BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1230202 · Received November 13, 2008

    Report

    Report Number
    1119421-2008-00914
    Event Type
    Injury
    Date Received
    November 13, 2008
    Report Date
    October 14, 2008
    Manufacturer
    ALCON RESEARCH, LTD/HUNTINGTON
    Product Code
    MFK
    PMA / PMN Number
    P040020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    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. AT THE REQUEST OF THE CONSUMER, THE SURGEON WAS NOT CONTACTED FOR ADDITIONAL INFO. NO ADDITIONAL INFO IS EXPECTED. THIS REPORT WAS MAILED TO FDA ON: 11/13/2008.

    Description of Event or Problem · 1

    A CONSUMER REPORTED EXPERIENCING UNCLEAR VISION AND OCCASIONAL BLURRY DISTANCE VISION, FOLLOWING BILATERAL IOL IMPLANT SURGERY. SHE REPORTED SHE COULD SEE PRETTY WELL AFTER THE SURGERY; HOWEVER, HER INTRAOCULAR PRESSURE INCREASED SIGNIFICANTLY AND HER DR HAD TO "DRAIN' EYES TO LOWER THE PRESSURE. SHE STATED SHE HAS AN OCULAR HISTORY OF GLAUCOMA. AT THE CONSUMER'S REQUEST, HER SURGEON WAS NOT CONTACTED FOR ADDITIONAL INFO. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THESE EVENTS. 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 SA60D3 889844

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention