BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNITY TOTAL PLUS POSTERIOR PROCEDURE PACK

    MDR report key: 23081633 · Received September 18, 2025

    Report

    Report Number
    1644019-2025-03468
    Event Type
    Malfunction
    Date Received
    September 18, 2025
    Date of Event
    August 26, 2025
    Report Date
    December 1, 2025
    Manufacturer
    ALCON RESEARCH, LLC - HOUSTON
    Product Code
    LRO
    UDI-DI
    00380650003317
    PMA / PMN Number
    K880961
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION PROVIDED IN D.9., H.3., H.6. AND H.11. THE TURBID POSTERIOR UNITY PAK WAS VISUALLY INSPECTED AND NO OBVIOUS DEFECTS WERE FOUND. THE PRODUCT WAS TESTED USING THE UNITY CONSOLE WITH THE CURRENT SOFTWARE. THE PRODUCT COULD PRIME SUCCESSFULLY. NO MESSAGE CODE APPEARED ON THE SCREEN. FLUID AIR EXCHANGE (FA/X) FUNCTION AT THE SETTING OF 30 MILLIMETERS OF MERCURY (MMHG) WAS PERFORMED ON THE INFUSION MANIFOLD FOR 5 TIMES WITH THE TIMER CL-054. WITH THE INFUSION CONTROL ON, FLUID FLOWED FROM THE CASSETTE CONTINUOUSLY WITHOUT GENERATING AIR TO THE INFUSION LINE. WHEN THE F/AX CONTROL WAS ON, ONLY AIR WAS INTRODUCED FROM THE CASSETTE TO THE INFUSION CANNULA LINE. THE INFUSION FLOW RATE WAS 31.1 CUBIC CENTIMETERS PER MINUTE BY TESTING WITH THE SCALE, WM-069. NO LEAKAGE OCCURRED DURING TESTING. THE MAX VACUUM LEVEL WAS -730.9 MMHG ON THE PRIME TEST RESULTS DATA. THE PRODUCT PASSED FUNCTIONALITY PER PROCEDURE. THE INVESTIGATION CONDUCTED A NON-CONFORMANCE REVIEW OF THE REPORTED LOT NUMBER. NO RELEVANT DEVIATIONS WERE IDENTIFIED, 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 AS THE PRODUCT FUNCTIONED PER SPECIFICATIONS. ADDITIONALLY, NO MANUFACTURING-RELATED DEFICIENCIES WERE FOUND THAT POTENTIALLY COULD HAVE CONTRIBUTED TO THE COMPLAINT. 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).

    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 NON-HEALTHCARE PROFESSIONAL REPORTED THAT SMALL AMOUNT OF BALANCED SALT SOLUTION ENTERED IN THE EYE WHILE ON FLUID AIR EXCHANGE DURING THE VITREO-RETINAL SURGERY. THE SURGERY WAS COMPLETED, AND THE PRODUCT REPLACEMENT DETAILS WERE UNKNOWN. THERE WAS NO IMPACT TO THE PATIENT. THERE WAS NO MEDICAL INTERVENTION REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2640249 UNITY TOTAL PLUS POSTERIOR PROCEDURE PACK GENERAL SURGERY TRAY (KIT) LRO ALCON RESEARCH, LLC - HOUSTON NA 17CMP6 00380650003317

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown