BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLAREON IOL WITH THE AUTONOME DELIVERY SYSTEM

    MDR report key: 20642230 · Received November 8, 2024

    Report

    Report Number
    9612169-2024-01143
    Event Type
    Malfunction
    Date Received
    November 8, 2024
    Date of Event
    October 1, 2024
    Report Date
    March 14, 2025
    Manufacturer
    ALCON LABORATORIES IRELAND LTD.
    Product Code
    HQL
    UDI-DI
    00380652396462
    PMA / PMN Number
    P190018
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION HAS BEEN PROVIDED IN H.3., H.6. AND H.11. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. THE REPORTER STATES THE USE OF NON COMPANY AS VISCOELASTIC, WHICH IS NOT QUALIFIED TO BE USED WITH THE ASSOCIATED PRODUCT. THE REPORTED COMPLAINT WAS NOT OBSERVED AS NO SAMPLE WAS RETURNED FOR ANALYSIS; HOWEVER, BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER, THE MOST LIKELY ROOT CAUSE IS FAILURE TO FOLLOW INSTRUCTIONS FOR USE (IFU), AS THE SURGEON STATES THE USE OF NON-QUALIFIED VISCOELASTIC. THE USE OF AN UNQUALIFIED COMBINATION MAY CAUSE DAMAGE TO THE INTRAOCULAR LENS (IOL) AND POTENTIAL COMPLICATIONS DURING THE IMPLANTATION PROCESS. 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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION PROVIDED H.3., H.6. AND H.11. THE PRODUCT WAS RETURNED FOR ANALYSIS AND THE REPORTED COMPLAINT COULD NOT BE OBSERVED. THE DEVICE WAS RETURNED LOOSE IN THE CARTON. THE LOCK-OUT ASSEMBLY HAS BEEN REMOVED. VISCOELASTIC IS OBSERVED IN THE DEVICE. THE PLUNGER HAS BEEN ADVANCED TO THE NOZZLE TIP. NO IOL RETURNED. THE REPORTER STATES THE USE OF "NUVISC" AS VISCOELASTIC, WHICH IS NOT QUALIFIED TO BE USED WITH THE ASSOCIATED PRODUCT. WHILE WE ARE UNABLE TO DETERMINE THE ORIGIN OF THE REPORTED COMPLAINT, OUR OBSERVATIONS REASONABLY SUGGEST THAT IT IS NOT MANUFACTURING RELATED. BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER, THE MOST LIKELY ROOT CAUSE IS FAILURE TO FOLLOW IFU, AS THE CUSTOMER STATES THE USE OF NON-QUALIFIED VISCOELASTIC. THE USE OF AN UNQUALIFIED OVD MAY CAUSE DAMAGE TO THE LENS AND POTENTIAL COMPLICATIONS DURING THE IMPLANTATION PROCESS. 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.

    Additional Manufacturer Narrative · 0

    CORRECTION INFORMATION HAS BEEN PROVIDED IN H.6. H.6. (FDA EVALUATION CODES C0602 AND D10 ADDED). ADDITIONAL INFORMATION HAS BEEN PROVIDED IN D.9. AND H.3. 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 PROVIDED IN B.5., D.10 AND H.6. 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

    A PRODUCT WAS NOT RETURNED FOR ANALYSIS. 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). 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

    ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THE IMPLANT WAS INJECTED, BUT IT WOULD NOT COME OUT DESPITE PERFECT PREPARATION OF THE INJECTOR. THE PLUNGER PASSED BESIDE THE IMPLANT. THE PROCEDURE WAS COMPLETE WITH ANOTHER COMPANY LENS.

    Description of Event or Problem · 0

    A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTED THAT THE LENSES GOT STUCK AT THE END OF THE INJECTOR TWICE WITH THE SAME PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THIS REPORT IS ASSOCIATED WITH MULTIPLE COMPLAINTS. THIS FILE IS 1 OF 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1952949 CLAREON IOL WITH THE AUTONOME DELIVERY SYSTEM INTRAOCULAR LENS HQL ALCON LABORATORIES IRELAND LTD. CNA0T0 25801230 00380652396462

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown NUVISC