BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 1760644 · Received July 14, 2010

    Report

    Report Number
    1119421-2010-00817
    Event Type
    Injury
    Date Received
    July 14, 2010
    Date of Event
    January 1, 2010
    Report Date
    May 13, 2010
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LENS WAS RETURNED FOR ANALYSIS AND WAS VERIFIED TO HAVE SIGNS OF HANDLING. BOTH HAPTICS WERE BENT-GUSSET AND DISTAL AREA ADHERED TO THE ANTERIOR OPTIC SURFACE. THE OPTIC WAS TORN/SPLIT/CRACKED AGAINST A POST OF THE LENS CASE. WHILE WE WERE UNABLE TO DETERMINE THE ORIGIN OF THE DAMAGE, OUR OBSERVATIONS REASONABLY SUGGEST THE DAMAGE IS NOT MFG RELATED. PRODUCT HISTORY RECORDS WERE REVIEWED FOR THE LENS AND ALL DOCUMENTS INDICATE THE PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFO WAS REQUESTED ON 07/02/2010 AND 07/09/2010 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "CAPSULE BROKE" (CAPSULE BAG TEAR, POSTERIOR). PRODUCT PROBLEM(S): "NONE REPORTED" (NO INFO [IOL (INTRAOCULAR LENS) IMPLANT]). A PURCHASING AGENT REPORTED THAT A LENS WAS NOT USED. IN A FOLLOW-UP, A NURSE EXPLANTED THAT THE PT'S CAPSULE BROKE SO THE LENS WAS NOT USED. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN60WF 10922068

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other MONARCH DELIVERY SYSTEM (UNK LOT AND SERIAL #)