BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION SURGICAL PROCEDURE PACK

    MDR report key: 23579356 · Received November 18, 2025

    Report

    Report Number
    1644019-2025-04787
    Event Type
    Malfunction
    Date Received
    November 18, 2025
    Date of Event
    October 15, 2025
    Report Date
    February 25, 2026
    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
    PL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION PROVIDED IN D.9., H.3., H.6., AND H.11. THE RETURNED PRODUCT WAS VISUALLY INSPECTED AND THE NEEDLE TIP ON THE PROBE ENGINE WAS BROKEN OFF ON RETURNED CONDITION. THE BROKEN PIECE WAS RETURNED. 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 PRODUCT. THE BALL IN THE DRIP CHAMBER¿S CHECK VALVE MOVED FREELY PER SPECIFICATION. THE LIGHT EMITTING DIODE (LED) RINGS ON THE CONSOLE TURNED GREEN AS THE PROBE CONNECTORS WERE ENGAGED TO THE CONSOLE INDICATING THE PROPER COMMUNICATION BETWEEN THE PROBE AND THE CONSOLE. THE PRODUCT 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 BALANCED 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. 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 INVESTIGATION CONDUCTED A NON-CONFORMANCE REVIEW OF THE REPORTED LOT NUMBER. NO DEVIATIONS THAT COULD HAVE CONTRIBUTED TO THIS EVENT WERE IDENTIFIED AND ALL CORRESPONDING PRODUCTION RELEASE SPECIFICATIONS DEFINED IN THE DEVICE MASTER RECORD WERE MET. BASED ON THE EVALUATION OF THE INFORMATION AND MATERIALS RECEIVED, THE INVESTIGATION WAS UNABLE TO IDENTIFY THE ROOT CAUSE OR ORIGIN OF THE REPORTED EVENT. ADDITIONALLY, NO MANUFACTURING-RELATED DEFICIENCIES WERE FOUND THAT POTENTIALLY COULD HAVE CONTRIBUTED TO THE COMPLAINT. THE DAMAGE TO THE PROBE NEEDLE MOST LIKELY OCCURRED DURING THE RETURN PROCESS OF THE PRODUCT TO THE VERIFICATION SITE. NO FURTHER INVESTIGATIVE OR MANUFACTURING ACTIONS ARE WARRANTED AT THIS TIME DUE TO THE PRODUCT MEETING SPECIFICATIONS. RECEIPT OF ADDITIONAL RELEVANT INFORMATION OR SUPPORTING MATERIALS WILL PROMPT A RE-EVALUATION OF THE COMPLAINT INVESTIGATION. COMPLAINT DATA FOR ALL COMPANY PRODUCTS IS REVIEWED MONTHLY TO MONITOR FOR ADVERSE TRENDS. DURING THE LAST REVIEW, NO ADVERSE TRENDS WERE OBSERVED FOR THE REPORTED PRODUCT AND EVENT COMBINATION. QUALITY ASSURANCE HAS REVIEWED THIS COMPLAINT AND WILL CONTINUE TO MONITOR DATA FOR EVIDENCE OF ADVERSE TRENDING AND TAKE FURTHER ACTION, AS APPROPRIATE. NO FURTHER ACTION WARRANTED AT THIS TIME. 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

    CORRECTED INFORMATION PROVIDED IN D.4, H.4. 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

    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.

    Description of Event or Problem · 0

    A HEALTHCARE PROFESSIONAL REPORTED THAT THE CASSETTE FAILED TO MAINTAIN PRESSURE AND ANY ATTEMPT TO PRESS THE FOOTSWITCH RESULTED IN THE NEGATIVE PRESSURE BEING DEACTIVATED WITH AN ERROR CODE BEING DISPLAYED DURING VITRECTOMY SURGERY. THE PROCEDURE WAS COMPLETED. IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WAS PATIENT CONTACT WITH NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2325885 CONSTELLATION SURGICAL PROCEDURE PACK GENERAL SURGERY TRAY (KIT) LRO ALCON RESEARCH, LLC - HOUSTON NA 1707NC 00380650000965

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female CONSTELLATION VISION SYSTEM.| CUSTOM-PAK SURGICAL PROCEDURE PACK.