BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 818939 · Received February 2, 2007

    Report

    Report Number
    1119421-2007-00034
    Event Type
    Other
    Date Received
    February 2, 2007
    Date of Event
    January 1, 2005
    Report Date
    January 12, 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
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE ASSOCIATED WITH THIS REPORT HAS NOT BEEN RECEIVED FOR EVALUATION. THE DEVICE REMAINS IMPLANTED. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTER DID NOT PROVIDE A LENS SERIAL NUMBER, LOT NUMBER, OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION.

    Description of Event or Problem · 1

    THE SOURCE OF THIS EVENT IS A PUBLISHED JOURNAL ARTICLE. A COPY OF THE ARTICLE HAS BEEN PROVIDED WITH THIS REPORT. AFTER PLACEMENT OF THE IOL IN THE BAG, THE EDGE OF THE OPTIC WAS SEEN TO HAVE A FULL THICKNESS EDGE CHIP AND THE FRAGMENT WAS HANGING LOOSE FROM THE EDGE. THE CHIP WAS SUCCESSFULLY REMOVED INTRAOPERATIVELY WITH FORCEPS. THE AUTHOR REPORTS THAT SIX MONTHS FOLLOWING SURGERY, THE PT COMPLAINED OF GLARE DUE TO POSTERIOR CAPSULAR FOLDS ORIGINATING FROM THE SITE OF THE IOL DEFECT. THE PT'S UNCORRECTED VA IN THIS EYE WAS 20/20. THE PT WAS ADVISED, HOWEVER, REFUSED TO UNDERGO ND: YAG LASER CAPSULOTOMY TO RELIEVE THE SYMPTOMS. THE AUTHOR CONCLUDES THAT THIS EVENT HIGHLIGHTS THE NECESSITY TO CHECK EACH IOL UNDER THE MICROSCOPE PRIOR TO INSERTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON LABORATORIES, INC/HUNTINGTON SN60AT UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other