BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION WITH LASER

    MDR report key: 2030932 · Received March 4, 2011

    Report

    Report Number
    2028159-2011-00209
    Event Type
    Malfunction
    Date Received
    March 4, 2011
    Date of Event
    February 11, 2011
    Report Date
    February 11, 2011
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K063583
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    A SAMPLE WAS NOT RETURNED FOR EVALUATION. THE CUSTOMER'S COMPLAINT HISTORY WAS REVIEWED AND THIS IS THE FIRST EVENT REPORTED REGARDING THIS ISSUE FOR THIS FACILITY. THERE ARE NO ADDITIONAL REPORTS AGAINST THIS FINISHED GOODS LOT. THE PAK WAS BUILT PER SPECIFICATIONS. CUSTOMER DID NOT RETAIN A SAMPLE TO RETURN FOR INVESTIGATION; THEREFORE, IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THIS INCIDENT. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THERE WAS FLUID LEAKING FROM THE BOTTOM LEFT CORNER OF THE DRAIN BAG DURING A PROCEDURE. THE DRAIN BAG WAS EXCHANGED AND THE SURGERY WAS CONCLUDED. THERE WAS NO HARM OR INJURY TO THE PATIENT.

    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