BEUDAMED
    FDA Recall Terminated

    TEKLENS II (TEKIA label) and Polylens A60 (Polytech label) Model 614, intraocular lens (IOL)

    Recall: Z-1311-06 · Initiated July 2, 2004

    Recall

    Recall Number
    Z-1311-06
    Event Number
    35817
    Firm
    Tekia Inc
    FEI Number
    3002023310
    Product Code
    HQL
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 2, 2004
    Posted
    August 2, 2006
    Terminated
    February 10, 2012
    Address
    17 Hammond, Suite 414, Irvine, CA, 92618

    Description

    TEKLENS II (TEKIA label) and Polylens A60 (Polytech label) Model 614, intraocular lens (IOL)

    Reason

    Intraocular lenses (IOLs) with power of 17.0 D and 22.5 D are mislabeled with each other's labels.

    Action

    On 7/2/04, TEKIA informs first customer to stop shipment of 22.5 D IOLs from batch E0310 due to suspicion of mislabeling. On 7/8/2004 TEKIA informs first customer to stop shipping IOLs belonging to two shop orders (22.5 D E03100099-120- twenty-two (22) units, 17.0 D E100064-89- twenty-six (26) units), and requests them to retrieve products with those serial numbers from their customers. TEKIA informs second customer of suspicion of mislabeling, requests stop shipment and retrieval from their customers of the IOLs belonging to two shop orders: twelve (12) IOLs 22.5 D E03100146-153 -- eight (8) units, 22.5 D E03100218-221 --four (4) units. Return Goods Authorizations are issued.

    Distribution

    Germany.

    Quantity

    60 units/IOLs total