BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERIES TWENTY THOUSAND LAGACY

    MDR report key: 286093 · Received July 13, 2000

    Report

    Report Number
    2028159-2000-00170
    Event Type
    Malfunction
    Date Received
    July 13, 2000
    Date of Event
    June 14, 2000
    Report Date
    June 14, 2000
    Manufacturer
    ALCON-IRVINE TECHNOLOGY CENTER
    Product Code
    HQE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER NOTED UNIT STOPPED DURING "I/A". REBOOTED, CHANGED CASSETTE, CHANGED HANDPIECE AND IT STILL WOULDN'T OPERATE. COMPLETED "I/A" MANUALLY AND CANCELLED SUBSEQUENT CASES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERIES TWENTY THOUSAND LAGACY OPHTHALMIC SURGERY SYSTEM HQE ALCON-IRVINE TECHNOLOGY CENTER STTL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR