BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1211511 · Received October 17, 2008

    Report

    Report Number
    1119421-2008-00813
    Event Type
    Other
    Date Received
    October 17, 2008
    Date of Event
    September 1, 2008
    Report Date
    September 18, 2008
    Manufacturer
    ALCON RESEARCH, LTD.
    Product Code
    MFK
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; THE DEVICE REMAINS IMPLANTED. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED.

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT HE SEES THREE IMAGES INSTEAD OF ONE FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE SURGEON STATES THAT EVERYTHING LOOKS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD. SN6AD3 10740081

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other