BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION

    MDR report key: 1891091 · Received October 22, 2010

    Report

    Report Number
    2028159-2010-02046
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Report Date
    September 24, 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
    PE
    Reporter Occupation
    OTHER

    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 ADDITIONAL REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED: PHACO PACK HAD AN OBSTRUCTION IN THE MIDDLE OF A PHACO SURGERY. THE EVENT OCCURRED DURING (TWO CASES) DURING THE SAME OPERATING ROOM SESSION. THE SYSTEM WAS SWITCHED-OUT AND THE PROCEDURES WERE COMPLETED. THE CUSTOMER REPORTED, THE PTS WERE NOT AFFECTED AT ALL. ADD'L INFO WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSTELLATION UNIT, PHACOFRAGMENTATION HQC ALCON - IRVINE TECHNOLOGY CENTER CONSTELLATION 968331H

    Patients

    Seq Age Sex Outcome Treatment
    1 CONSTELLATION SURGICAL PAK