BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 1021096 · Received March 27, 2008

    Report

    Report Number
    1119421-2008-00187
    Event Type
    Injury
    Date Received
    March 27, 2008
    Date of Event
    February 24, 2008
    Report Date
    February 26, 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
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROD WAS NOT RETURNED FOR ANALYSIS; THE DEVICE REMAINS IMPLANTED. RESULTS FROM THE PROD HISTORY RECORD REVIEW INDICATED THE PROD MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. THIS EVENT MEETS TASS CRITERIA. ADD'L INFO WAS REQUESTED 02/26/2008, 03/04/2008, 03/10/2008 AND 03/13/2008. ADD'L INFO WAS RECEIVED 03/03/2008 AND 03/14/2008. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED.

    Description of Event or Problem · 1

    A SURGEON REPORTS THAT DURING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, A FOREIGN BODY APPEARED TO BE STUCK TO THE HAPTIC. THE SURGEON WAS ABLE TO REMOVE A PIECE OF THE FOREIGN MATERIAL, BUT DISCARDED IT. THREE DAYS FOLLOWING THE SURGERY, THE PT RETURNED WITH ENDOPHTHALMITIS. CULTURES WERE NEGATIVE. THE SURGEON FEELS THIS IS NOT A LENS RELATED ISSUE. ADD'L INFO, INCLUDING PT STATUS, HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD / HUNTINGTON SN60WS 166609

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention