BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Intraocular Lens

    PMA: P060022 · Supplement: S002 · Decision Feb 18, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59

    Basic Information

    Device Name
    Intraocular Lens
    Trade Name
    AKREOS POSTERIOR CHAMBER INTRAOCULAR LENS
    PMA Number
    P060022
    Supplement Number
    S002
    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
    February 18, 2009
    Date Received
    October 24, 2008
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR CHANGES TO THE PACKAGING, LABELING AND DESIGN OF THE AKREOS POSTERIOR CHAMBER INTRAOCULAR LENS, MODEL: AKREOS ADVANCED OPTICS ASPHERIC INTRAOCULAR LENS, AO60. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME AKREOS AO MICRO INCISION LENS, MODEL MI60L AND IS INDICATED FOR THE REPLACEMENT OF THE HUMAN CRYSTALLINE LENS IN THE VISUAL CORRECTION OF APHAKIA.

    Classifications

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

    Product Code Device Name
    HQL Intraocular Lens