BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 2103746 · Received May 19, 2011

    Report

    Report Number
    1119421-2011-00593
    Event Type
    Other
    Date Received
    May 19, 2011
    Date of Event
    March 28, 2011
    Report Date
    April 19, 2011
    Manufacturer
    ALCON RESEARCH LTD./HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    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: THE ROOT CAUSE COULD NOT BE IDENTIFIED BY THE INVESTIGATION. THE SAMPLE WAS NOT RETURNED. ACTION TAKEN: INVESTIGATION HAS BEEN COMPLETED BASED ON CURRENT INFORMATION. CONCLUSION: BASED ON OUR CURRENT TRACKING, THERE ARE NO ADVERSE TRENDS FOR THIS REPORTED COMPLAINT AND BASED ON THESE FINDINGS THE RESIDUAL RISK REMAINS UNCHANGED AND AT AN ACCEPTABLE LEVEL. 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 SIX PATIENTS WITH SOMETHING LIKE PROLIFERATIVE TISSUES AROUND THE CONTINUOUS CURVILINEAR CAPSULORHEXIS (CCC) ON THE ANTERIOR LENS OPTIC TWO MONTHS FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THERE WAS NO IMPACT ON THE VISUAL FUNCTION OF THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE SIX MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS IS THE FOURTH OF SIX REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH LTD./HUNTINGTON SN60WF 12000916

    Patients

    Seq Age Sex Outcome Treatment
    1 Other