BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION SURGICAL PROCEDURE PACK

    MDR report key: 19687661 · Received July 8, 2024

    Report

    Report Number
    1644019-2024-01478
    Event Type
    Malfunction
    Date Received
    July 8, 2024
    Date of Event
    June 5, 2024
    Report Date
    November 13, 2024
    Manufacturer
    ALCON RESEARCH, LLC - HOUSTON
    Product Code
    LRO
    UDI-DI
    00380650000965
    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

    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 CONFIRMED THE PROBE ENGINE WAS CUT OFF FROM THE MANIFOLD ON RETURNED CONDITION. 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. PROBE FROM LAB STOCK WAS USED TO TEST THE RETURNED COMBINED PAK. THE SAMPLE COULD PRIME AND PASS INTRAOCULAR PRESSURE (IOP) CALIBRATION SUCCESSFULLY. NO ANOMALIES WERE OBSERVED DURING PRIMING. NO SYSTEM MESSAGE CODE WAS GENERATED DURING TESTING. FLUID FLOWED FROM THE BALANCE SALT SOLUTION (BSS) 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. 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). H10 REFLECTS ALL RELATED REPORT NUMBERS ASSOCIATED WITH THIS PRODUCT EVENT THAT HAVE BEEN SUBMITTED AT THIS TIME.

    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). H.10 REFLECTS ALL RELATED REPORT NUMBERS ASSOCIATED WITH THIS PRODUCT EVENT THAT HAVE BEEN SUBMITTED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4). H.10 REFLECTS ALL RELATED REPORT NUMBERS ASSOCIATED WITH THIS PRODUCT EVENT THAT HAVE BEEN SUBMITTED AT THIS TIME.

    Description of Event or Problem · 0

    THE PHYSICIAN REPORTED THAT ASPIRATION WAS WEAK IN THE CUTTER PROBE AND WAS NOT APPLIED DURING IRRIGATION ASPIRATION OR ULTRASOUND MODE BEFORE THE SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THE PROCEDURE TYPE WAS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    903674 CONSTELLATION SURGICAL PROCEDURE PACK GENERAL SURGERY TRAY (KIT) LRO ALCON RESEARCH, LLC - HOUSTON NA 1697AX 00380650000965

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown CONSTELLATION VISION SYSTEM