BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 1079085 · Received July 18, 2008

    Report

    Report Number
    1119421-2008-00534
    Event Type
    Other
    Date Received
    July 18, 2008
    Date of Event
    April 1, 2008
    Report Date
    June 18, 2008
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 THIS LOT NUMBER. ADDITIONAL INFORMATION WAS REQUESTED ON 06/18/2008 AND 07/03/2008 BY PHONE, ON 06/19/2008 BY MAIL AND FAX AND ON 06/30/2008 BY EMAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. THIS REPORT WAS MAILED TO FDA ON: 07/18/2008.

    Description of Event or Problem · 1

    A SURGEON REPORTED A PATIENT EXPERIENCED NEGATIVE DYSPHOTOPSIA FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. IT WAS REPORTED THAT THE PATIENT STATED SHE SEES A GRAYISH ARC IN HER TEMPORAL VISION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN60AT 962851

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other