BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION WITH LASER

    MDR report key: 1832020 · Received September 3, 2010

    Report

    Report Number
    2028159-2010-01639
    Event Type
    Malfunction
    Date Received
    September 3, 2010
    Date of Event
    June 23, 2010
    Report Date
    August 5, 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
    HK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY SERVICE REPRESENTATIVE EXAMINED THE SYSTEM AND CONFIRMED THE PROBLEM REPORTED. THE FLUIDICS MODULE WAS REPLACED. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY WHEN ADD'L REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "NO PT INJURY REPORTED" (NO CONSEQUENCES OR IMPACT TO PT). PRODUCT PROBLEM(S): "SYSTEM WOULD NOT PRIME" (FAILURE TO PRIME); "SYSTEM MESSAGE DISPLAYED" (DEVICE ERROR MESSAGE). THE CUSTOMER REPORTED A SYSTEM MESSAGE DISPLAYED AND THE SYSTEM WOULD NOT PRIME. THE SYSTEM WAS SWITCHED OUT TO PROCEED WITH THE SURGERY. NO PT 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