BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION WITH LASER

    MDR report key: 1791281 · Received August 6, 2010

    Report

    Report Number
    2028159-2010-01426
    Event Type
    Malfunction
    Date Received
    August 6, 2010
    Report Date
    July 9, 2010
    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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY DID NOT REQUEST SERVICE. NO SAMPLES WERE RETURNED FOR EVALUATION. THERE WAS NO SAMPLE RETURNED FOR EVALUATION AND NO ADDITIONAL INFO PROVIDED RELATED TO THIS EVENT. FOR THIS REASON, STEPS COULD NOT BE TAKEN TO REPLICATE OR CONFIRM THE REPORTED EVENT AND THE ROOT CAUSE IS THEREFORE, UNK AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): ¿NO PATIENT HARM/IMPACT (NO CONSEQUENCES OR IMPACT TO PATIENT). PRODUCT PROBLEM(S): ¿SYSTEM MESSAGE DISPLAYED¿ (DEVICE DISPLAYS ERROR MESSAGE). THE SURGEON REPORTED A SYSTEM MESSAGE DISPLAYED DURING SURGERY. THE SYSTEM WAS REBOOTED AND THE CASE WAS COMPLETED AS PLANNED. NO PATIENT INJURY 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 UNK