BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF

    MDR report key: 1029864 · Received April 16, 2008

    Report

    Report Number
    1119421-2008-00252
    Event Type
    Malfunction
    Date Received
    April 16, 2008
    Date of Event
    March 13, 2008
    Report Date
    March 17, 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
    KS, US
    Reporter Occupation
    OTHER

    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. ADD'L INFO WAS REQUESTED 03/18/2008, 03/19/2008, 03/21/2008 AND 03/27/2008 BY PHONE, FAX AND MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED 03/26/2008.

    Description of Event or Problem · 1

    A SURGEON REPORTS THAT FIVE YEARS FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, A PT'S LENS HAS TURNED GREY. THE PT HAS ALSO HAD A MYOPIC SHIFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SA60AT 730850

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other