BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 2850089 · Received October 23, 2012

    Report

    Report Number
    2028159-2012-01423
    Event Type
    Malfunction
    Date Received
    October 23, 2012
    Date of Event
    August 9, 2012
    Report Date
    August 24, 2012
    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
    OH, 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 ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT THE FRAGMATOME HANDPIECE WOULD NOT PRIME DURING SURGERY; THE SCREEN INDICATED IT COULD NOT PRIME WHILE RUNNING. THE CARTRIDGE (CASSETTE) WAS CHANGED OUT AND THE MACHINE WAS SHUT DOWN, BUT IT WAS ALL UNSUCCESSFUL. THE OPERATING ROOM STAFF CALLED THE SALES REPRESENTATIVE AND HE STATED IT WAS POSSIBLE TO PRIME THE MACHINE DURING THE CASE. WHAT HE ADVISED HAD ALREADY BEEN PERFORMED BY THE CUSTOMER WITHOUT SUCCESS. IT IS UNKNOWN IF THERE WAS ANY PATIENT IMPACT. A MEDWATCH REPORT WAS RECEIVED, BUT DID NOT PROVIDE ANY ADDITIONAL INFORMATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 CONSTELLATION FRAGMENTATION HANDPIECE