BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 1230258 · Received November 7, 2008

    Report

    Report Number
    1119421-2008-00891
    Event Type
    Other
    Date Received
    November 7, 2008
    Date of Event
    October 1, 2008
    Report Date
    October 10, 2008
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    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. AT THE REPORTER'S REQUEST, THE SURGEON WAS NOT CONTACTED.

    Description of Event or Problem · 1

    A CONSUMER'S DAUGHTER REPORTS THAT, FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, HER MOTHER EXPERIENCED DOUBLE VISION, SAW "GOGGLES" ON PEOPLE ON THE TV, AND SAW "THINGS IN THE REFRIGERATOR THAT HAD A CRINKLED APPEARANCE". AT THE REPORTER'S REQUEST, THE SURGEON WAS NOT CONTACTED. IN A FOLLOW-UP, THE DAUGHTER REPORTS THAT HER MOTHER'S DOUBLE VISION HAS GONE AWAY AND HER VISION IS BETTER. SHE STILL SEES THE DISTORTION, BUT THE DOCTORS TOLD HER THIS WAS SECONDARY TO THE MACULAR DEGENERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN60WF 10837027

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Other