BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 2191166 · Received July 29, 2011

    Report

    Report Number
    1119421-2011-00916
    Event Type
    Injury
    Date Received
    July 29, 2011
    Date of Event
    January 1, 2011
    Report Date
    June 30, 2011
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    MFK
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVAL: 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. 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. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADD'L INFO WAS REQUESTED 07/01/2011, 07/05/2011 AND 07/11/2011 BY PHONE, FAX AND MAIL. ADD'L INFO WAS REC'D 07/05/2011 BY PHONE. A COMPLETED QUESTIONNAIRE HAS NOT BEEN REC'D. (B)(4).

    Description of Event or Problem · 1

    A PURCHASING COORDINATOR REPORTED THAT FIVE INTRAOCULAR LENSES HAVE BEEN EXPLANTED IN THE CURRENT YR DUE TO HYPEROPIC SURPRISES. ALL PTS ARE DOING WELL AND ARE HAPPY WITH THE OUTCOME FOLLOWING THE EXCHANGES. ADD'L INFO HAS BEEN REQUESTED. THERE ARE FIVE MEDICAL REPORTS ASSOCIATED WITH THESE EVENTS; THIS REPORT IS FOR THE SECOND PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTROCULAR LENS MFK ALCON RESEARCH, LTD. / HUNTINGTON SN6AD1 11022509

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention