BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Intraocular Lens

    PMA: P930014 · Supplement: S029 · Decision Feb 5, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59

    Basic Information

    Device Name
    Intraocular Lens
    Trade Name
    ACRYSOF IQ TORIC INTRAOCULAR LENS (IOL)
    PMA Number
    P930014
    Supplement Number
    S029
    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
    February 5, 2009
    Date Received
    December 12, 2008
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR IOL MODELS SN6AT3, SN6AT4 AND SN6AT5. THEDEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ACRYSOF IQ TORIC INTRAOCULAR LENSES AND IS INDICATED FOR PRIMARY IMPLANTATION IN THE CAPSULAR BAG OF THE EYE FOR VISUAL CORRECTION OFAPHAKIA 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