BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Lens, Intraocular, Phakic

    PMA: P030016 · Supplement: S037 · Decision Jul 19, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5

    Basic Information

    Device Name
    Lens, Intraocular, Phakic
    Trade Name
    Visian ICL Implantable Collamer Lens (ICL)
    PMA Number
    P030016
    Supplement Number
    S037
    Device Class
    FDA Class 3
    Product Code
    MTA
    Generic Name
    Lens, intraocular, phakic
    Medical Specialty
    Unknown
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    July 19, 2019
    Date Received
    April 22, 2019
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval to modify the labeling to include the lioli-24 IOL Delivery System to the current list of recommended delivery systems included in the Directions for Use (DFU) for the NanoFLEX® One-Piece Collamer Intraocular Lens (CIOL), Model CC4204A, and the sphere and toric Visian® ICL Implantable Collamer Lenses (MICL/TMICL).

    Classifications

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

    Product Code Device Name
    MTA Lens, Intraocular, Phakic