BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 2180904 · Received July 22, 2011

    Report

    Report Number
    1119421-2011-00910
    Event Type
    Injury
    Date Received
    July 22, 2011
    Date of Event
    May 11, 2011
    Report Date
    June 24, 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
    ME, US
    Reporter Occupation
    OTHER

    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. ADDITIONAL INFO WAS REQUESTED ON 06/27/2011 AND 06/30/2011 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 07/12/2011. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT APPROXIMATELY SIX WEEKS FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, A PT IS DISAPPOINTED WITH THE OUTCOME DUE TO POOR NEAR VISION. IN A F/U, THE OPTHALMIC ASSISTANT REPORTED RELAXING INCISION WITH YAG WAS PERFORMED EIGHT DAYS FOLLOWING THE IMPLANT SURGERY AND THE EVENT CONTINUES. IN THE SURGEON'S OPINION, IT IS UNK IF THE DEVICE CAUSED/CONTRIBUTED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD. / HUNTINGTON SN6AD1 12016166

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention VISCOAT| HEALON| MONARCH III HANDPIECE AND D CARTRIDGE