BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 1120773 · Received August 15, 2008

    Report

    Report Number
    1119421-2008-00603
    Event Type
    Other
    Date Received
    August 15, 2008
    Date of Event
    July 16, 2008
    Report Date
    July 16, 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
    IL, 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. ADD'L INFO WAS REQUESTED ON 07/17/208, 07/18/2008, 07/21/2008, 07/24/2008 AND 07/29/2008 BY PHONE, MAIL AND FAX. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. THIS REPORT WAS MAILED TO FDA ON: 08/15/2008.

    Description of Event or Problem · 1

    A SURGEON REPORTED TWO PTS DEVELOPED TASS LIKE SYMPTOMS ONE DAY FOLLOWING INTRAOCULAR (IOL) IMPLANT SURGERY. THERE WAS NO PAIN OR DECREASE IN VISION. IN A FOLLOW UP PHONE CALL THE FACILITY STATED THE PT'S SYMPTOMS HAD IMPROVED AND THEY WERE NOT BLAMING THE IOL. THE CAUSE OF THE EVENT IS NOT KNOWN. ADD'L INFO HAS BEEN REQUESTED. THIS IS THE SECOND OF TWO MEDICAL DEVICE REPORTS BEING FILED FOR THIS REPORT. THIS REPORT IS FOR THE SECOND PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON SN60WF NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other DISCOVISC ON