BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION SURGICAL PROCEDURE PACK

    MDR report key: 19762370 · Received July 17, 2024

    Report

    Report Number
    1644019-2024-01574
    Event Type
    Malfunction
    Date Received
    July 17, 2024
    Date of Event
    June 18, 2024
    Report Date
    October 23, 2024
    Manufacturer
    ALCON RESEARCH, LLC - HOUSTON
    Product Code
    LRO
    UDI-DI
    00380657524501
    PMA / PMN Number
    K880961
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION PROVIDED IN D.9., H.3., H.6. AND H.11. A REVIEW OF THE DEVICE HISTORY RECORD TRACEABLE TO THE REPORTED LOT NUMBER INDICATES THAT THE PRODUCT WAS PROCESSED AND RELEASED ACCORDING TO THE PRODUCT¿S ACCEPTANCE CRITERIA. THE RETURNED SAMPLE WAS VISUALLY INSPECTED AND NO OBVIOUS DEFECTS WERE FOUND. THE PROBE ENGINE AND INFUSION CANNULA NEEDLE WERE CUT OFF FROM THE MANIFOLD ON RETURNED CONDITION. THE SURFACE OF THE TUBING INDICATE THAT THE PROBE ENGINE AND INFUSION CANNULA NEEDLE WERE CUT OFF. THE PROBE AND INFUSION CANNULA FROM LAB STOCK WAS USED FOR TESTING. THE NON-INVASIVE FLOW SENSOR (NIFS) ON THE CASSETTE HOUSING WAS IN GOOD CONDITION. A CALIBRATED CONSOLE REPRESENTING THE CURRENT SOFTWARE VERSION WAS USED TO TEST THE SAMPLE. THE BALL IN THE DRIP CHAMBER¿S CHECK VALVE MOVED FREELY PER SPECIFICATION. THE SAMPLE COULD PRIME AND PASS INTRAOCULAR LENS IMPLANTATION CALIBRATION SUCCESSFULLY. NO ANOMALIES WERE OBSERVED DURING PRIMING. NO SYSTEM MESSAGE CODE WAS GENERATED DURING TESTING. FLUID FLOWED FROM THE BALANCED SALT SOLUTION BOTTLE TO THE DRAIN BAG WITHOUT ANY INTERFERING. NO LEAKAGE WAS DETECTED FROM THE PUMP ELASTOMER OR ON THE PUMP AREA OF THE FLUIDICS MODULE. THE INFUSION, IRRIGATION, AND ASPIRATION PRESSURE WERE MEASURED AT MULTIPLE SET POINTS AND MET SPECIFICATIONS. TOGGLING THE INFUSION AND THE FLUID/AIR EXCHANGE (F/AX) MODES, FLUID AND AIR FLOWED FROM THE CASSETTE TO THE INFUSION LINE CONTINUOUSLY WITHOUT ANY BUBBLE IN VARIOUS SETTINGS IN ALL SUB MODES. CLEANING PROCESS WAS ABLE TO BE PERFORMED AFTER FUNCTIONAL TEST HAD COMPLETED. THE ROOT CAUSE OF THE CUSTOMER'S COMPLAINT COULD NOT BE ESTABLISHED; THE RETURNED SAMPLE FUNCTIONED PER SPECIFICATIONS. AFTER AN INVESTIGATION OF THIS COMPLAINT, IT HAS BEEN DETERMINED THAT THIS SAMPLE FUNCTIONED PER SPECIFICATIONS; THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. NO ADVERSE TRENDS HAVE BEEN OBSERVED ASSOCIATED WITH THE REPORTED PRODUCT AND EVENT. QUALITY ASSURANCE HAS REVIEWED THIS COMPLAINT AND WILL CONTINUE TO MONITOR DATA FOR EVIDENCE OF ADVERSE TRENDING AND TAKE FURTHER ACTION, AS APPROPRIATE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A PHYSICIAN REPORTED THAT ASPIRATION FAILURE OCCURRED DURING VITRECTOMY AND CATARACT COMBINATION SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE CASSETTE WITH ANOTHER ONE. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2150637 CONSTELLATION SURGICAL PROCEDURE PACK GENERAL SURGERY TRAY (KIT) LRO ALCON RESEARCH, LLC - HOUSTON NA 167DEM 00380657524501

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown CONSTELLATION VISION SYSTEM