BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P880081 · Supplement: S048 · Decision Sep 27, 2024
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    TECNIS® CL Foldable Silicone IOL
    PMA Number
    P880081
    Supplement Number
    S048
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    September 27, 2024
    Date Received
    June 28, 2023
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    software improvements made to optical metrology system used for 100 percent in-line inspection of TECNIS 3-Piece Acrylic Monofocal, TECNIS 1-Piece with TECNIS® iTec Preloaded Delivery System, SENSAR® 3-Piece Monofocal, TECNIS® CL Foldable Silicone, and 5ODEL SI-11NB UV Absorbing Silicone Posterior intraocular lenses