BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Lens, Intraocular, Accommodative

    PMA: P030002 · Decision Nov 14, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4

    Basic Information

    Device Name
    Lens, Intraocular, Accommodative
    Trade Name
    CRYSTALENS MODEL AT-45 ACCOMMODATING POSTERIOR CHAMBER INTRAOCULAR LENS (IOL)
    PMA Number
    P030002
    Device Class
    FDA Class 3
    Product Code
    NAA
    Generic Name
    Lens, intraocular, accommodative
    Regulation Number
    886.3600
    Medical Specialty
    Ophthalmic
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    November 14, 2003
    Date Received
    January 24, 2003
    Expedited Review
    Y
    Docket Number
    04M-0012

    Advisory Committee Statement

    APPROVAL FOR THE CRYSTALENS MODEL AT-45 ACCOMMODATING POSTERIOR CHAMBER IOL. THE DEVICE IS INDICATED FOR PRIMARY IMPLANTATION IN THE CAPSULAR BAG OF THE EYE FOR THE VISUAL CORRECTION OF APHAKIA IN ADULT PATIENTS IN WHOM A CATARACTOUS LENS HAS BEEN REMOVED AND IS INTENDED TO PROVIDE NEAR, INTERMEDIATE AND DISTANCE VISION WITHOUT SPECTACLES. THE CRYSTALENS IOL PROVIDES APPROXIMATELY ONE DIOPTER OF MONOCULAR ACCOMMODATION.

    Classifications

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

    Product Code Device Name
    NAA Lens, Intraocular, Accommodative