BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1230245 · Received November 7, 2008

    Report

    Report Number
    1119421-2008-00882
    Event Type
    Other
    Date Received
    November 7, 2008
    Date of Event
    January 1, 2008
    Report Date
    October 9, 2008
    Manufacturer
    ALCON MANUFACTURING, LTD./ HUNTINGTON
    Product Code
    MFK
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE ASSOCIATED WITH THIS REPORT HAS NOT BEEN RECEIVED FOR EVALUATION. THE DEVICE REMAINS IMPLANTED. PRODUCT HISTORY RECORDS WERE REVIEWED AND ALL DOCUMENTS INDICATE THE PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS RECEIVED IN THE LOT NUMBER. AT THE PT'S REQUEST, THE SURGEON WAS NOT CONTACTED.

    Description of Event or Problem · 1

    A CONSUMER REPORTED BLURRY NEAR VISION AFTER INTRAOCULAR LENS (IOL) IMPLANT SURGERY. AT THE PT'S REQUEST, THE SURGEON WAS NOT CONTACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON MANUFACTURING, LTD./ HUNTINGTON SN6AD3 10752390

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other