BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 1070713 · Received July 3, 2008

    Report

    Report Number
    1119421-2008-00501
    Event Type
    Other
    Date Received
    July 3, 2008
    Date of Event
    May 1, 2008
    Report Date
    June 3, 2008
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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 06/03/2008, 06/10/2008, AND 06/26/2008 VIA PHONE AND 06/06/2008 VIA FAX AND MAIL. THIS REPORT WAS MAILED TO FDA ON: 07/03/2008.

    Description of Event or Problem · 1

    THE SURGEON REPORTED A PATIENT EXPERIENCED MYOPIC SURPRISE IN THE LEFT EYE FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. 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 SN60WF 10813478

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other