BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Intraocular Lens

    PMA: P980040 · Supplement: S131 · Decision Mar 8, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59

    Basic Information

    Device Name
    Intraocular Lens
    Trade Name
    TECNIS Symfony Toric II OptiBlue Extended Range of Vision (ERV) IOLs
    PMA Number
    P980040
    Supplement Number
    S131
    Device Class
    FDA Class 3
    Product Code
    HQL
    Generic Name
    intraocular lens
    Regulation Number
    886.3600
    Medical Specialty
    Ophthalmic
    Advisory Committee
    Ophthalmic
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    March 8, 2021
    Date Received
    February 9, 2021
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Additional image quality manufacturing process step for the TECNIS Symfony Toric II OptiBlue ERV lOLs, Models ZXW50, ZXW225, ZXW300, ZXW375 manufactured at the AMO Groningen B.V. facility.

    Classifications

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

    Product Code Device Name
    HQL Intraocular Lens