BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF TORIC

    MDR report key: 1220518 · Received October 29, 2008

    Report

    Report Number
    1119421-2008-00846
    Event Type
    Other
    Date Received
    October 29, 2008
    Date of Event
    January 1, 2008
    Report Date
    September 29, 2008
    Manufacturer
    ALCON RESEARCH LTD./HUNTINGTON
    Product Code
    MJP
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 BY PHONE ON 09/29/2008 AND 10/01/2008 AND BY MAIL ON 10/21/2008. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED.

    Description of Event or Problem · 1

    A FRIEND OF THE CONSUMER REPORTED THAT THE CONSUMER EXPERIENCED DISTORTED VISION IN HIS RIGHT EYE A FEW HOURS AFTER INTRAOCULAR LENS (IOL) IMPLANT SURGERY AND HIS VISION REMAINS DISTORTED SEVERAL MONTHS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF TORIC INTRAOCULAR LENS MJP ALCON RESEARCH LTD./HUNTINGTON SN60T3 10715732

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other