BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 1132623 · Received August 22, 2008

    Report

    Report Number
    1119421-2008-00625
    Event Type
    Injury
    Date Received
    August 22, 2008
    Date of Event
    January 1, 2008
    Report Date
    July 24, 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
    SD, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE ASSOCIATED WITH THIS REPORT HAS NOT BEEN RECEIVED FOR EVAL. PROD HISTORY RECORDS WERE REVIEWED AND ALL DOCUMENTS INDICATE THE PROD MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS RECEIVED IN THE LOT NUMBER. ADD'L INFO WAS REQUESTED BY MAIL AND FAX ON 08/28/2008 AND BY PHONE ON 7/25/2008 AND 06/07/2008. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. THIS REPORT WAS MAILED TO FDA ON: 08/22/2008.

    Description of Event or Problem · 1

    A USER FACILITY REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, THE CAPSULAR BAG RUPTURED. ADD'L INFO REQUESTED HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN60WF 10751786

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention