BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION WITH LASER

    MDR report key: 1891086 · Received October 22, 2010

    Report

    Report Number
    2028159-2010-02053
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Date of Event
    September 22, 2010
    Report Date
    September 23, 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
    IT
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    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

    DURING THE SURGERY, THE INFUSION VALVE (THE ONE THAT SUPPORTS THE FLUID/AIR EXCHANGE) DID NOT WORK: THE AIR DID NOT PASS THROUGH THE LINE. NO PT IMPACT WAS REPORTED. THE SALES PROMOTER CUT THE INFUSION LINE AND INSERTED A THREE-WAY VALVE TO BYPASS THE INFUSION VALVE. ADD'L INFO WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSTELLATION WITH LASER UNIT, PHACOFRAGMENTATION HQC ALCON - IRVINE TECHNOLOGY CENTER CONSTELLATION 1027851H

    Patients

    Seq Age Sex Outcome Treatment
    1 NI CONSTELLATION SURGICAL PAK