BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 2060903 · Received March 18, 2011

    Report

    Report Number
    1119421-2011-00286
    Event Type
    Other
    Date Received
    March 18, 2011
    Date of Event
    October 8, 2010
    Report Date
    February 18, 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
    JA
    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: 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 COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION HAS BEEN REQUESTED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT APPROXIMATELY FOUR YEARS FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, THE PATIENT'S VISUAL ACUITY HAS DECREASED AS BEFORE THE LENS WAS IMPLANTED. THE SURGEON ALSO NOTED "WHITISH MILKY CONDITION" ON THE SURFACE OF THE LENS OPTIC. IN A FOLLOW-UP, THE SURGEON REPORTED THE PATIENT HAS UVEITIS AND THE VISUAL ACUITY IS UNSTABLE. HE ALSO REPORTED THAT THE DECREASED VISUAL ACUITY MAY BE CAUSED BY THE WHITENING OF THE LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SA60AT 992110

    Patients

    Seq Age Sex Outcome Treatment
    1 Other