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

    Intraocular Lens

    PMA: P840060 · Supplement: S048 · Decision Dec 17, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59

    Basic Information

    Device Name
    Intraocular Lens
    Trade Name
    PMMA Single-Piece Posterior Chamber Intraocular Lens
    PMA Number
    P840060
    Supplement Number
    S048
    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
    December 17, 2020
    Date Received
    November 25, 2020
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Introduction of the Turbidimetric Test Method for the Detection of Endotoxin levels for PMMA, AcrySof and AcrySof ReSTOR Intraocular Lenses (IOLs), AcrySert and UltraSert Lens Delivery Systems and Purified Water at Alcon Huntington West Virginia.

    Classifications

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

    Product Code Device Name
    HQL Intraocular Lens