BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 3070673 · Received April 17, 2013

    Report

    Report Number
    2028159-2013-00699
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Date of Event
    March 18, 2013
    Report Date
    March 20, 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
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CALLED THE COMPANY TECHNICAL SUPPORT SPECIALIST (TSS) TO RECORD THE SYSTEM MESSAGE DISPLAYED (FLOW CHECK FAILURE). THE CUSTOMER WORKED WITH THE COMPANY SALES REPRESENTATIVE TO TROUBLESHOOT THE PROBLEM REPORTED. THE CUSTOMER DID NOT REQUEST SERVICE. THERE WAS NO SAMPLE RETURNED FOR EVALUATION 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 COMPLAINTS FOR THE LAST 24 MONTHS DID NOT INDICATE ANY ADDITIONAL SIMILAR REPORTS FOR THIS SYSTEM. THE ROOT CAUSE CANNOT BE DETERMINED CONCLUSIVELY. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT A SYSTEM MESSAGE DISPLAYED PRIOR TO A VITRECTOMY PROCEDURE. THEY CALLED TECHNICAL SUPPORT FOR ASSISTANCE, HOWEVER, THEY WERE UNABLE TO RESOLVE THE ISSUE. THE CASE WAS ABLE TO BE PERFORMED WITH ANOTHER SYSTEM FOLLOWING A DELAY OF ONE HOUR. THE PATIENT HAD RECEIVED PERIBULBAR ANESTHESIA AT THE TIME OF THE EVENT. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166292 CONSTELLATION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON - IRVINE TECHNOLOGY CENTER LXT NA

    Patients

    Seq Age Sex Outcome Treatment
    1