BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNITY VCS CONSOLE

    MDR report key: 23276218 · Received October 15, 2025

    Report

    Report Number
    2028159-2025-01520
    Event Type
    Malfunction
    Date Received
    October 15, 2025
    Date of Event
    September 16, 2025
    Report Date
    January 30, 2026
    Manufacturer
    ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    UDI-DI
    00380650002969
    PMA / PMN Number
    K233876
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED PROVIDED IN SECTIONS H.6., AND H.11. THE PRODUCT UNDER INVESTIGATION IS NOT A SERVICEABLE DEVICE. THEREFORE, A SERVICE RECORD REVIEW WAS NOT PERFORMED. THERE WAS NO PRODUCT RETURNED FOR THIS INVESTIGATION. BASED ON THE INFORMATION OBTAINED, THE ROOT CAUSE OF THE REPORTED EVENT IS INCONCLUSIVE. SPECIFIC PRODUCT IDENTIFIERS (SERIAL NUMBER) WERE NOT PROVIDED AND COULD NOT BE DETERMINED AT THIS TIME. HOWEVER, ALL DEVICE HISTORY RECORDS ARE REVIEWED PRIOR TO PRODUCT RELEASE TO ENSURE THE PRODUCT WAS MANUFACTURED IN COMPLIANCE WITH THE DEVICE MASTER RECORD AND MEETS RELEASE CRITERIA. A REVIEW FOR COMPLAINTS REPORTED AGAINST THIS SERIAL NUMBER CANNOT BE PERFORMED AS THE SERIAL NUMBER IS UNKNOWN. BASED ON THE INFORMATION OBTAINED, THE ROOT CAUSE OF THE REPORTED EVENT IS INCONCLUSIVE. MANUFACTURER WILL CONTINUE TO MONITOR DATA FOR EVIDENCE OF ADVERSE TRENDING AND TAKE FURTHER ACTION, AS APPROPRIATE. 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

    ADDITIONAL INFORMATION RECEIVED IN THE SECTION OF D.4, H.4, H.6 AND H.11 A MANUFACTURING DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED PRIOR TO PRODUCT RELEASE TO ENSURE THAT THE PRODUCT WAS MANUFACTURED IN COMPLIANCE WITH THE DEVICE MASTER RECORD. BASED ON THE ASSESSMENT, THE PRODUCT MET RELEASE CRITERIA. A NON-CONFORMANCE-BASED REVIEW OF THE SERIAL NUMBER WAS PERFORMED, AND NO DEVIATIONS WERE IDENTIFIED RELATED TO THIS REPORTED EVENT. A REVIEW OF COMPLAINTS REPORTED AGAINST THIS SERIAL NUMBER WAS PERFORMED. NO SIMILAR COMPLAINTS WERE REPORTED FOR THE PRODUCT SERIAL UNDER INVESTIGATION. SERVICE HISTORY WAS REVIEWED FOR THE SYSTEM. NO SERVICE RECORD RELEVANT TO THE COMPLAINT REPORTED EVENT WAS FOUND. HOWEVER, THE SYSTEM WAS LAST SERVICED PRIOR TO THE REPORTED EVENT PER SERVICE RECORD. THE SYSTEM WAS SERVICED FOR AN UNRELATED EVENT, THEN FOUND TO MEET ALL COSMETIC AND PERFORMANCE STANDARDS PER THE SERVICE TEST PROCEDURE (STP). BASED ON THE INFORMATION AVAILABLE, THE CUSTOMER REPORTED EVENT CANNOT BE CONFIRMED. BASED ON THE INFORMATION OBTAINED, THE ROOT CAUSE OF THE REPORTED EVENT IS INCONCLUSIVE. THE ROOT CAUSE OF THE REPORTED EVENT IS INCONCLUSIVE. THEREFORE, NO FURTHER ACTIONS WILL BE PURSUED AT THIS TIME. QUALITY ASSURANCE HAS REVIEWED THIS COMPLAINT AND WILL CONTINUE TO MONITOR DATA FOR EVIDENCE OF ADVERSE TRENDING AND TAKE FURTHER ACTION, AS APPROPRIATE. RECEIPT OF COMPLAINT SAMPLE OR ADDITIONAL INFORMATION PERTINENT TO THIS COMPLAINT WILL RESULT IN RE-EVALUATION OF THE COMPLAINT INVESTIGATION. SIMILAR INCIDENT/EVENT DATA WAS COLLECTED FOR THE ASSOCIATED REPORTED EVENTS. QUALITY ASSURANCE WILL CONTINUE TO PERFORM PERIODIC MONITORING FOR EVIDENCE OF ADVERSE TRENDING AND TAKE FURTHER ACTION AS APPROPRIATE. 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 SURGERY, AN OPHTHALMIC CONSOLE EXHIBITED AN ISSUE WITH FLUCTUATED ASPIRATION (GOING UP AND DOWN) DURING PHACOEMULSIFICATION. DURING IRRIGATION AND ASPIRATION (I/A) THERE WAS NO ISSUES. THE PROCEDURE WAS COMPLETED USING THE SAME PAK. NO PATIENT HARM HAS BEEN REPORTED. THIS REPORT PERTAINS TO ONE OF THE TWO REPORTS FROM THE SAME FACILITY AND INVOLVES THE OPHTHALMIC CONSOLE ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180173 UNITY VCS CONSOLE UNIT, PHACOFRAGMENTATION HQC ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER NA 17CDAY 00380650002969

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown UNITY CATARACT FMS PROCEDURE PACK