BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 3820676 · Received April 10, 2014

    Report

    Report Number
    2028159-2014-00570
    Event Type
    Malfunction
    Date Received
    April 10, 2014
    Date of Event
    March 7, 2014
    Report Date
    March 12, 2014
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K101285
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SAMPLE HAS BEEN RECEIVED, BUT HAS NOT YET BEEN EVALUATED. A SUPPLEMENTAL MDR WILL BE FIELD AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT THE VALVED TROCAR THEY USED DURING SURGERY WAS LEAKING. SURGERY WAS COMPLETED WITH A 10 MINUTES DELAY. THE PATIENT DID NOT EXPERIENCE ANY IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216662 CONSTELLATION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON - IRVINE TECHNOLOGY CENTER WITH LASER NA

    Patients

    Seq Age Sex Outcome Treatment
    1 CUSTOM PAK| 23 GA VALVED TROCAR