BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 3112086 · Received May 7, 2013

    Report

    Report Number
    2028159-2013-00869
    Event Type
    Malfunction
    Date Received
    May 7, 2013
    Report Date
    April 12, 2013
    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 ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT THERE WAS AN INFUSION AND IRRIGATION PROBLEM DURING A CATARACT PROCEDURE THAT WOULD NOT ALLOW THEM TO CONTINUE WITH THE CASE. IT WAS REPORTED THAT A SYSTEM MESSAGE DISPLAYED AND "ALL FUNCTIONS WERE CANCELED ON THE DISPLAY". THE SYSTEM WAS EXCHANGED AND THE CASE WAS COMPLETED WITHOUT HARM TO THE PATIENT. AFTER COMPLETION OF THE SURGERY, THE PACK WAS REPLACED ON THE FIRST SYSTEM. THE SYSTEM WAS THEN USED TO COMPLETE THE REMAINING CASES FOR THE DAY WITH NO FURTHER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199986 CONSTELLATION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON - IRVINE TECHNOLOGY CENTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 COMBINED PAK, 25+ 5.0 CPM 0.9