BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLAREON IOL WITH THE AUTONOME DELIVERY SYSTEM

    MDR report key: 22858462 · Received August 21, 2025

    Report

    Report Number
    9612169-2025-01678
    Event Type
    Malfunction
    Date Received
    August 21, 2025
    Date of Event
    August 12, 2025
    Report Date
    November 17, 2025
    Manufacturer
    ALCON LABORATORIES IRELAND LTD.
    Product Code
    HQL
    UDI-DI
    00380652393805
    PMA / PMN Number
    P190018
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    003

    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).

    Additional Manufacturer Narrative · 0

    CORRECTION INFORMATION WAS PROVIDED IN H.6. (FDA PRODUCT CODE A040603 WAS ADDED) ADDITIONAL INFORMATION WAS PROVIDED IN B.3., B.5., D.9., H.3., H.6., AND H.11. THE PRODUCT WAS RETURNED FOR ANALYSIS AND STRAIGHT LEADING HAPTIC WAS OBSERVED. THE DEVICE WAS RECEIVED IN AN OPENED BLISTER TRAY INSIDE THE PRODUCT CARTON. SOLUTION IS DRIED IN THE DEVICE. THE LOCK-OUT ASSEMBLY HAS BEEN REMOVED. THE PLUNGER AND THE LENS HAVE BEEN ADVANCED INTO THE MID-NOZZLE. THE PLUNGER POSITION IS ACCEPTABLE. THE TRAILING HAPTIC IS FOLDED ONTO THE OPTIC. THE LEADING HAPTIC IS EXTENDED STRAIGHT. THE PLUNGER, LENS AND HAPTIC POSITIONS ARE ACCEPTABLE. THE PRESENTATION OF STRAIGHT-LEADING HAPTICS IS ADDRESSED IN THE PRODUCT INSTRUCTIONS FOR USE (IFU), WHERE IT IS PROVIDED THAT DELIVERY MAY PROCEED WITH CAUTION AND SHOULD BE MANAGED BASED ON THE OUTLINED INSTRUCTIONS. WHILE STRAIGHT LEADING HAPTICS MAY OCCASIONALLY OCCUR, CLOSE ADHERENCE TO THE IFU PROVIDES THE BEST OPPORTUNITY FOR OPTIMAL DELIVERY. POSSIBLE ASSOCIATED FACTORS MAY ALSO INCLUDE: USE OF A NON-QUALIFIED VISCOELASTIC OR BSS IN THE DELIVERY SYSTEM. MATERIAL PROPERTIES OF NON-QUALIFIED OVDS (OPHTHALMIC VISCOSURGICAL DEVICE) MAY CONTRIBUTE TO UNDERFILL, OVERFILL, MISFOLDING OF THE HAPTICS, OR OTHER INCONSISTENT FOLDING OUTCOMES. EXCESSIVE DELAY BETWEEN DEVICE PREPARATION AND SUBSEQUENT DELIVERY RESULTING IN THE POTENTIAL FOR HAPTIC UNFOLDING. USE OF THE DELIVERY SYSTEM AT OPERATING ROOM TEMPERATURES OUTSIDE OF THE RECOMMENDED RANGE OF 18 DEGREE CELSIUS (64-DEGREE FAHRENHEIT) TO 23 °C (73-DEGREE FAHRENHEIT). OVD SHOULD BE ALLOWED TO COME TO OPERATING ROOM TEMPERATURE OVER A 20-MINUTE TIMEFRAME PRIOR TO USE. ANY OF THE ABOVE FACTORS ALONE, OR IN COMBINATION, MAY LEAD TO AN EVENT SUCH AS REPORTED. BASED ON THE RESULTS FROM THE PRODUCT HISTORY RECORD, THE PRODUCTS MET RELEASE CRITERIA. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THERE WAS HAPTIC FAILURE WHILE LOADING THE LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING THAT THERE HAD BEEN AN IMPROPER FOLD AND THE PROCEDURE WAS COMPLETED ON THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    443111 CLAREON IOL WITH THE AUTONOME DELIVERY SYSTEM INTRAOCULAR LENS HQL ALCON LABORATORIES IRELAND LTD. CNA0T0 25981055 00380652393805

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown