BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 3001721 · Received March 11, 2013

    Report

    Report Number
    2028159-2013-00411
    Event Type
    Malfunction
    Date Received
    March 11, 2013
    Date of Event
    February 18, 2013
    Report Date
    February 19, 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 TWO COMPLAINTS REPORTED FOR THIS ISSUE. THIS IS THE FIRST COMPLAINT REPORTED AGAINST THE FINISH GOODS LOT AND THE DHR (DEVICE HISTORY RECORD) SHOWS THE PRODUCT WAS RELEASED PER SPECS. THE CUSTOMER DID NOT RETAIN A SAMPLE FOR THIS COMPLAINT REPORT; FUNCTIONAL TESTING COULD NOT BE CONDUCTED. THE ROOT CAUSE IS UNK. A SAMPLE WAS NOT RETURNED FOR THIS COMPLAINT. WITHOUT A SAMPLE, IT IS NOT POSSIBLE TO ISOLATE THE ROOT CAUSE. AN INTERNAL INVESTIGATION HAS BEEN OPENED TO ADDRESS THIS ISSUE. (B)(4).

    Description of Event or Problem · 1

    AN OPHTHALMIC SURGEON REPORTED THAT AIR CAME OUT OF THE IRRIGATION LINE DURING A PROCEDURE, APPROX TEN MINUTES AFTER STARTING TO CUT THE VITREOUS BODY. THE PROBLEM WAS SOLVED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THE PROCEDURE WAS COMPLETED WITH NO HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101227 CONSTELLATION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON - IRVINE TECHNOLOGY CENTER LXT-JAPAN NA

    Patients

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