BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Lens, Intraocular, Toric Optics

    PMA: P980040 · Supplement: S182 · Decision May 19, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

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    Basic Information

    Device Name
    Lens, Intraocular, Toric Optics
    Trade Name
    TECNIS Eyhance™ Toric II IOLs with SmartLOAD™ Delivery Technology (GIU150-600)
    PMA Number
    P980040
    Supplement Number
    S182
    Device Class
    FDA Class 3
    Product Code
    MJP
    Generic Name
    LENS, INTRAOCULAR, TORIC OPTICS
    Regulation Number
    886.3600
    Medical Specialty
    Ophthalmic
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 19, 2026
    Date Received
    February 27, 2026
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    approval for TECNIS Eyhance™ Toric II one-piece IOLs in the SmartLOAD™ Delivery Technology packaging configuration.

    Classifications

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

    Product Code Device Name
    MJP Lens, Intraocular, Toric Optics