BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Intraocular Lens

    PMA: P990080 · Supplement: S004 · Decision Mar 1, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59

    Basic Information

    Device Name
    Intraocular Lens
    Trade Name
    FOLDABLE ULTRAVIOLET LIGHT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS TECNIS, WITH Z-SHARP OPTIC TECHNOLOGY
    PMA Number
    P990080
    Supplement Number
    S004
    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
    March 1, 2004
    Date Received
    April 15, 2003
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO REVISE THE PACKAGE INSERT WITH CLAIMS REGARDING REDUCTION IN POSTOPERATIVE SPHERICAL ABERRATIONS COMPARED TO LENSES WITH SPHERICAL OPTICS AND IMPROVED NIGHT DRIVING SIMULATOR PERFORMANCE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME TECNIS AND IS INDICATED FOR PRIMARY IMPLANTATION FOR THE VISUAL CORRECTION OF APHAKIA IN ADULTS IN WHOM A CATARACTOUS LENS HAS BEEN REMOVED BY PHACOEMULSIFI-CATION. THE LENSES ARE INTENDED TO BE PLACED IN THE 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