BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 2163606 · Received June 8, 2011

    Report

    Report Number
    1119421-2011-00701
    Event Type
    Other
    Date Received
    June 8, 2011
    Date of Event
    January 1, 2006
    Report Date
    May 9, 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
    TX, 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: THE ROOT CAUSE COULD NOT 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 ON 05/10/2011, 05/11/2011, AND 05/24/2011 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    FOUR YEARS FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERIES, A CONSUMER REPORTED SHE HAS NOT BEEN ABLE TO SEE SINCE THE FIRST EYE WAS DONE. SHE REPORTED HER VISION HAS BEEN WORSE THAN BEFORE HER IMPLANT PROCEDURES. THE CONSUMER STATED HER SURGEON TELLS HER THAT THE LENSES LOOK FINE AND THERE IS NOTHING MORE THEY CAN DO. SHE HAS TRIED FIVE PAIRS OF GLASSES AND NONE OF THEM CORRECT HER PROBLEM. ADD'L INFO HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD / HUNTINGTON SN60D3 983329

    Patients

    Seq Age Sex Outcome Treatment
    1 Other