BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P980040 · Supplement: S174 · Decision Sep 11, 2025
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    FEI Numbers
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    Basic Information

    Trade Name
    TECNIS Odyssey IOL with TECNIS SIMPLICITY Delivery System (DRN00V); TECNIS Odyssey Toric II IOLs with TECNIS SIMPLICITY
    PMA Number
    P980040
    Supplement Number
    S174
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    September 11, 2025
    Date Received
    June 13, 2025
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    approval for a change in the endotoxin specification limit for preloaded intraocular lens storage/delivery systems to harmonize this limit with the relevant intraocular device ISO Standard and FDA Guidance.