BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 732959 · Received July 7, 2006

    Report

    Report Number
    1119421-2006-00237
    Event Type
    Injury
    Date Received
    July 7, 2006
    Date of Event
    February 23, 2006
    Report Date
    June 8, 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
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE RETURNED INTRAOCULAR LENS WAS EXAMINED AND VERIIED TO HAVE SIGNS OF HADNLING. ONE HAPTIC WAS BROKEN IN THE GUSSET AREA (RETURNED) AND THE OPTIC WAS TORN/SPLIT/CRACKED ON A A POST OF THE LENS CASE. NUMBEROUS SHORT BLUE FIBERS WERE VISIBLE ON THE LENS, INSIDE AND OUTSIDE THE WELL AREA OF THE LENS CASE (POSSIBLY SUTURE MATERIAL). WHILE WE WERE UNABLE TO DETERMINE THE ORIGIN OF THE DAMAGE, OUR OBSERVATIONS REASONABLY SUGGEST THE DAMAGE IS NOT MANUFACTURING RELATED. UPON ERTURN, THE LENS WAS OBSERVED TO BE IMPROPERLY RE-CASED BY THE CUSTOMER RESULTING IN OPTIC DAMAGE. THERE HAVE BEEN NO OTHER COMPLAINTS RECEIVED FOR THIS LOT NUMBER. THIS INFORMATION IS SUBMITTED PURSUANT TO 21CRF803, 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 NURSE FROM THE USER FACILITY REPORTS THE SURGEON DID NOT LIKE THE POSITION OF THE INTRAOCULAR LENS FOLLOWING INSERTION AND DECIDED TO REMOVED IT. A VITRECTOMY WAS PERFORMED AND ANOTHER LENS MODEL WAS INSERTED. 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 SN60WF 884247

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention