BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 2163655 · Received June 10, 2011

    Report

    Report Number
    1119421-2011-00739
    Event Type
    Other
    Date Received
    June 10, 2011
    Date of Event
    May 11, 2011
    Report Date
    May 13, 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
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION: 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. AT THE CONSUMER'S REQUEST, THE SURGEON WAS NOT CONTACTED. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER'S FRIEND REPORTED THAT FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERIES, THE CONSUMER HAS A CONCERN ABOUT THE LENSES. IN A FOLLOW-UP WITH THE CONSUMER, SHE REPORTED EXPERIENCING BLURRY VISION SINCE DAY ONE OF HER IMPLANT SURGERIES FOR BOTH EYES. SHE REPORTED THE NEED FOR READERS WHICH IS WHAT SHE EXPECTED THE LENSES TO ELIMINATE. THE SURGEON TOLD HER THE CAPSULAR BAGS IN BOTH EYES HAD A WRINKLE AND THAT THIS WAS THE CAUSE OF HER VISION PROBLEMS AND IT WOULD RESOLVE WITH TIME. THE CONSUMER STATED THAT SHE WOULD GIVE HER EYES MORE TIME TO HEAL AS ADVISED BY HER SURGEON. AT THE CONSUMER'S REQUEST, THE SURGEON WAS NOT CONTACTED. 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 SN6AD1 12001632

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other THYROID MEDICATION