BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLAREON IOL WITH THE AUTONOME DELIVERY SYSTEM

    MDR report key: 23577927 · Received November 17, 2025

    Report

    Report Number
    9612169-2025-02290
    Event Type
    Malfunction
    Date Received
    November 17, 2025
    Date of Event
    October 18, 2025
    Report Date
    February 3, 2026
    Manufacturer
    ALCON LABORATORIES IRELAND LTD.
    Product Code
    HQL
    UDI-DI
    00380652393751
    PMA / PMN Number
    P190018
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION INFORMATION PROVIDED IN H.6. (A141401 HAS BEEN ADDED). ADDITIONAL INFORMATION PROVIDED IN H.3., H.6. AND H.11. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. ONLY PHOTO WAS RETURNED. DAMAGE TO THE LENS WAS OBSERVED. PHOTO PROVIDED SHOWS AN IOL (INTRAOCULAR LENS) ON WHAT APPEARS TO BE A COMPANY SPECIFIC NOZZLE. THE LENS BAY DOOR APPEARS TO BE OPEN. THERE APPEARS TO BE DAMAGE TO BOTH HAPTICS AND TO THE OPTIC. THE REPORTED COMPLAINT "LENS STUCK HALFWAY DOWN THE PATH, PLUNGER MADE CONTACT WITH THE OPTIC", CANNOT BE CONFIRMED FROM THE PROVIDED PHOTO. DAMAGE TO THE LENS WAS OBSERVED. A DEFINITIVE DETERMINATION OF THE REPORTED COMPLAINT CANNOT BE MADE WITHOUT THE EVALUATION OF THE PHYSICAL PRODUCT. A FINAL ROOT CAUSE CANNOT BE DETERMINED BASED ON AVAILABLE INFORMATION. LENS MAY BECOME STUCK IN THE DEVICE: ¿ IF INADEQUATE VISCOELASTIC IS PLACED IN THE DEVICE THIS WILL CAUSE INADEQUATE COVERAGE OF THE LENS FOLD PATH WHICH MAY CAUSE THE LENS TO BECOME ¿STUCK¿ IN THE DEVICE ¿ DUE TO THE USE OF A NON-QUALIFIED VISCOELASTIC. MATERIAL PROPERTIES OF NON-QUALIFIED OVDS (OPHTHALMIC VISCOSURGICAL DEVICE) MAY CONTRIBUTE TO UNDERFILL, OVERFILL, MISFOLDING OF THE HAPTICS, OR OTHER INCONSISTENT FOLDING OUTCOMES. ¿ IF THE OPERATING ROOM TEMPERATURE IS TOO HIGH (MORE THAN 23 DEGREE CELSIUS / 73-DEGREE FAHRENHEIT) LENS FOLDING CONSISTENCY IS NEGATIVELY AFFECTED, THE LENS IS MORE ADHERENT, AND THIS MAY INHIBIT LENS ADVANCEMENT. ANY OF THE ABOVE LISTED CAUSES ALONE, OR IN COMBINATION, MAY CREATE THE REPORTED EVENT. BASED ON THE RESULTS FROM THE PRODUCT HISTORY RECORD, THE PRODUCTS MET RELEASE CRITERIA. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    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).

    Description of Event or Problem · 0

    A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE; WHILE ADVANCING THE LENS TO THE STANDBY POSITION, IT BECAME STUCK MIDWAY ALONG THE PATH AND COULD NOT PROCEED TO THE PAUSE MARK. THE LENS WAS IMMEDIATELY SET ASIDE, AND ANOTHER LENS WAS OPENED FOR USE. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THAT, WHEN THE INJECTION WAS ACTIVATED, THE STEM ENTERED AT AN ANGLE AND INSTEAD OF ENGAGING THE HAPTIC, IT PUSHED THE OPTIC, LEAVING THE HAPTIC BEHIND AND CAUSING DAMAGE TO THE LENS. THE PROCEDURE WAS COMPLETED ON THE SAME DAY WITHOUT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1494374 CLAREON IOL WITH THE AUTONOME DELIVERY SYSTEM INTRAOCULAR LENS HQL ALCON LABORATORIES IRELAND LTD. CNA0T0 26042140 00380652393751

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE