BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1058178 · Received June 6, 2008

    Report

    Report Number
    1119421-2008-00413
    Event Type
    Other
    Date Received
    June 6, 2008
    Date of Event
    January 1, 2008
    Report Date
    May 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
    FL, 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 INFO WAS REQUESTED 05/08/2008, 05/13/2008 AND 05/29/2008 BY PHONE, FAX AND MAIL. ADDITIONAL INFO WAS RECEIVED 05/08/2008. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. THIS REPORT WAS MAILED TO FDA ON: 06/06/2008.

    Description of Event or Problem · 1

    A SURGEON REPORTS HAVING A PT WITH A DECENTERED LENS FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE PATIENT'S VISUAL ACUITY HAS DECREASED AND THE PT REPORTS BLURRED VISION THAT IS BETTER WHEN HE TILTS HIS HEAD TO THE SIDE. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD./HUNTINGTON SN6AD3 10751329

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other