BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 2803003 · Received October 19, 2012

    Report

    Report Number
    2028159-2012-01612
    Event Type
    Malfunction
    Date Received
    October 19, 2012
    Date of Event
    September 21, 2012
    Report Date
    September 21, 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
    AR
    Reporter Occupation
    OTHER

    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 DOCTOR REPORTED THAT A SECTION OF THE HOSE INFLATED LIKE A BALLOON AND EXPLODED, PRODUCING A LOUD NOISE DURING THE VITRECTOMY PROCEDURE. AFTER A DELAY OF LESS THAN 15 MINUTES, THE CASE WAS COMPLETED WITHOUT FURTHER PROBLEMS USING ANOTHER SYSTEM. THERE WAS NO HARM TO THE PT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 HIGH PRESSURE GAS SUPPLY HOSE