BEUDAMED
    FDA Enforcement Class II Terminated

    TEKIA Model 872 Single Piece Hydrophilic Acrylic Intraocular Lenses, Diopter 15.0, Sterile. The firm name on the label is TEKIA, INC., Irvine, CA.

    Recall: Z-0694-2020 · Reported December 25, 2019

    Enforcement

    Recall Number
    Z-0694-2020
    Event ID
    83903
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Tekia, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 25, 2019
    Initiation Date
    November 9, 2018
    Classification Date
    December 17, 2019
    Termination Date
    September 16, 2020
    Address
    17 Hammond Ste 414, Irvine, CA, 92618-1635, United States

    Description

    TEKIA Model 872 Single Piece Hydrophilic Acrylic Intraocular Lenses, Diopter 15.0, Sterile. The firm name on the label is TEKIA, INC., Irvine, CA.

    Reason

    A limited number of lenses may be mislabeled with the incorrect diopter power.

    Code Info

    36 recalled serial numbers from Lot 522-003: U12220229, U12220230, U12220231, U12220232, U12220233, U12220234, U12220235, U12220236, U12220237, V01110221, V01110222, V01110223, V01110224, V02200066, V02200067, V02200068, V02200069, V02200070, V02200071, V03190037, V03190038, V04090143, V04090144, V04090145, V04090146, V04090147, V04090148, V04090149, V04090150, V04090151, V04090152, V01080056, V01080057, V03290055, V03290056, and V05020831. The remaining 45 IOL serial numbers were past expiry and not recalled.

    Distribution

    There was no U.S. distribution. Foreign distribution was made to Iran, Korea, Luxembourg, and Vietnam.

    Quantity

    81 IOLs were distributed but only 36 within expiry were recalled