BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION WITH LASER

    MDR report key: 1761162 · Received July 15, 2010

    Report

    Report Number
    2028159-2010-01181
    Event Type
    Malfunction
    Date Received
    July 15, 2010
    Report Date
    June 15, 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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPANY SERVICE REPRESENTATIVE EXAMINED THE SYSTEM AND WAS UNABLE TO DUPLICATE THE REPORTED PROBLEMS. HOWEVER, THE EVENT WAS CONFIRMED IN THE ERROR LOG. THE LAMP AND THE ETHERNET CABLES WERE REPLACED AND SENT IN FOR IN-HOUSE EVALUATION. 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 INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "NO PATIENT IMPACT" (NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT). PRODUCT PROBLEM(S): "SYSTEM MESSAGES DISPLAYED" (DEVICE DISPLAYS ERROR MESSAGE). A CUSTOMER REPORTED RECEIVING SYSTEM MESSAGES DURING A CASE. ADDITIONAL INFORMATION WAS REQUESTED. ADDITIONAL INFORMATION WAS RECEIVED. THE NURSE MANAGER REPORTED THE SYSTEM MESSAGES WERE RECEIVED DURING A CASE. THE CUSTOMER REPORTED THE SYSTEM MESSAGES WERE CLEARED AND THE CASES WERE CONTINUED WITHOUT ANY PATIENT IMPACT.

    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