BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALCON

    MDR report key: 447815 · Received March 10, 2003

    Report

    Report Number
    447815
    Event Type
    Other
    Date Received
    March 10, 2003
    Date of Event
    January 31, 2003
    Report Date
    February 17, 2003
    Manufacturer
    ALCON LABORATORIES
    Product Code
    HQE
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT WAS IN SURGERY FOR LEFT EYE PARS PLANA VITRECTOMY FOR REMOVAL OF RETAINED LENS FRAGMENTS. IT APPEARS THAT SEVERAL SPECIFIC PROBLEMS WERE ENCOUNTERED WITH THIS SYSTEM: 1) SYSTEM NOT "BOOTING UP", 2) SYSTEM NOT ACCEPTING THE CASSETTE. 3) NO ASPIRATIONS AND/OR IRRIGATION THRU/DURING FRAGATOME USE, AND 4) A FAILURE OF THE FRAGATOME TO OPERATE PROPERLY OR HAVE THE DESIRED EFFECT AS REPORTED BY THE SURGEON. BIOMEDICAL SERVICES DEPT HAS BEEN UNABLE TO DUPLICATE ANY OF THESE PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALCON ACCURUS OPHTHALMIC SURGICAL SYSTEM HQE ALCON LABORATORIES * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other