BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Intraocular Lens

    PMA: P880081 · Supplement: S043 · Decision Jun 27, 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
    S043
    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
    June 27, 2019
    Date Received
    May 28, 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 as follows: Addition of the following to Warning #10: “It has been reported that silicone oil droplets, which remain adherent to the intraocular lens, may reduce the optical quality of the lens and obscure the view of the fundus

    Classifications

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

    Product Code Device Name
    HQL Intraocular Lens