BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 2010724 · Received March 2, 2011

    Report

    Report Number
    1119421-2011-00212
    Event Type
    Injury
    Date Received
    March 2, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 31, 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
    BE
    Reporter Occupation
    OTHER

    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: 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 COMPLAINTS REPORTED IN THE LOT NUMBER. ADD'L INFO HAS BEEN REQUESTED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT TEN YEARS FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERY, A WHITE DISCOLORATION OF THE IOLS HAS BEEN OBSERVED. THE PT IS A TEACHER AND IS NOW UNABLE TO WORK DUE TO VISION LOSS. MANY EXAMS AND TESTS HAVE BEEN DONE TO FIND A CAUSE FOR THE DECREASED VISUAL ACUITY, BUT THE SURGEON'S FINAL CONCLUSION IS THE DISCOLORATION OF THE LENS. THE LENS WILL BE EXCHANGED. ADD'L INFO WAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT; THIS REPORT IS FOR THE FELLOW EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH. LTD. / HUNTINGTON MA30BA 586267

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other