BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 2913595 · Received December 21, 2012

    Report

    Report Number
    2028159-2012-02027
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Report Date
    November 28, 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
    FR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S COMPLAINT HISTORY WAS REVIEWED FOR THE PERIOD OF ONE YEAR; THIS IS 1 OF 2 COMPLAINTS REPORTED FOR THIS ISSUE. AS THE CUSTOMER DID NOT RETAIN THE FINISHED GOODS LOT NUMBER, DEVICE HISTORY RECORD (DHR) AND LOT HISTORY COULD NOT BE REVIEWED. THE CUSTOMER DID NOT RETAIN A SAMPLE FOR THIS COMPLAINT REPORT; FUNCTIONAL TESTING COULD NOT BE CONDUCTED. THE REPORT OF FLUID/AIR EXCHANGE ISSUES AND BUBBLES IN THE EYE COULD NOT BE REPLICATED. THE ROOT CAUSE OF THE CUSTOMER'S COMPLAINT IS NOT KNOWN; A SAMPLE WAS NOT RETURNED FOR THIS EVENT. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED BUBBLES IN THE PATIENT'S EYE DURING SURGERY. THE SURGEON NOTED THAT THE AUTO VALVE DID NOT WORK. AFTER MULTIPLE ATTEMPTS TO PERFORM THE FLUID/AIR SWITCH, THE SURGEON WAS ABLE TO PERFORM THE FLUID/AIR SWITCH WITH THE PRESSURE AT 80 MILLIMETERS OF MERCURY (MMHG). THE PROCEDURE WAS COMPLETED WITH NO HARM TO THE PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 25+ GAUGE TOTAL PLUS PAK 5.0 CPM