BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Intraocular Lens

    PMA: P980040 · Supplement: S117 · Decision Dec 29, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59

    Basic Information

    Device Name
    Intraocular Lens
    Trade Name
    TECNIS Eyhance IOL, TECNIS Eyhance IOL with SmartLOAD Delivery Technology, TECNIS Eyhance IOL with TECNIS Simplicity Del
    PMA Number
    P980040
    Supplement Number
    S117
    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
    December 29, 2020
    Date Received
    June 15, 2020
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    TECNIS EyhanceTM IOL, Model ICB00; TECNIS EyhanceTM IOL with SmartLOADTM Delivery Technology, Model GIB00; TECNIS EyhanceTM IOL with TECNIS SimplicityTM Delivery System, Model DIB00; TECNIS EyhanceTM Toric II IOLs, Models ICU150-600; and TECNIS EyhanceTM Toric II IOLs with TECNIS SimplicityTM Delivery System, Models DIU150-600, which are an extension of the TECNIS family of one-piece IOLs that incorporate an optical modification.

    Classifications

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

    Product Code Device Name
    HQL Intraocular Lens