BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 968259 · Received December 19, 2007

    Report

    Report Number
    1119421-2007-00549
    Event Type
    Injury
    Date Received
    December 19, 2007
    Report Date
    November 19, 2007
    Manufacturer
    ALCON LABORATORIES, INC/HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE COMPLAINT DEVICE WAS NOT RETURNED FOR EVALUATION. PRODUCT HISTORY RECORDS WERE REVIEWED AND INDICATE THE PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED FOR THIS LOT OF PRODUCT. THIS REPORT WAS MAILED TO THE FDA ON: 12/19/2007. ADDITIONAL INFORMATION REQUESTED FROM THE FACILITY ON 11/19/2007, 11/20/2007 AND 11/30/2007.

    Description of Event or Problem · 1

    A USER FACILITY REPORTS, A TORN CAPSULE DURING INTRAOCULAR LENS IMPLANT SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON LABORATORIES, INC/HUNTINGTON MA60AC 10722929

    Patients

    Seq Age Sex Outcome Treatment
    1 NI YR Required Intervention