BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 732971 · Received July 7, 2006

    Report

    Report Number
    1119421-2006-00238
    Event Type
    Injury
    Date Received
    July 7, 2006
    Date of Event
    May 18, 2006
    Report Date
    June 9, 2006
    Manufacturer
    ALCON LABORATORIES, INC / HUNTINGTON
    Product Code
    HQL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE RETURNED INTRAOCULAR LENS WAS EXAMINED AND VERIFIED TO HAVE SIGNS OF HANDLING. THE LENS OPTIC SCRATCHED. A LENS BENCH EXAMINATION COULD NOT BE CONDUCTED DUE TO THE EXTENT OF OPTIC DAMAGE. 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 RECEIVE FOR THIS LOT NUMBER. THE MANUFACTURER'S INTERNAL REFERENCE NUMBER IS: ID062328 THIS REPORT WAS MAILED TO THE FDA ON: 07/07/2006 THIS IMFORMATION IS SUBMITTED PURSUANT TO 21 CRF803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN ALCON LABORATORIES, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.

    Description of Event or Problem · 1

    A SURGEON REPORTED PERFORMING AN INTRAOCULAR LENS EXCHANGE DUE TO AN UNEXPECTED POSTOPERATIVE REFRACTION. THE PATIENT DEVELOPED TOXIC ANTERIOR SEGMENT SYSNDROME (TASS) DURING THE FIRST 24 HOURS FOLLOWING THE LENS EXCHANGE. THE PATIENT IS BEING TREATED WITH A TOPICAL ANTIBIOTIC AND STEROID. VITREOUS CULTURES WERE NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON LABORATORIES, INC / HUNTINGTON SA60AT 716977

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention VISCOAT