BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 2960462 · Received January 25, 2013

    Report

    Report Number
    2028159-2013-00097
    Event Type
    Malfunction
    Date Received
    January 25, 2013
    Date of Event
    December 28, 2012
    Report Date
    December 28, 2012
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K101285
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A SAMPLE HAS BEEN RECEIVED, BUT HAS NOT YET BEEN EVALUATED. 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

    AN OPHTHALMOLOGIST REPORTED THAT DURING A PROCEDURE, THE FLUID-AIR EXCHANGE TUBING WAS FAULTY; THE AIR TUBING WAS NOT WORKING. IT WAS NOTED THAT THE SCRUB NURSE TESTED THE TUBING UNDER WATER BUT THERE WERE NO BUBBLES OBSERVED. THE TUBING WAS EXCHANGED AND THE CASE WAS ABLE TO BE COMPLETED WITHOUT HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35533 CONSTELLATION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON - IRVINE TECHNOLOGY CENTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR CUSTOM PAK| PRIMARY PAK 23 GAUGE 5.0 CPM