC SINGLE-PIECE NATURAL IOL, ACRYSOF IQ TORIC IOL & ACRYSOF TORIC IOL
    PMA Number
    P930014
    Supplement Number
    S085
    Device Class
    FDA Class 3
    Product Code
    HQL
    Generic Name
    intraocular lens
    Regulation Number
    886.3600
    Medical Specialty
    Ophthalmic
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 4, 2015
    Date Received
    September 8, 2015
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE ALCON ONLINE TORIC IOL CALCULATOR WHICH IS A MODIFICATION OF THE TORIC IOL CALCULATORS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ALCON ONLINE TORIC IOL CALCULATOR FOR THE ACRYSOF® TORIC AND IQ TORIC IOLS. THE ACRYSOF® TORIC AND IQ TORIC POSTERIOR CHAMBER INTRAOCULAR LENSES ARE INTENDED FOR PRIMARY IMPLANTATION IN THE CAPSULAR BAG OF THE EYE FOR VISUAL CORRECTION OF APHAKIA AND PRE-EXISTING CORNEAL ASTIGMATISM SECONDARY TO REMOVAL OF A CATARACTOUS LENS IN ADULT PATIENTS WITH OR WITHOUT PRESBYOPIA, WHO DESIRE IMPROVED UNCORRECTED DISTANCE VISION, REDUCTION OF RESIDUAL REFRACTIVE CYLINDER AND INCREASED SPECTACLE INDEPENDENCE FOR DISTANCE VISION.

    Classifications

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

    Product Code Device Name
    HQL Intraocular Lens