BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Intraocular Lens

    PMA: P940007 · Supplement: S005 · Decision Jul 30, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59

    Basic Information

    Device Name
    Intraocular Lens
    Trade Name
    CEEON MODEL 912 FOLDABLE INTRAOCULAR LENS
    PMA Number
    P940007
    Supplement Number
    S005
    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
    July 30, 1999
    Date Received
    July 1, 1999
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for changes to the Warning Section of the lens package insert. Specifically: "When implanting a lens with a smaller optic (less than or equal to 5.5mm), it is recommended that capsulorhexis, with a diameter smaller than the lens optic, be performed. A thorough cortical cleaning before lens insertion is also recommended."

    Classifications

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

    Product Code Device Name
    HQL Intraocular Lens