BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Intraocular Lens

    PMA: P910061 · Supplement: S013 · Decision Jul 20, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59

    Basic Information

    Device Name
    Intraocular Lens
    Trade Name
    LI61AOV (ADVANCED OPTICS VIOLET-SHIELD) LENS
    PMA Number
    P910061
    Supplement Number
    S013
    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
    July 20, 2006
    Date Received
    March 30, 2006
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR LABELING CHANGES FOR THE ADVANCED OPTICS VIOLET-SHIELD MODEL LI61AOV INTRAOCULAR LENS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ADVANCED OPTICS VIOLET-SHIELD MODEL LI61AOV INTRAOCULAR LENS AND IS INDICATED TO BE USED FOR PRIMARY IMPLANTATION FOR THE CORRECTION OF APHAKIA IN ADULT PATIENTS WHERE A CATARACTOUS LENS HAS BEEN REMOVED BY EXTRACAPSULAR CATARACT EXTRACTION METHODS. THE LENS IS INTENDED FOR PLACEMENT IN THE CILIARY SULCUS OR CAPSULAR BAG.

    Classifications

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

    Product Code Device Name
    HQL Intraocular Lens