BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 2972352 · Received February 15, 2013

    Report

    Report Number
    2028159-2013-00216
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 18, 2013
    Report Date
    January 18, 2013
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K101285
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REPRESENTATIVE EXAMINED THE SYSTEM AND DUPLICATED THE PROBLEM REPORTED. THE COMPANY REPRESENTATIVE FOUND THAT THE PNEUMATICS AIR TUBE (T1) WAS DISCONNECTED. THE COMPANY REPRESENTATIVE RECONNECTED THE TUBE AND THE ISSUE WAS RESOLVED. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. THERE WAS NO SAMPLE RETURNED FOR EVALUATION AND NO ADDITIONAL INFORMATION PROVIDED RELATED TO THIS EVENT. A REVIEW OF COMPLAINTS FOR THE LAST (B)(4) DID NOT INDICATE ANY ADDITIONAL SIMILAR REPORTS FOR THIS SYSTEM. THE ROOT CAUSE OF THE REPORTED EVENT WAS DETERMINED TO BE A DISCONNECTED PNEUMATICS AIR TUBE (T1). THE TUBE WAS RECONNECTED AND THE ISSUE WAS RESOLVED. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT A MESSAGE RELATED TO NITROGEN GAS PRESSURE ADJUSTMENT DISPLAYED DURING SURGERY. THE SYSTEM WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED WITH NO HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69796 CONSTELLATION VISION SYSTEM UNIT, FHACOFRAGMENTATION HQC ALCON - IRVINE TECHNOLOGY CENTER LXT-JAPAN NA

    Patients

    Seq Age Sex Outcome Treatment
    1 COMBINED PROCEDURE PAK