BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 3870104 · Received April 29, 2014

    Report

    Report Number
    2028159-2014-00762
    Event Type
    Malfunction
    Date Received
    April 29, 2014
    Date of Event
    March 1, 2014
    Report Date
    March 31, 2014
    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
    MN, US
    Reporter Occupation
    NURSE

    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 ADD'L REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT DURING AIR/FLUID EXCHANGE, USING THE EXTRUSION LINE, THE SYSTEM KEPT SWITCHING TO VITRECTOMY MODE. THIS HAPPENED SEVERAL TIMES DURING THE CASE CAUSING THE SURGEON TO HAVE TO STOP AND SWITCH BACK TO EXTRUSION MODE. THERE WAS NO ADVISORY. THE CASE WAS PROLONGED DUE TO THE EVENT. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256920 CONSTELLATION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON - IRVINE TECHNOLOGY CENTER TABLETOP NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK