BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 2961702 · Received February 11, 2013

    Report

    Report Number
    2028159-2013-00150
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    January 15, 2013
    Report Date
    January 15, 2013
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K101285
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CALLED THE COMPANY REP TO ASSIST WITH TROUBLESHOOTING. THE COMPANY REP ADVISED THE CUSTOMER TO RESTART THE SYSTEM. THE SYSTEM MESSAGE WAS RESOLVED BY RESTARTING THE SYSTEM. THE FACILITY DID NOT REQUEST SERVICE. THERE WAS NO SAMPLE RETURNED FOR EVAL AND NO ADDITIONAL INFORMATION PROVIDED RELATED TO THIS EVENT. FOR THIS REASON, STEPS COULD NOT BE TAKEN TO REPLICATE OR CONFIRM THE REPORTED EVENT. A REVIEW OF THE SYSTEM'S EVENT LOG FOR THE DATE OF THE REPORTED EVENT, (B)(6) 2013, WAS ABLE TO CONFIRM THE CUSTOMER REPORTED SYSTEM MESSAGE. A REVIEW OF COMPLAINTS FOR THE LAST (B)(4) DID NOT INDICATE ANY ADDITIONAL SIMILAR REPORTS FOR THIS SYSTEM. THE ROOT CAUSE OF THE CUSTOMER REPORTED EVENT WAS DETERMINED TO BE AN ISSUE WITH THE SOUND HANDLER. AN INTERNAL INVESTIGATION HAS BEEN OPENED TO ADDRESS THIS ISSUE. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT DURING A PROCEDURE, A SYSTEM MESSAGE DISPLAYED WHEN ATTEMPTING TO INFUSE SILICONE OIL. ALSO, THE FAN NOISE WAS NOTED AS UNUSUALLY LOUD. MANUAL INJECTION OF THE OIL WAS PERFORMED, AND THE CASE WAS COMPLETED WITHOUT HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59724 CONSTELLATION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON - IRVINE TECHNOLOGY CENTER LXT NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK