BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Intraocular Lens

    PMA: P880081 · Supplement: S042 · Decision Apr 5, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59

    Basic Information

    Device Name
    Intraocular Lens
    Trade Name
    TECNIS CL Foldable Silicone Intraocular Lens
    PMA Number
    P880081
    Supplement Number
    S042
    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
    April 5, 2019
    Date Received
    March 8, 2019
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval to revise the TECNIS® CL, Model Z9002, Directions for Use (DFU) to inform the user of the interaction of silicone material with inherent risk factors (such as asteroid hyalosis) as follows:1) Addition of diabetic retinopathy as an example in Warning #10 to state: The use of silicone lenses in patients with current vitreoretinal disease or those who are at high risk for future vitreoretinal disease (i.e. diabetic retinopathy, etc.) that may require silicone oil as part of therapy should be reconsidered; and2) Addition of the following Warning #11: The use of Silicone intraocular lenses in patients with asteroid hyalosis has been associated with opacification of the implanted 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