BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION SURGICAL PROCEDURE PACK

    MDR report key: 23219032 · Received October 5, 2025

    Report

    Report Number
    1644019-2025-03793
    Event Type
    Malfunction
    Date Received
    October 5, 2025
    Date of Event
    September 9, 2025
    Report Date
    December 30, 2025
    Manufacturer
    ALCON RESEARCH, LLC - HOUSTON
    Product Code
    LRO
    PMA / PMN Number
    K880961
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION PROVIDED IN H.6. AND H.11. A SAMPLE WAS NOT RECEIVED AT THE INVESTIGATION 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 NONCONFORMANCE REVIEW OF THE REPORTED LOT NUMBERS. FOUR NON-CONFORMANCES WERE IDENTIFIED RELATED TO THE PROBE ENGINE DRIVELINE HOLE, CUT FAILURE, EXCESSIVE ADHESIVE AT DIAPHRAGM AND DAMAGED O RING ON PROBE; THESE RELATED NON-CONFORMANCES COULD HAVE POTENTIALLY CONTRIBUTED TO THE REPORTED EVENT. 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 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 PHYSICIAN REPORTED THAT PROBE HAD POOR CUTTING BUT ASPIRATION WAS NORMAL BEFORE VITRECTOMY SURGERY. THE SURGERY WAS SUCCESSFULLY COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1651873 CONSTELLATION SURGICAL PROCEDURE PACK GENERAL SURGERY TRAY (KIT) LRO ALCON RESEARCH, LLC - HOUSTON NA 179TY7

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown