BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 3994061 · Received July 24, 2014

    Report

    Report Number
    2028159-2014-01364
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Date of Event
    June 25, 2014
    Report Date
    June 25, 2014
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CTR
    Product Code
    HQC
    PMA / PMN Number
    K101285
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS IN PROGRESS. A SAMPLE HAS BEEN RECEIVED AND IT AWAITING EVAL. THE DEVICE HISTORY RECORDS (DHR) FOR THE LOTS WERE REVIEWED. NO ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE CUSTOMER COMPLAINT ISSUE WERE FOUND DURING THE DHR REVIEW AND THE PRODUCT WAS RELEASED ACCORDING TO THE MFR'S ACCEPTANCE CRITERIA. A ROOT CAUSE HAS NOT YET BEEN IDENTIFIED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT DURING A VITRECTOMY PROCEDURE, MICRO AIR BUBBLES WERE COMING FROM THE VITRECTOMY PROBE PORT WHILE THE CUTTER WAS WORKING. THE PROCEDURE WAS ABLE TO BE COMPLETED WITHOUT EXCHANGING THE PRODUCT. THERE WAS NO HARM TO THE PT. THIS IS THE FIRST OF TWO REPORTS FOR THIS FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435253 CONSTELLATION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON - IRVINE TECHNOLOGY CTR LXT NA

    Patients

    Seq Age Sex Outcome Treatment
    1 VITRECTOMY TOTAL PLUS PACK 20G 5000 CPM