BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 2925362 · Received January 17, 2013

    Report

    Report Number
    2028159-2013-00071
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Date of Event
    December 14, 2012
    Report Date
    December 18, 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
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT THE CASSETTE DRAIN BAG FILLED WITH AIR DURING SURGERY. THE COMPANY REP EXAMINED THE SYSTEM AND NO PROBLEMS WERE FOUND. THE SYSTEM WAS THE TEST AND MET ALL PRODUCT SPECIFICATIONS. THE COMPANY REP OBSERVED THAT THE SYSTEM WAS USED IMPROPERLY BY THE CUSTOMER. THE ROOT CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO CUSTOMER MISUSE. (B)(4).

    Description of Event or Problem · 1

    AN ADMINISTRATOR REPORTED THAT THE CASSETTE'S BAG FILLED WITH AIR DURING VITRECTOMY SURGERY. WHEN THE CASSETTE BAG STARTED TO INFLATE, THE SYSTEM WAS EXCHANGED AND SURGERY WAS COMPLETED W/O IMPACT ON THE PT FOLLOWING A TEN MIN DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25420 CONSTELLATION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON - IRVINE TECHNOLOGY CENTER TABLETOP NA

    Patients

    Seq Age Sex Outcome Treatment
    1