BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1002944 · Received February 7, 2008

    Report

    Report Number
    1119421-2008-00045
    Event Type
    Other
    Date Received
    February 7, 2008
    Date of Event
    January 1, 2007
    Report Date
    January 8, 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
    AZ, 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. ADDITIONAL INFORMATION WAS REQUESTED 01/15/2008, 01/16/2008, 01/18/2008 AND 01/19/2008 BY MAIL, FAX AND PHONE. PATIENT RECORDS WERE RECEIVED 01/11/2008. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED.

    Description of Event or Problem · 1

    A CONSUMER REPORTS BLURRY NEAR AND DISTANCE VISION, HALOS, AND A HALF-MOON SHAPE IN HIS PERIPHERAL VISION FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. HE SAW ANOTHER SURGEON FOR A SECOND OPINION AND WAS GIVEN A PRESCRIPTION FOR EYEGLASSES. HE STATES THAT WHEN HE WEARS THE GLASSES, EVERYTHING LOOKS ANIMATED. IN A FOLLOW-UP, THE SURGEON REPORTS THE CONSUMER MAY HAVE CONTRAST AND SENSITIVITY ISSUES. THERE ARE TWO MANUFACTURER'S DEVICE REPORTS ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD. / HUNTINGTON SN60D3 10710035

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other