BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION SURGICAL PROCEDURE PACK

    MDR report key: 23590690 · Received November 19, 2025

    Report

    Report Number
    1644019-2025-04827
    Event Type
    Malfunction
    Date Received
    November 19, 2025
    Date of Event
    October 23, 2025
    Report Date
    April 7, 2026
    Manufacturer
    ALCON RESEARCH, LLC - HOUSTON
    Product Code
    LRO
    UDI-DI
    00380657531066
    PMA / PMN Number
    K880961
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION PROVIDED IN H.6. AND H.11. A SAMPLE WAS NOT RECEIVED AT THE MANUFACTURING SITE FOR EVALUATION; THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED. A REVIEW OF THE DEVICE HISTORY RECORD TRACEABLE TO THE REPORTED LOT NUMBER, INDICATES THAT THE REPORTED PRODUCT WAS PROCESSED AND RELEASED ACCORDING TO THE REPORTED PRODUCT¿S ACCEPTANCE CRITERIA. THE INVESTIGATION CONDUCTED A NON-CONFORMANCE REVIEW OF THE REPORTED LOT NUMBER. NO DEVIATIONS WERE IDENTIFIED AND ALL CORRESPONDING PRODUCTION RELEASE SPECIFICATIONS DEFINED. 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. AS THE ROOT CAUSE AND ITS ORIGIN ARE INCONCLUSIVE, FURTHER INVESTIGATIVE OR MANUFACTURING ACTIONS ARE NOT WARRANTED AT THIS TIME. A NONCONFORMANCE INVESTIGATION HAS BEEN COMPLETED IN RELATION TO THE TREND IDENTIFIED FOR PROBES WITH WOULD NOT CUT OR ACTUATE ISSUES. ALL PROBES ARE 100% VISUALLY INSPECTED AND TESTED FOR ACTUATION, ASPIRATION, AND CUT DURING MANUFACTURING. 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, 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).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION PROVIDED IN D.9., H.3., H.6. AND H.11. ONE OPENED PROBE WAS RECEIVED, WITH A TIP PROTECTOR, IN A TRAY, FOR THE REPORT. THE SAMPLE WAS VISUALLY INSPECTED AND FOUND TO BE NONCONFORMING WITH ORANGE/BROWN FOREIGN MATERIAL ON THE PORT FACE, INSIDE THE PORT AND ON THE WELDED CAP. NEEDLE WAS BENT AT THE STIFFENER. THE SAMPLE WAS THEN FUNCTIONALLY TESTED FOR ACTUATION, ASPIRATION AND CUT. THE SAMPLE WAS FOUND TO BE CONFORMING FOR ASPIRATION AND NONCONFORMING FOR ACTUATION AND CUT. THE PROBE WAS DISASSEMBLED AND THE COMPONENTS INSPECTED. NOMINAL WEAR OBSERVED ON INNER CUTTER WHEN COMPARED TO THE DEGREE OF WEAR BASED ON CONTINUOUS ACTUATION OF THE PROBE VISUAL STANDARD PHOTOS. GOUGE AND WEAR MARKS OBSERVED AT SEVERAL LOCATIONS ON THE INNER CUTTER. INNER CUTTER WAS OBSERVED TO BE BENT. A REVIEW OF THE DEVICE HISTORY RECORD TRACEABLE TO THE LOT NUMBER OBTAINED FROM THE DEVICE¿S RADIO FREQUENCY IDENTIFICATION (RFID) TAG, INDICATES THAT THE REPORTED PRODUCT WAS PROCESSED AND RELEASED ACCORDING TO THE REPORTED PRODUCT¿S ACCEPTANCE CRITERIA. THE INVESTIGATION CONDUCTED A NON-CONFORMANCE REVIEW OF THE REPORTED LOT NUMBER. NO DEVIATIONS 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 COMPLAINT EVALUATION CONFIRMS THE PROBE HAD A CUT FAILURE AND DOES NOT CONFIRM AN ASPIRATION FAILURE. THE MOST LIKELY CAUSE FOR THE CUT FAILURE IS FROM THE BENT NEEDLE AND BENT INNER CUTTER. A BENT NEEDLE CAN IMPEDE THE MOVEMENT OF THE CUTTER SHAFT. THIS INTERFERENCE IS PRESENT AS OBSERVED FROM VISUAL CONDITION OF THE INNER CUTTER. THE EXACT ROOT CAUSE OF THE BENT NEEDLE AND BENT INNER CUTTER CANNOT BE DETERMINED FROM THIS EVALUATION. THE MOST LIKELY ROOT CAUSE IS HANDLING AT ANY POINT AFTER THE PROBE WAS SHIPPED FROM THE MANUFACTURING SITE. AS THE ROOT CAUSE AND ITS ORIGIN ARE INCONCLUSIVE, FURTHER INVESTIGATIVE OR MANUFACTURING ACTIONS ARE NOT WARRANTED AT THIS TIME AS PROBE WAS CONFORMING FOR ASPIRATION AND THE EXACT ROOT CAUSE OF THE CUT FAILURE AND BENT NEEDLE AND BENT INNER CUTTER COULD NOT BE DETERMINED. A NONCONFORMANCE INVESTIGATION WAS COMPLETED TO INVESTIGATE THE TREND IDENTIFIED FOR PROBES WITH WOULD NOT CUT OR ACTUATE ISSUES. ALL PROBES ARE 100% VISUALLY INSPECTED AND TESTED FOR ACTUATION, ASPIRATION, AND CUT DURING MANUFACTURING. ANY NON-CONFORMANCES FOUND ARE REMOVED FROM THE LOT AND SCRAPPED. 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, 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).

    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 NURSE REPORTED THAT VITRECTOMY PROBE WAS UNABLE TO CUT AND ASPIRATE THE VITREOUS BODY NORMALLY DURING THE VITRECTOMY SURGERY. A NEW ONE WAS REPLACED FOR THE SURGERY, DELAYING THE ENTIRE SURGERY FOR TEN MINUTES WITHOUT ANY ABNORMALITIES. THERE WAS NO IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218523 CONSTELLATION SURGICAL PROCEDURE PACK GENERAL SURGERY TRAY (KIT) LRO ALCON RESEARCH, LLC - HOUSTON NA 17ET0T 00380657531066

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown