BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Intraocular Lens

    PMA: P980040 · Supplement: S160 · Decision Sep 27, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59

    Basic Information

    Device Name
    Intraocular Lens
    Trade Name
    TECNIS 1-Piece IOL with TECNIS® iTec Preloaded Delivery System, SENSAR® 3-Piece Monofocal IOL
    PMA Number
    P980040
    Supplement Number
    S160
    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
    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

    Classifications

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

    Product Code Device Name
    HQL Intraocular Lens