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

    Intraocular Lens

    PMA: P980040 · Supplement: S146 · Decision Mar 30, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59

    Basic Information

    Device Name
    Intraocular Lens
    Trade Name
    TECNIS IOLs
    PMA Number
    P980040
    Supplement Number
    S146
    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 30, 2022
    Date Received
    March 2, 2022
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Expansion of feed rate, tumbling, high-resolution technology and 100-percent in-line image quality measurement system to 3 existing production lines at AMO Puerto Rico facility for manufacturing TECNIS Symfony and TECNIS Symfony Toric II Optiblue Extended Range of Vision Intraocular Lenses (IOL) as well as TECNIS Synergy and TECNIS Synergy Toric II lOLs with TECNIS Simplicity Delivery System.

    Classifications

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

    Product Code Device Name
    HQL Intraocular Lens