BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 3040416 · Received April 3, 2013

    Report

    Report Number
    2028159-2013-00592
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 7, 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 THE FIRST COMPLAINT REPORTED FOR THIS ISSUE. THIS IS ONE OF TWO COMPLAINTS REPORTED AGAINST THE FINISHED GOODS LOT AND THE DHR (DEVICE HISTORY RECORD) 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 NOT POSSIBLE TO ISOLATE THE ROOT CAUSE. AN INTERNAL INVESTIGATION HAS BEEN OPENED TO ADDRESS REPORTS OF A SIMILAR NATURE. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT AIR CAME INTO A PATIENT'S EYE DURING A PROCEDURE EVEN THOUGH AIR HAD NOT BEEN SELECTED; THIS INTERFERED WITH THE SURGEON'S VISIBILITY. THE PROBLEM WAS SOLVED AFTER THE PRODUCT WAS REPLACED. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136587 CONSTELLATION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON-IRVINE TECHNOLOGY CENTER T-JAPAN NA

    Patients

    Seq Age Sex Outcome Treatment
    1