BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISCOUS FLUID CONTROL TUBING SET (SILICONE OIL INJ/EXT)

    MDR report key: 22815453 · Received August 15, 2025

    Report

    Report Number
    1644019-2025-02893
    Event Type
    Malfunction
    Date Received
    August 15, 2025
    Date of Event
    July 17, 2025
    Report Date
    September 30, 2025
    Manufacturer
    ALCON RESEARCH, LLC - HOUSTON
    Product Code
    GAZ
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION PROVIDED IN H.6. AND H.11. CORRECTED INFORMATION WAS UPDATED D.1., D.2 AND D.4. NO PRODUCT WAS RETURNED FOR THIS INVESTIGATION. THE REPORTED PRODUCT¿S LOT NUMBER WAS NOT REPORTED, PREVENTING LOT NUMBER SPECIFIC REVIEWS FOR SIMILAR COMPLAINTS OR NON-CONFORMANCES. HOWEVER, BEFORE PRODUCTION RELEASE, EACH PRODUCT HISTORY RECORD IS REVIEWED TO ENSURE THAT ALL ASSOCIATED PRODUCTS MEET THE REQUIRED SPECIFICATIONS AND RELEASE CRITERIA. THE ROOT CAUSE IS RELATED TO THE CUSTOMER NOT FOLLOWING THE DIRECTIONS-FOR-USE (DFU) INSTRUCTIONS BASED ON FOLLOW-UPS IN THIS REPORT. THE CUSTOMER WAS INFORMED ON CAUSE AND INSTRUCTED ON PROPER SET UP OF THE DEVICE. THE REPORT REVEALED THE DEVICE IS "WORKING GOOD." NO FURTHER INVESTIGATIVE OR MANUFACTURING ACTIONS ARE WARRANTED AT THIS TIME, BASED ON OUR CURRENT TRACKING, THERE ARE NO ADVERSE TRENDS FOR THIS REPORTED COMPLAINT AND LOT. 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). 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 DURING FINAL STAGE OF VITRECTOMY SURGERY, WHEN SILICONE OIL WAS INJECTED, AN OPHTHALMIC SYSTEM EXHIBITS THE UNUSUAL POPPING SOUND, AND THERE WAS A POTENTIAL OBSTRUCTION OR MECHANICAL ISSUE WITHIN THE SYSTEM, AND SIMULTANEOUSLY, THE MACHINE DISPLAYED AN ADVISORY CODE MULTIPLE TIMES STATING, ¿PRESSURE IS UNSTABLE, RELEASE THE FOOTSWITCH TREADMILL OR RESTART THE AGF. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AFTER PRESSING THE IGNORE ICON EACH TIME. NO PATIENT IMPACT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1240338 VISCOUS FLUID CONTROL TUBING SET (SILICONE OIL INJ/EXT) TUBING, NONINVASIVE GAZ ALCON RESEARCH, LLC - HOUSTON NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male CONSTELLATION VISION SYSTEM.| CUSTOM-PAK SURGICAL PROCEDURE PACK.