BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 831228 · Received March 21, 2007

    Report

    Report Number
    1119421-2007-00097
    Event Type
    Injury
    Date Received
    March 21, 2007
    Date of Event
    December 20, 2006
    Report Date
    February 19, 2007
    Manufacturer
    ALCON LABORATORIES, INC. / HUNTINGTON
    Product Code
    HQL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE RETURNED INTRAOCULAR LENS WAS EXAMINED AND VERIFIED TO HAVE SIGNS OF HANDLING. THE CENTER OF THE OPTIC WAS SCRATCHED. 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 RECEIVED FOR THIS LOT NUMBER. ADD'L INFO WAS REQUESTED BY MAIL AND BY FAX ON 02/20/2007. PHONE FOLLOW-UP WAS CONDUCTED ON 02/20/2007 AND 03/05/2007. A COMPLETED QUESTIONNAIRE WAS RECEIVED 03/19/2007.

    Description of Event or Problem · 1

    A USER FACILITY REPORTED A LENS WAS REMOVED DUE TO A SCRATCH. FOLLOW-UP INFORMATION PROVIDED ON A RETURNED QUESTIONNAIRE, RECEIVED ON 03/19/2007, INDICATED A LENS EXCHANGE WAS PERFORMED TWO WEEKS FOLLOWING THE INITIAL SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON LABORATORIES, INC. / HUNTINGTON SN60WF 122675

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention