BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 3030462 · Received March 27, 2013

    Report

    Report Number
    2028159-2013-00541
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    February 25, 2013
    Report Date
    February 26, 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S COMPLAINT HISTORY WAS REVIEWED FOR THE PERIOD OF ONE YEAR; THIS IS ONE OF FIVE COMPLAINTS REPORTED FOR THIS ISSUE. THIS IS THE FIRST COMPLAINT REPORTED AGAINST THE FINISH GOODS LOT AND THE DEVICE HISTORY RECORD (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. WITHOUT A SAMPLE, IT IS POSSIBLE TO ISOLATE THE ROOT CAUSE. AN INTERNAL INVESTIGATION HAS BEEN OPENED TO ADDRESS THIS ISSUE. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT A LARGE AMOUNT OF AIR CAME INTO THE PATIENT'S EYE DURING A VITRECTOMY PROCEDURE. THE CUSTOMER STATED THAT THE VALVE FOR AIR SUBSTITUTION WAS OPENED AND THE LARGE AMOUNT OF AIR APPEARS TO HAVE COME FROM THERE. ALTHOUGH THE AIR IN THE PATIENT'S EYE CAUSED THE SURGEON'S VISIBILITY TO BE POOR, THE PROCEDURE WAS ABLE TO BE COMPLETED WITH NO IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125431 CONSTELLATION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON - IRVINE TECHNOLOGY CENTER LXT-JAPAN NA

    Patients

    Seq Age Sex Outcome Treatment
    1 CUSTOM PAK, 25 GAUGE VALVED