BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 1023601 · Received March 28, 2008

    Report

    Report Number
    1119421-2008-00184
    Event Type
    Other
    Date Received
    March 28, 2008
    Date of Event
    February 29, 2008
    Report Date
    February 29, 2008
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; THE DEVICE REMAINS IMPLANTED. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED. THIS REPORT WAS MAILED TO FDA ON: 03/28/2008.

    Description of Event or Problem · 1

    A SURGEON REPORTS THAT FOLLOWING INTRAOCULAR LENS IMPLANT SURGERY, A PT REPORTED DIFFICULTY DRIVING AT NIGHT. HE STATES THAT AT TIMES, IT SEEMS SOMETHING IS COVERING HIS SIGHT FOR A FEW SECONDS. OTHERWISE, HE REPORTS GOOD DISTANCE AND NEAR VISUAL ACUITIES. UPON EXAMINATION, THE SURGEON NOTICED A FINE LAYER OF SPOTS IN THE LENS, MOSTLY ON THE POSTERIOR SURFACE, AND DESCRIBES THE LENS SURFACE AS OPAQUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON MA50BM 641642

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other