BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION WITH LASER

    MDR report key: 2180973 · Received July 7, 2011

    Report

    Report Number
    2028159-2011-00766
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Report Date
    June 7, 2011
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K063583
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP EXAMINED THE SYSTEM AND REPLACED THE FLUIDICS MODULE. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. A SAMPLE HAS BEEN REC'D, BUT THE EVAL HAS NOT BEEN COMPLETED. INVESTIGATION INCLUDING ROOT CAUSE IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADD'L REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT DURING AIR/FLUID EXCHANGE, THE INFUSION STOPPED AND A SYSTEM MESSAGE WAS DISPLAYED INDICATING THERE WAS AN IRRIGATION OUTPUT VALVE ERROR. THE EYE WAS STABILIZED WHILE THEY POWERED DOWN THE SYSTEM, INSERTED A DIFFERENT CASSETTE, AND REBOOTED. THERE WAS A DELAY OF APPROX 15 MINS WHILE REBOOTING. THE CASE WAS COMPLETED AND NO HARM TO THE PT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSTELLATION WITH LASER UNIT, PHACOFRAGMENTATION HQC ALCON - IRVINE TECHNOLOGY CENTER CONSTELLATION NA

    Patients

    Seq Age Sex Outcome Treatment
    1