BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 2023725 · Received February 18, 2011

    Report

    Report Number
    1119421-2011-00165
    Event Type
    Other
    Date Received
    February 18, 2011
    Date of Event
    January 1, 2010
    Report Date
    January 19, 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
    CA
    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 COMPLIANCE OFFICER REPORTED 29 CASES OF "REFRACTILE INCLUSIONS" TERMED AS GLISTENINGS. THE GLISTENINGS ARE REPORTED TO BE AFFECTING THE QUALITY AND AMOUNT OF VISION IN THE PATIENTS INVOLVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE 29 MEDICAL DEVICE REPORTS ASSOCIATED WITH THESE EVENTS; THIS IS THE TWENTY-NINTH CASE. THIS PATIENT WAS BILATERALLY IMPLANTED. THIS REPORT IS FOR THE LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN60WF 957427

    Patients

    Seq Age Sex Outcome Treatment
    1 Other