BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Intraocular Lens

    PMA: P190018 · Supplement: S012 · Decision Feb 14, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59

    Basic Information

    Device Name
    Intraocular Lens
    Trade Name
    Clareon PanOptix Trifocal UV Absorbing Hydrophobic Intraocular Lens (IOL), Clareon PanOptix Toric Trifocal Hydrophobic I
    PMA Number
    P190018
    Supplement Number
    S012
    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
    February 14, 2022
    Date Received
    August 26, 2021
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for additional manufacturing sites at Alcon Research, LLC (AODC-South) located at 6065 Kyle Lane Huntington, West Virginia and Alcon Research, LLC (AODC-North) located at 2 Vision Lane Lesage, West Virginia. The AODC-South facility performs the Injection Moulding through the Cosmetic Inspection manufacturing steps and the AODC-North facility performs the Pouching & Barseal through the Overwrap steps of the manufacturing process, as well as sterilization and distribution.

    Classifications

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

    Product Code Device Name
    HQL Intraocular Lens