BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Lens, Multifocal Intraocular

    PMA: P080010 · Supplement: S031 · Decision Jun 3, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Lens, Multifocal Intraocular
    Trade Name
    TECNIS™ 3-Piece Multifocal, Model ZMA00
    PMA Number
    P080010
    Supplement Number
    S031
    Device Class
    FDA Class 3
    Product Code
    MFK
    Generic Name
    Lens, multifocal intraocular
    Regulation Number
    886.3600
    Medical Specialty
    Ophthalmic
    Advisory Committee
    Ophthalmic
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    June 3, 2026
    Date Received
    May 8, 2026
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    an alternative supplier for the edge blockers for the 3-piece IOLs (AR40e, AR40E, AR40M, AR40MN, ZMA00, and ZA9003)

    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