BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 1033364 · Received April 24, 2008

    Report

    Report Number
    1119421-2008-00271
    Event Type
    Injury
    Date Received
    April 24, 2008
    Date of Event
    January 1, 2008
    Report Date
    March 25, 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
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROD WAS RETURNED FOR ANALYSIS AND WAS VERIFIED TO HAVE SIGNS OF HANDLING. ONE HAPTIC WAS BENT IN THE GUSSET REGION. THE ANTERIOR OPTIC SURFACE WAS SCRATCHED. THE OPTICAL RESOLUTION WAS ACCEPTABLE; FOCAL LENGTH READING WAS 20.25 EQUALING A 19.5 DIOPTER. WHILE WE WERE UNABLE TO DETERMINE THE ORIGIN OF THE DAMAGE, OUR OBSERVATIONS REASONABLY SUGGEST THE DAMAGED IS NOT MFG RELATED. THE PROD HISTORY RECORDS WERE REVIEWED AND ALL DOCUMENTS INDICATE THE PROD MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REC'D IN THE LOT #. ADD'L INFO WAS REQUESTED 03/24/2008, 04/04/2008 AND 04/07/2008 BY MAIL, FAX AND PHONE. A COMPLETED QUESTIONNAIRE HAS NOT BEEN REC'D. THIS REPORT WAS MAILED TO FDA ON: 04/24/2008.

    Description of Event or Problem · 1

    A SURGEON REPORTS THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, A PT REPORTED NEGATIVE DYSPHOTOPSIA. THE LENS WAS EXCHANGED. ADD'L 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 10765814

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention