BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Intraocular Lens

    PMA: P060022 · Supplement: S020 · Decision Feb 3, 2015
    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
    S020
    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 3, 2015
    Date Received
    December 8, 2014
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO MODIFY THE LABELING TO INCLUDE THE BAUSCH + LOMB IOLINJECTOR (MODEL VIS100) TO THE VALIDATED INSERTERS LIST ON THE LABELING OF THE AKREOS AO60 INTRAOCULAR LENS (IOL).

    Classifications

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

    Product Code Device Name
    HQL Intraocular Lens