BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 2913539 · Received December 21, 2012

    Report

    Report Number
    2028159-2012-02040
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    November 26, 2012
    Report Date
    December 3, 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER¿S COMPLAINT HISTORY WAS REVIEWED FOR THE PERIOD OF ONE YEAR; THIS IS THE ONLY COMPLAINT REPORTED FOR THIS ISSUE. THIS IS THE ONLY COMPLAINT OF THIS NATURE REPORTED AGAINST THE FINISHED GOODS LOT AND THE DEVICE HISTORY REPORT (DHR) SHOWS THE PRODUCT WAS RELEASED PER SPECIFICATIONS. THE CUSTOMER DID NOT RETAIN A SAMPLE FOR THIS COMPLAINT REPORT; FUNCTIONAL TESTING COULD NOT BE CONDUCTED. THE CUSTOMER¿S REPORT OF POOR IRRIGATION AND ASPIRATION 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 THAT WHEN HE STEPPED ON THE FOOTSWITCH, THERE WAS POOR IRRIGATION AND ASPIRATION DURING SURGERY. THE FOOTSWITCH WAS EXCHANGED AND 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 VALVED| FOOTSWITCH