BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TYPE 7B

    MDR report key: 1911000 · Received November 24, 2010

    Report

    Report Number
    1119421-2010-01327
    Event Type
    Injury
    Date Received
    November 24, 2010
    Date of Event
    October 13, 2010
    Report Date
    October 15, 2010
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P840060
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR ANALYSIS AND WAS VERIFIED TO HAVE SIGNS OF HANDLING. BOTH HAPTICS WERE BROKEN-GUSSET AREA WITH PORTIONS REMAINING IN THE HAPTIC INSERTION AREA (NOT RETURNED). THE OPTIC WAS SPLIT IN BOTH HAPTIC INSERTION AREAS AND WAS TORN/SPLIT (POSSIBLY CUT) INTO TWO PIECES. WHILE WE WERE UNABLE TO DETERMINE THE ORIGIN OF THE DAMAGE, OUR OBSERVATIONS REASONABLY SUGGEST THE DAMAGE IS NOT MANUFACTURING RELATED. PRODUCT HISTORY RECORDS WERE REVIEWED AND ALL DOCUMENTS INDICATE THE PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. NO FURTHER INFO IS EXPECTED. (B)(4).

    Description of Event or Problem · 1

    AN ASSISTANT REPORTED THAT ONE DAY FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, THE SURGEON NOTICED THAT THE HAPTICS BROKE INSIDE THE PT'S EYE. THE SURGERY WAS DESCRIBED AS A "TRAUMATIC CATARACT". THE SURGEON EXCHANGED THE IOL FOR A DIFFERENT MODEL LENS. IT WAS REPORTED THAT THE PT'S CURRENT CONDITION IS "GOOD". NO FURTHER INFO IS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TYPE 7B POSTERIOR CHAMBER, IOL, POLYMETHYLMETHACRYLATE HQL ALCON RESEARCH, LTD. / HUNTINGTON TYPE7B 11021351

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Required Intervention