BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Lens, Multifocal Intraocular

    PMA: P960028 · Decision Sep 5, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18

    Basic Information

    Device Name
    Lens, Multifocal Intraocular
    Trade Name
    AMO ARRAY MULTIFOCAL UV-ABSORBING SILCONE POSTERIOR CHAMBER INTRAOCULAR LENS
    PMA Number
    P960028
    Device Class
    FDA Class 3
    Product Code
    MFK
    Generic Name
    Lens, multifocal intraocular
    Regulation Number
    886.3600
    Medical Specialty
    Ophthalmic
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    September 5, 1997
    Date Received
    September 3, 1996
    Expedited Review
    N
    Docket Number
    97M-0499

    Advisory Committee Statement

    Approval for the Model SA4ON AMO(R) Array(R) Multifocal Ultraviolet-Absorbing Silicone Posterior Chamber Intraocular Lens (IOL). This device is indicated for the visual correction of aphakia in persons 60 years of age or older in whom a cataractous lens has been removed and who may benefit from useful near vision without reading add and increased spectacle independence across a range of distances where the potential visual effects associated with multifocality are acceptable. The lens is intended to be placed in the capsular bag. The lens is available in powers of +16 to +24 diopters.

    Classifications

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

    Product Code Device Name
    MFK Lens, Multifocal Intraocular