BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 1172746 · Received September 17, 2008

    Report

    Report Number
    1119421-2008-00715
    Event Type
    Other
    Date Received
    September 17, 2008
    Date of Event
    March 1, 2008
    Report Date
    August 18, 2008
    Manufacturer
    ALCON RESEARCH, LTD/HUNTINGTON
    Product Code
    MFK
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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 08/19/2008, 08/21/2008, 08/26/2008, 09/03/2008 AND 09/08/2008 BY MAIL, FAX AND PHONE. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED.

    Description of Event or Problem · 1

    A CONSUMER REPORTS EXPERIENCING SEEING BROWN DOTS, FUZZY VISION AND GLARE (ESPECIALLY AT NIGHT) FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE CONSUMER WAS EXAMINED BY A RETINAL SPECIALIST AND WAS TOLD THAT HE HAD A MACULAR PUCKER. HE HAS ALSO HAD A FLUORESCEIN ANGIOGRAM PERFORMED AND WAS TOLD THAT HE HAD A PUCKER. THE SURGEON DOES NOT BELIEVE THESE EVENTS ARE LENS RELATED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THESE EVENTS. THIS REPORT IS FOR THE RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS MFK ALCON RESEARCH, LTD/HUNTINGTON SN60WF 10757966

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other