BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION WITH LASER

    MDR report key: 1760862 · Received July 14, 2010

    Report

    Report Number
    2028159-2010-01179
    Event Type
    Malfunction
    Date Received
    July 14, 2010
    Report Date
    June 14, 2010
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CTR
    Product Code
    HQC
    PMA / PMN Number
    K063583
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "PT STATUS UNK" (NO KNOWN IMPACT OR CONSEQUENCE TO PT). PRODUCT PROBLEM(S): "FROZEN TOUCHSCREEN" (NO DISPLAY OR DISPLAY FAILURE). A CUSTOMER REPORTS, THE TOUCHSCREEN WAS UNRESPONSIVE. THE FOOTSWITCH WAS USED TO NAVIGATE THROUGH SETTINGS. ADDITIONAL INFO WAS REQUESTED BUT NONE HAS BEEN RECEIVED TO DATE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1