BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF

    MDR report key: 2246475 · Received August 19, 2011

    Report

    Report Number
    1119421-2011-01010
    Event Type
    Malfunction
    Date Received
    August 19, 2011
    Date of Event
    January 1, 2011
    Report Date
    July 20, 2011
    Manufacturer
    ALCON RESEARCH, LTD/HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVAL: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. THE PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MFG DOCUMENTATION. ROOT CAUSE: THE ROOT CAUSE CANNOT BE DETERMINED. NOT ENOUGH INFO WAS PROVIDED FROM THE ACCOUNT TO PROPERLY COMPLETE AN INVESTIGATION. ACTION TAKEN: INVESTIGATION HAS BEEN COMPLETED BASED ON CURRENT INFO. 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. ADD'L INFO WAS REQUESTED 7/21/2011 AND 8/3/2011 BY FAX, MAIL AND PHONE. ADD'L INFO WA RECEIVED 8/9/2011 BY MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED HAVING A PT WHOSE INTRAOCULAR LENS (IOL) HAS DEVELOPED GLISTENINGS. NEITHER THE SURGEON NOR THE PT HAS ANY COMPLAINTS. ADD'L INFO WAS RECEIVED FROM THE SURGEON, WHO REPORTS THAT THE PT HAS DEVELOPED SOME POSTERIOR CAPSULAR OPACITY. ADD'L INFO HAS BEEN REQUESTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1