BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION WITH LASER

    MDR report key: 2161677 · Received June 16, 2011

    Report

    Report Number
    2028159-2011-00672
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    April 28, 2011
    Report Date
    April 28, 2011
    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
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP EXAMINED THE SYSTEM AND WAS UNABLE TO DUPLICATE THE CUSTOMER REPORTED INTRAOCULAR PRESSURE (IOP) ISSUE; THE FLUIDICS MODULE WAS REPLACED FOR DIAGNOSTIC PURPOSE. THE COMPANY REP CONFIRMED THE TABLETOP ILLUMINATOR LAMP EXCEEDED 400 HRS AND REPLACED THE LAMP. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. THE FLUIDICS MODULE WAS RETURNED AND IN-HOUSE TESTING IS IN PROGRESS. 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 RECEIVING MULTIPLE SYSTEM MESSAGES DURING A PROCEDURE. THE CUSTOMER REPORTED AS THE SURGEON WAS USING IOP CONTROL, THE IOP COMPENSATION TURNED OFF AND A SYSTEM MESSAGE WAS DISPLAYED ADVISING TO CHECK FOR BUBBLES. THE SYSTEM WAS SWITCHED OUT AND THE CASE WAS COMPLETED WITH NO HARM OR INJURY TO THE PT.

    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