BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Lens, Multifocal Intraocular

    PMA: P980040 · Supplement: S156 · Decision May 23, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18

    Basic Information

    Device Name
    Lens, Multifocal Intraocular
    Trade Name
    TECNIS Next-Generation Presbyopia-Correcting IOL
    PMA Number
    P980040
    Supplement Number
    S156
    Device Class
    FDA Class 3
    Product Code
    MFK
    Generic Name
    Lens, multifocal intraocular
    Regulation Number
    886.3600
    Medical Specialty
    Ophthalmic
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 23, 2023
    Date Received
    December 2, 2022
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for TECNIS Next-Generation Presbyopia-Correcting (PC) Intraocular lens (IOL) with TECNIS SimplicityTM Delivery System, Model DRN00V which is a design modification of TECNIS Synergy IOL, Model DFR00V.

    Classifications

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

    Product Code Device Name
    MFK Lens, Multifocal Intraocular