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

    Intraocular Lens

    PMA: P930014 · Supplement: S115 · Decision Oct 11, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59

    Basic Information

    Device Name
    Intraocular Lens
    Trade Name
    AcrySof Single Piece Intraocular Lenses
    PMA Number
    P930014
    Supplement Number
    S115
    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
    October 11, 2018
    Date Received
    September 12, 2018
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Modifications to the control and monitoring program of the Environmental Controlled Areas for the AcrySof® IQ ReSTOR® Intraocular Lenses (Model Number, SN6AD1) and the AcrySof® Single Piece Intraocular Lenses (Models SN60AT, SA60AT, SN60WF, SA60WF, SN6AT3-T9) at the Alcon Cork, Ireland manufacturing 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