BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1172738 · Received September 17, 2008

    Report

    Report Number
    1119421-2008-00717
    Event Type
    Other
    Date Received
    September 17, 2008
    Report Date
    August 18, 2008
    Manufacturer
    ALCON RESEARCH, LTD.
    Product Code
    MFK
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 COULD NOT BE REVIEWED BECAUSE THE REPORTER DID NOT PROVIDE A LENS SERIAL NUMBER, LOT NUMBER, OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. ADDITIONAL INFORMATION WAS REQUESTED 08/21/2008, 08/26/2008, 08/28/2008, 09/02/2008 AND 09/04/2008 BY MAIL, FAX AND PHONE. ADDITIONAL INFORMATION WAS RECEIVED 09/02/2008 BY PHONE. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED.

    Description of Event or Problem · 1

    A CONSUMER REPORTS SEEING A DARK SEMI-CIRCLE IN THE PERIPHERY OF HER VISION FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. IN A FOLLOW-UP, SHE ALSO REPORTS THAT HER EYE IS RED, HER NEAR VISION IS NOT FOCUSED, SHE HAS HEADACHES AND SHE SEES MOVING BLACK LINES AND FLICKERING LIGHTS. THE SURGEON REPORTS THAT THE CONSUMER HAS SOME RESIDUAL ASTIGMATISM AND HE BELIEVES THE DARK SHAPE IN HER PERIPHERAL VISION IS ACTUALLY THE EDGE OF THE IOL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other