BEUDAMED
    FDA Enforcement Class II Terminated

    TEKIA Single Piece Hydrophilic Acrylic Intraocular Lenses, Model 811

    Recall: Z-0237-2016 · Reported November 18, 2015

    Enforcement

    Recall Number
    Z-0237-2016
    Event ID
    72434
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Tekia, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 18, 2015
    Initiation Date
    September 29, 2015
    Classification Date
    November 6, 2015
    Termination Date
    December 3, 2015
    Address
    17 Hammond Ste 414, N/A, Irvine, CA, 92618-1635, United States

    Description

    TEKIA Single Piece Hydrophilic Acrylic Intraocular Lenses, Model 811

    Reason

    Tekia is recalling the Single Piece Hydrophillic Acrylic Intraocular Lenses (IOLs) because they may be labeled with the incorrect diopter power.

    Code Info

    SN: U07310001 thru U07310040 , 07310050 thru U07310059

    Distribution

    Internationally to Vietnam.

    Quantity

    50 units