BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION

    MDR report key: 1940112 · Received December 22, 2010

    Report

    Report Number
    2028159-2010-02435
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Report Date
    December 1, 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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY SERVICE REP EXAMINED THE SYSTEM AND REPLACED THE CORE MODULE. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. A SAMPLE IS EXPECTED TO RETURN FOR IN-HOUSE EVAL. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS 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 A SYSTEM MESSAGE DISPLAYED AND THE LASER FUNCTION WAS UNAVAILABLE. THE SYSTEM WAS EXCHANGED. IT IS UNK IF THE ISSUE OCCURRED DURING SET UP OR DURING A PROCEDURE. PT IMPACT UNK. ADD'L INFO HAS BEEN REQUESTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1