BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Lens, Intraocular, Toric Optics

    PMA: P030002 · Supplement: S035 · Decision Mar 24, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19

    Basic Information

    Device Name
    Lens, Intraocular, Toric Optics
    Trade Name
    CRYSTALENS AND TRULIGN TORIC INTRAOCULAR LENSES (IOLS)
    PMA Number
    P030002
    Supplement Number
    S035
    Device Class
    FDA Class 3
    Product Code
    MJP
    Generic Name
    LENS, INTRAOCULAR, TORIC OPTICS
    Regulation Number
    886.3600
    Medical Specialty
    Ophthalmic
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    March 24, 2016
    Date Received
    July 2, 2015
    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 a manufacturing site located at Bausch & Lomb, Incorporated, 21 Park Place Boulevard North, Clearwater, Florida 33759 as an alternate manufacturing facility for the Crystalens and Trulign IOLs.

    Classifications

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

    Product Code Device Name
    MJP Lens, Intraocular, Toric Optics