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

    Intraocular Lens

    PMA: P980040 · Supplement: S091 · Decision Jun 11, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59

    Basic Information

    Device Name
    Intraocular Lens
    Trade Name
    TECNIS Symfony Toric Extended Range of Vision IOL and TECNIS Toric 1-Piece IOL
    PMA Number
    P980040
    Supplement Number
    S091
    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
    June 11, 2018
    Date Received
    May 15, 2018
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Manufacture the TECNIS® Toric 1-Piece IOL, Models ZCT150, ZCT225, ZCT300, ZCT375, ZCT400, ZCT450, ZCT525 and ZCT600, and the TECNIS® Symfony Toric Extended Range of Vision IOLs, Models ZXT150, ZXT225, ZXT300 and ZXT375, at Johnson & Johnson Surgical Vision, Inc.’s (J&J Vision) AMO Puerto Rico Manufacturing, Inc. facility in Añasco, Puerto Rico.

    Classifications

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

    Product Code Device Name
    HQL Intraocular Lens