BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Intraocular Lens

    PMA: P980040 · Supplement: S144 · Decision Feb 14, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59

    Basic Information

    Device Name
    Intraocular Lens
    Trade Name
    The SENSAR 1-Piece IOL with SmartLOAD Delivery Technology, The TECNIS 1-Piece IOL with SmartLOAD Delivery Technology, Th
    PMA Number
    P980040
    Supplement Number
    S144
    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 14, 2022
    Date Received
    December 20, 2021
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a manufacturing site located at AMO Groningen BV, Groningen, Groningen, 9728, NX, Netherlands as an alternative manufacturing and sterilization facility for the following with SmartLOAD Delivery Technology: SENSAR 1-Piece IOL, TECNIS 1-Piece IOL, TECNIS OptiBlue 1-Piece IOL and TECNIS Eyhance 1-Piece 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