BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERIES 20000 LEGACY

    MDR report key: 1202833 · Received October 17, 2008

    Report

    Report Number
    2028159-2008-00377
    Event Type
    Injury
    Date Received
    October 17, 2008
    Report Date
    September 17, 2008
    Manufacturer
    ALCON-IRVINE TECHNOLOGY CENTER
    Product Code
    HQE
    PMA / PMN Number
    K911808
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY SALES REP WENT TO THE FACILITY TO REVIEW THE CLEANING AND STERILIZATION PROCEDURES WITH THE STAFF. THE FACILITY STAFF IS FOLLOWING RECOMMENDED CLEANING AND STERILIZATION PRACTICES. THE ROOT CAUSE OF THE PT EVENT CANNOT BE DETERMINED IN THIS INVESTIGATION. (FOR USE WHEN THE DEVICE PROBLEM IS NOT KNOWN) THIS REPORT WAS MAILED TO FDA ON: 10/17/2008.

    Description of Event or Problem · 1

    THE NURSE HAD INITIALLY REPORTED SEVERAL CASES OF ENDOPHTHALMITIS. ADD'L INFO RECEIVED STATED THAT THERE WERE THREE CASES REPORTED WITH PT IDENTIFIERS. ONE PT WAS OPERATED ON WITH THIS SYSTEM, BEFORE THE SYSTEM WAS REPLACED WITH ANOTHER. THIS PT REPORTEDLY RECOVERED, WITH A PERSISTENT CONDITION AND LOSS OF SIGHT. ADD'L INFO HAS BEEN REQUESTED, BUT NOT RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERIES 20000 LEGACY PHACOFRAGMENTATION SYSTEM HQE ALCON-IRVINE TECHNOLOGY CENTER STTL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other