BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLAREON IOL WITH THE AUTONOME DELIVERY SYSTEM

    MDR report key: 21446097 · Received February 24, 2025

    Report

    Report Number
    9612169-2025-00256
    Event Type
    Malfunction
    Date Received
    February 24, 2025
    Report Date
    February 24, 2025
    Manufacturer
    ALCON LABORATORIES IRELAND LTD.
    Product Code
    HQL
    UDI-DI
    00380652397827
    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 PRODUCT WAS RETURNED FOR ANALYSIS AND THE REPORTED COMPLAINT COULD NOT BE CONFIRMED. THE DEVICE WAS RECEIVED LOOSE IN THE PRODUCT CARTON. SOLUTION IS DRIED IN THE DEVICE. THE LOCK-OUT ASSEMBLY HAS BEEN REMOVED. THE PLUNGER HAS BEEN FULLY ADVANCED OUTSIDE THE NOZZLE TIP. NO DAMAGE OBSERVED. THE LENS WAS RECEIVED OUTSIDE OF THE DEVICE IN A PLASTIC BAG. THE LEVER IS MOVING FREELY. THE DEVICE IS TAKEN APART FOR FURTHER TESTING. NO DAMAGE OBSERVED TO THE INTERNAL PARTS OF THE DEVICE. THE DEVICE WAS RELOADED AND WAS REACTIVATED WITH A NEW CANISTER. THE FAILURE MODE COULD NOT BE REPLICATED; THE DEVICE ACTIVATED WITH NO ISSUES, NO PROBLEMS WITH PLUNGER SPEED OBSERVED. WE ARE UNABLE TO DETERMINE THE ROOT CAUSE FOR THE REPORTED COMPLAINT LENS WAS ADVANCED FASTER THAN NORMAL. THE DEVICE WAS RETESTED WITH A NEW GAS CANISTER, NO ISSUES WITH ACTIVATION OR PLUNGER ADVANCEMENT/PLUNGER SPEED OBSERVED. FAILURE MODE COULD NOT BE REPLICATED. NO DAMAGE OBSERVED TO THE INTERNAL PARTS OF THE AUTONOME DEVICE. THE DEVICE PERFORMANCE AT THE TIME OF THE ACTIVATION IN CUSTOMERS' FACILITY CANNOT BE CONFIRMED. BASED ON THE RESULTS FROM THE PRODUCT HISTORY RECORD, THE PRODUCTS MET RELEASE CRITERIA. 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 NON HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, STAFFER PERFORMED SETTING AS USUAL USING ANOTHER COMPANY FOR BACK-UP AGAIN AND ADVANCED THE LENS. ONCE MORE, THE LENS WAS ADVANCED FASTER THAN USUAL, REPORTEDLY. WHEN IT WAS HANDED OVER TO DOCTOR AND STARTED IMPLANTING IT, DOCTOR REALIZED THAT IT WAS ADVANCED FASTER THAN USUAL AND STOPPED IMPLANTING IT. THE LENS WAS NOT INSERTED INTO A PATIENT'S EYE. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT SURGEON PERCEIVED THAT THE PLUNGER WAS ADVANCING FASTER THAN NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413929 CLAREON IOL WITH THE AUTONOME DELIVERY SYSTEM INTRAOCULAR LENS HQL ALCON LABORATORIES IRELAND LTD. CNA0T0 25883293 00380652397827

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown