BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 3853126 · Received April 2, 2014

    Report

    Report Number
    2028159-2014-00561
    Event Type
    Malfunction
    Date Received
    April 2, 2014
    Date of Event
    February 1, 2014
    Report Date
    March 7, 2014
    Manufacturer
    ALCON - IRVINE TECH CTR
    Product Code
    HQC
    PMA / PMN Number
    K101285
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROCESS. 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 CUSTOMER REPORTED SEVERAL CASES OF VITRECTOMY CUTTER NOT ACTIVATION DURING A PROCEDURE. THE SYSTEM WAS RE-BOOTED AND SURGERY WAS COMPLETED WITH NO HARM TO THE PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200007 CONSTELLATION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON - IRVINE TECH CTR LXT NA

    Patients

    Seq Age Sex Outcome Treatment
    1