BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 2023677 · Received March 3, 2011

    Report

    Report Number
    1119421-2011-00262
    Event Type
    Other
    Date Received
    March 3, 2011
    Date of Event
    January 1, 2011
    Report Date
    February 11, 2011
    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
    MI, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. ROOT CAUSE: NO ROOT CAUSE COULD BE IDENTIFIED BY THE INVESTIGATION. NO SAMPLE WAS RETURNED. ACTION TAKEN: NO FURTHER ACTION IS WARRANTED AT THIS TIME. COMPLAINT TRENDS WILL CONTINUE TO BE MONITORED AND FURTHER ACTION WILL BE INITIATED WHEN DEEMED NECESSARY BY THE APPROPRIATE RESPONSIBLE MANAGEMENT PERSONNEL. THERE HAVE BEEN NO OTHER SIMILAR COMPLAINTS REPORTED IN THE LOT NUMBER. AT THE REQUEST OF THE CONSUMER, THE SURGEON WAS NOT CONTACTED. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER'S WIFE REPORTED THAT AT A RECENT EYE EXAMINATION, HER HUSBAND WAS TOLD THAT HIS INTRAOCULAR LENS (IOL) HAD TURNED AMBER AND HAD NUMEROUS SPECKLES. THESE "SPECKLES RESULTED IN REFRACTING THE LIGHT ENTERING HIS EYE RESULTING IN POOR VISION". IN A FOLLOW UP PHONE CALL WITH THE CONSUMER, HE REPORTED HIS LENS WAS IMPLANTED SEVEN YEARS AGO. SOON AFTER HIS IOL IMPLANT PROCEDURE, HE NOTED OBJECTS ON A BRIGHT BACKGROUND WERE HARD TO SEE AND HAD A STARBURST AFFECT TO THEM. HIS VISION WAS FUZZY. THE CONSUMER SOUGHT A SECOND OPINION AND WAS TOLD THE LENS HAD TURNED AMBER IN COLOR AND HAD SPECKLES IN IT WHICH MIGHT BE CAUSING HIS VISUAL ISSUES. AT THE REQUEST OF THE CONSUMER, THE SURGEON WAS NOT CONTACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN60AT 776970

    Patients

    Seq Age Sex Outcome Treatment
    1 Other