BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Intraocular Lens

    PMA: P980040 · Supplement: S046 · Decision Apr 28, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59

    Basic Information

    Device Name
    Intraocular Lens
    Trade Name
    TECNIS MULTIFOCAL 1-PIECE INTRAOCULAR LENS WITH TECNIS ITEC PRELOADED DELIVERY SYSTEM
    PMA Number
    P980040
    Supplement Number
    S046
    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
    April 28, 2014
    Date Received
    October 17, 2013
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A CHANGE IN THE PACKAGING/DELIVERY SYSTEM FOR THE TECNIS®MULTIFOCAL 1-PIECE INTRAOCULAR LENS, MODEL ZMB00. THE TECNIS® MULTIFOCAL 1-PIECE INTRAOCULAR LENS IN THE NEW PACKAGING/ DELIVERY SYSTEM IS DESIGNATED THE TECNIS ITEC PRELOADEDDELIVERY SYSTEM, MODEL PMB00, AND IS INDICATED FOR PRIMARY IMPLANTATION FOR THE VISUAL CORRECTION OF APHAKIA IN ADULT PATIENTS WITH AND WITHOUT PRESBYOPIA IN WHOM A CATARACTOUS LENSHAS BEEN REMOVED BY PHACOEMULSIFICATION AND WHO DESIRE NEAR, INTERMEDIATE, AND DISTANCE VISION WITH INCREASED SPECTACLE INDEPENDENCE. THE INTRAOCULAR LENS IS INTENDED TO BE PLACED IN THECAPSULAR 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