BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF

    MDR report key: 3112090 · Received May 7, 2013

    Report

    Report Number
    1119421-2013-00510
    Event Type
    Malfunction
    Date Received
    May 7, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 11, 2013
    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
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. NO ROOT CAUSE COULD BE IDENTIFIED BY THE INVESTIGATION. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERIES, THE PATIENT PRESENTED WITH GLISTENINGS IN ONE OF THE LENSES. THE GLISTENINGS WERE DESCRIBED AS UNUSUAL AND "EXCESSIVELY IMPORTANT." THE SURGEON PROVIDED PRODUCT IDENTIFIERS FOR BOTH IOLS; HOWEVER, HE DID NOT SPECIFY WHICH IOL HAD THE GLISTENINGS. IT IS ALSO UNKNOWN WHETHER THERE WERE ADVERSE EVENTS TO THE PATIENT AS A RESULT OF THE IOL GLISTENINGS. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE FIRST LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197769 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON MA60AC 12184341

    Patients

    Seq Age Sex Outcome Treatment
    1