BEUDAMED
    FDA Enforcement Class II Terminated

    TECNIS Multifocal Foldable Acrylic Intraocular Lens, Model No. ZMA00 The product is indicated for primary implantation for the visual correction of aphakia in adult patients with and without presbyopia in whom a cataractous lens has been removed by extracapsular cataract extraction and who desire near, intermediate, and distance vision with increased spectacle independence. The lens is intended to be placed in the capsular bag

    Recall: Z-2863-2016 · Reported September 28, 2016

    Enforcement

    Recall Number
    Z-2863-2016
    Event ID
    75051
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Abbott Medical Optics Inc. (AMO)
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 28, 2016
    Initiation Date
    August 26, 2016
    Classification Date
    September 21, 2016
    Termination Date
    December 23, 2016
    Address
    1700 E Saint Andrew Pl, Santa Ana, CA, 92705-4933, United States

    Description

    TECNIS Multifocal Foldable Acrylic Intraocular Lens, Model No. ZMA00 The product is indicated for primary implantation for the visual correction of aphakia in adult patients with and without presbyopia in whom a cataractous lens has been removed by extracapsular cataract extraction and who desire near, intermediate, and distance vision with increased spectacle independence. The lens is intended to be placed in the capsular bag

    Reason

    Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked prior to release and this may result in the release of mislabeled IOLs.

    Code Info

    Serial No. 8213991504 8214001504 8214011504 8214021504 8214031504 8214041504 8214051504 8214061504 8214071504 8214101504 8538801603 8538821603 8538831603 8538841603 8538871603 8538891603 8538901603 8538971603 8538981603 8416821507 8416831507 8416841507 8416851507 8416911507 8416921507 8416951507 8416961507 8416971507 8416991507 8417001507 8417011507 8417021507 8417041507 8417071507 8417081507 8417091507 8417101507 8445191507 8505901605 8505911605 8505961605

    Distribution

    Worldwide Distribution - US nationwide, PR, and Internationally to Canada, Latin America, Europe, Africa, Middle East, and Asia Pacific.

    Quantity

    41 units