BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1083557 · Received July 25, 2008

    Report

    Report Number
    1119421-2008-00559
    Event Type
    Other
    Date Received
    July 25, 2008
    Date of Event
    June 11, 2008
    Report Date
    June 20, 2008
    Manufacturer
    ALCON RESEARCH , LTD./HUNTINGTON
    Product Code
    MFK
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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. ADDITIONAL INFORMATION WAS REQUESTED ON 06/20/2008 AND 07/16/2008 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 07/18/2008.

    Description of Event or Problem · 1

    AN OPTOMETRIST REPORTED THAT, SIX MONTHS FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERY, FLECKS WERE OBSERVED ON THE LENSES. IN A FOLLOW-UP, THE OPTOMETRIST STATES THE PATIENT REPORTS BLURRY VISION AT DISTANCE AND NEAR AND HAS "DIFFICULTY WITH SMALL PRINT AND CRAWLERS ON TV". THERE ARE TWO MEDICAL DEVICE REPORTS FOR THIS EVENT. 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 SN60D3 896771

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other