BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1022538 · Received March 27, 2008

    Report

    Report Number
    1119421-2008-00189
    Event Type
    Other
    Date Received
    March 27, 2008
    Date of Event
    January 1, 2007
    Report Date
    February 26, 2008
    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
    NC, US
    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. AT THE CONSUMER'S REQUEST, THE SURGEON WAS NOT CONTACTED.

    Description of Event or Problem · 1

    A CONSUMER REPORTED SEEING HALOS AROUND LIGHTS, SHADOWS BEHIND WORDS AND BLURRY INTERMEDIATE VISION FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERY. AT THE CONSUMER'S REQUEST, THE SURGEON WAS NOT CONTACTED. THIS IS ONE OF TWO MEDWATCH REPORTS BEING FILED FOR THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCUAR LENS MFK ALCON RESEARCH, LTD. / HUNTINGTON SN6AD3 10736900

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other RESTASIS