BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLAREON IOL WITH THE AUTONOME DELIVERY SYSTEM

    MDR report key: 23805158 · Received December 15, 2025

    Report

    Report Number
    9612169-2025-02519
    Event Type
    Malfunction
    Date Received
    December 15, 2025
    Date of Event
    November 10, 2025
    Report Date
    March 4, 2026
    Manufacturer
    ALCON LABORATORIES IRELAND LTD.
    Product Code
    HQL
    UDI-DI
    00380652397841
    PMA / PMN Number
    P190018
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FDA PRODUCT CODE OF A141401 WAS MISSED TO SUBMIT IN THE PREVIOUSLY SUBMITTED MDR. THE PRODUCT WAS RETURNED FOR ANALYSIS, AND THE REPORTED COMPLAINT COULD NOT BE CONFIRMED. THE DEVICE WAS RETURNED ADHERED TO A PIECE OF CARD. THE LOCK-OUT ASSEMBLY HAS BEEN REMOVED. VISCOELASTIC IS OBSERVED IN THE DEVICE. THE PLUNGER HAS BEEN ADVANCED ALMOST TO THE NOZZLE TIP. THE NOZZLE TIP IS CRUSHED. IOL (INTRAOCULAR LENS) WAS NOT RETURNED. THE LEVER WAS PRESSED AS PART OF THE EVALUATION, NO GAS HEARD AND NO PLUNGER MOVEMENT. THE DEVICE WAS SENT FOR FURTHER ANALYSIS. COMPLAINTS HAVE BEEN RECEIVED DESCRIBING THAT GAS WAS HEARD DURING ACTIVATION, WHICH LED TO SLOWER PLUNGER MOVEMENT/ PLUNGER STOPPED IN SOME CASES. THE ROOT CAUSE IS DEEMED TO BE VENDOR RELATED. THE MOST LIKELY ROOT CAUSE IS PARTIAL GAS LEAK PASSING THE CANISTER O-RING, WHICH RESULTS IN LIQUID CO2 ESCAPING OUTSIDE OF THE DEVICE AND WHILE COOLING PRODUCES A VISIBLE PLUME. NO COMPONENT OR PROCESS HAS BEEN IDENTIFIED AS BEING ROOT CAUSE BUT WITH THE DEFINED ASSEMBLY TIMELINE CORRELATING WITH THESE INSTANCES, LIKELY ROOT CAUSE IS THE ASSEMBLY PROCESS AND PARTICULARLY THE FINAL ASSEMBLY. DUE TO UNKNOWN NATURE OF THE ROOT CAUSE THERE IS NO PROPOSED CORRECTIVE ACTION AT THIS TIME. AS PER THE INSTRUCTIONS FOR USE (IFU), THE LENS SHOULD BE INSPECTED AT THE PAUSE LOCATION PRIOR IMPLANTATION. BASED ON THE RESULTS FROM COMPANY PRODUCT HISTORY RECORD, THE PRODUCTS MET RELEASE CRITERIA. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; THE LENS REMAINS IMPLANTED. COMPLAINT HISTORY AND PRODUCT HISTORY RECORDS WERE REVIEWED AND DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. ROOT CAUSE HAS NOT BEEN IDENTIFIED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A PHYSICIAN REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, AN INJECTOR DID NOT WORK PROPERLY. BEFORE IOL INSERTION, AN AIR LEAKING SOUND WAS HEARD A BIT AND DURING INSERTION, THE PRODUCT STOPPED HALFWAY. IT WAS ALREADY INSERTED HALF, SO INSERTED COMPLETELY USING A FORCEPS AND SURGERY WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273059 CLAREON IOL WITH THE AUTONOME DELIVERY SYSTEM INTRAOCULAR LENS HQL ALCON LABORATORIES IRELAND LTD. CNA0T0 26029185 00380652397841

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown CENTURION VISION SYSTEM| VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE