BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 2985190 · Received February 26, 2013

    Report

    Report Number
    2028159-2013-00297
    Event Type
    Injury
    Date Received
    February 26, 2013
    Date of Event
    January 24, 2013
    Report Date
    January 30, 2013
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K101285
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CALLED THE COMPANY REPRESENTATIVE TO ASSIST WITH TROUBLESHOOTING. THE COMPANY REPRESENTATIVE REVIEWED THAT IT MAY BE A CASSETTE ISSUE. THE CUSTOMER COMPLETED MULTIPLE CASES WITH NO FURTHER PROBLEMS NOTED. THE CUSTOMER DID NOT REQUEST SERVICE. THERE WAS NO SAMPLE RETURNED FOR EVALUATION AND NO ADDITIONAL INFORMATION PROVIDED RELATED TO THIS EVENT. FOR THIS REASON, STEPS COULD NOT BE TAKEN TO REPLICATE OR CONFIRM THE REPORTED EVENT. A COMPANY CLINICAL ANALYST REVIEWED THIS FILE AND STATED: THE CUSTOMER REPORTED THAT BEFORE SURGERY, IT WAS NOTED THAT THERE WAS NO INFUSION FLUID WHEN THE SYSTEM IS IN PROPORTIONAL VITRECTOMY MODE. THEN DURING SURGERY, WHILE PERFORMING SILICONE OIL REMOVAL, A SYSTEM MESSAGES DISPLAYED (PROPORTIONAL REFLUX MODE IS NOT AVAILABLE WHEN FOOTSWITCH TREADLE IS DEPRESSED) WHEN THE SURGEON PLACED THE VITRECTOR PROBE IN THE ANTERIOR CHAMBER (AC) AND PRESSED THE FOOTSWITCH FOR FLUID TO DEEPEN THE CHAMBER (ENGAGED REFLUX), NO FLUID CAME OUT AND THE ANTERIOR CHAMBER COLLAPSED. THE VITRECTOR WAS DESIGNED FOR USE TO CUT INTRAOCULAR TISSUE AND ASPIRATE THE MATERIAL AS IT IS DISSECTED AND DOES NOT HAVE AN INFUSION FUNCTION BY ITSELF. IN THIS INSTANCE WHEREIN THE SURGEON WANTED TO DEEPEN THE AC, BY PLACING THE VITRECTOR IN THE AC, THE USER MOST LIKELY ENGAGED THE REFLUX FUNCTION OF THE SYSTEM. THE REFLUX FUNCTION BASICALLY SPEWS OUT PREVIOUSLY ASPIRATED MATERIAL AND FLUID PRIMARILY DESIGNED TO DISENGAGE INTRAOCULAR TISSUE THAT HAS BEEN INADVERTENTLY (UNINTENTIONAL) ASPIRATED. THE INTENTION OF THE USER WAS TO USE THE REFLUX FLUID TO PROVIDE "INFUSION" TO THE AC. WHAT APPEARS TO HAVE HAPPENED IN THIS INSTANCE IS THE OPERATOR ENGAGED THE REFLUX FUNCTION WHILE STILL ENGAGED WITH THE TREADLE, WHICH TRIGGERED THE SYSTEM MESSAGE HENCE THE REFLUX "FLUID" WAS NOT AVAILABLE. THE REFLUX FUNCTIONALITY AND OPERATIVE FEATURES ARE DESCRIBED IN THE SYSTEM OPERATOR'S MANUAL. IT SHOULD ALSO BE NOTED THAT THE REFLUX FLUID IS LIMITED TO THE AMOUNT IN THE CASSETTE CHAMBER THAT IS FILLED UP BY THE ASPIRATION FLUID. WITHOUT ADDITIONAL DETAILS, EVENT LOGS TO REVIEW, IT IS DIFFICULT TO ASCERTAIN EXACT ROOT CAUSE IN THIS INSTANCE AS THE SYSTEM APPEARS TO HAVE PERFORMED AS INTENDED. A REVIEW OF THE SYSTEM'S EVENT LOG REVEALED THAT SM REPORTED (PROPORTIONAL REFLUX MODE IS NOT AVAILABLE WHEN THE FOOTSWITCH TREADLE IS DEPRESSED) DID NOT OCCUR. HOWEVER, SM (PROPORTIONAL REFLUX MODE IS CURRENTLY NOT AVAILABLE) OCCURRED ON (B)(6) 2013 AT 4:10:08 PM, WHICH IS RELATED TO THE REPORTED EVENT OF "REFLUX NOT AVAILABLE." A REVIEW OF COMPLAINTS FOR THE LAST 24 MONTHS DID NOT INDICATE ANY ADDITIONAL SIMILAR REPORTS FOR THIS SYSTEM. THE ROOT CAUSE CANNOT BE DETERMINED CONCLUSIVELY. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THERE WAS NO INFUSION OF FLUID WHEN THE MACHINE WAS ON PROPORTIONAL VITRECTOMY. THE SURGEON WAS REMOVING THE SILICONE OIL AND PLACED THE VITRECTOR PROBE IN THE ANTERIOR CHAMBER OF THE EYE. HE DEPRESSED THE FOOTSWITCH FOR FLUID TO DEEPEN THE CHAMBER OF THE EYE AND THERE WAS NO INFUSION AND A SYSTEM MESSAGE DISPLAYED. THE REPORTED EVENT RESULTED IN THE CASE TAKING LONGER THAN EXPECTED, AND THE PATIENT EXPERIENCED AN ANTERIOR CHAMBER COLLAPSE. THE SURGEON REPORTED THAT THE PATIENT ALSO HAS BLOOD IN THE ANTERIOR CHAMBER AND IN DESCEMET'S FOLD. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81063 CONSTELLATION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON - IRVINE TECHNOLOGY CENTER XT NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other