BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 1220570 · Received October 31, 2008

    Report

    Report Number
    1119421-2008-00866
    Event Type
    Other
    Date Received
    October 31, 2008
    Date of Event
    January 1, 2008
    Report Date
    October 1, 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
    AK, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROD WAS NOT RETURNED FOR ANALYSIS; THE DEVICE REMAINS IMPLANTED. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PROD MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. AT THE CONSUMER'S REQUEST, THE SURGEON WAS NOT CONTACTED. THIS REPORT WAS MAILED TO FDA ON: 10/31/2008.

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT, FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERY, SHE SEES A BROWN WAVY LINE ACROSS HER VISION THAT COMES AND GOES WHEN SHE IS READING; AND SHE SEES SOMETHING MOVING IN THE PUPIL THAT APPEARS SILVER OR GRAY. SHE ALSO STATED THAT HER VISION HAS IMPROVED SINCE HER SURGERY. AT THE CONSUMER'S REQUEST, THE SURGEON WAS NOT CONTACTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON SN60WF 10803796

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other