BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 1051650 · Received May 21, 2008

    Report

    Report Number
    1119421-2008-00354
    Event Type
    Injury
    Date Received
    May 21, 2008
    Date of Event
    January 1, 2008
    Report Date
    March 27, 2008
    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
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR ANALYSIS AND WAS VERIFIED TO HAVE SIGNS OF HANDLING. ONE HAPTIC WAS TORN IN THE OUTER GUSSET AREA; HOWEVER, THE HAPTIC WAS STILL ATTACHED. BOTH HAPTICS WERE BENT-DISTAL AREA; HOWEVER, THE HAPTIC WAS STILL ATTACHED. BOTH HAPTICS WERE BENT-DISTAL AREA. THE OPTIC WAS SCRATCHED AND TORN/SPLIT/CRACKED INTO TWO PIECES (POSSIBLY CUT). 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 IN THE LOT NUMBER. ADDITIONAL INFORMATION WAS REQUESTED 04/21/2008 BY FAX AND MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED.

    Description of Event or Problem · 1

    A NURSE REPORTS THAT DURING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, A HAPTIC BROKE IN THE EYE. DURING REMOVAL, THE POSTERIOR CAPSULE BROKE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN60WF 10776498

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention