BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLAREON IOL

    MDR report key: 23665228 · Received November 27, 2025

    Report

    Report Number
    9612169-2025-02365
    Event Type
    Malfunction
    Date Received
    November 27, 2025
    Date of Event
    October 20, 2025
    Report Date
    February 16, 2026
    Manufacturer
    ALCON LABORATORIES IRELAND LTD.
    Product Code
    HQL
    UDI-DI
    00380652251518
    PMA / PMN Number
    P190018
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS PROVIDED IN D.9., H.3., H.6. AND H.11. IOL RETURNED PRESSED AGAINST TWO POSTS OF THE LENS CASE BASE. SOLUTION IS DRIED ON THE IOL. ONE HAPTIC IS BROKEN/TORN AND NOT RETURNED, THE OTHER HAPTIC IS DEFORMED. THE OPTIC IS DEFORMED. A USED COMPANY CARTRIDGE WAS RETURNED. INADEQUATE VISCOELASTIC WAS OBSERVED IN THE CARTRIDGE. NO CARTRIDGE DAMAGE WAS OBSERVED. THE CARTRIDGE HAD EVIDENCE OF PLACEMENT INTO A HANDPIECE. THE USED COMPANY CARTRIDGE WAS CLEANED FOR FURTHER EVALUATION. TOPCOAT DYE STAIN TESTING WAS CONDUCTED WITH ACCEPTABLE RESULTS. PROVIDED PHOTO SHOWS COMPANY CARTRIDGE AND AN IOL IN A LENS CASE BASE. THE LENS IS NOT POSITIONED CORRECTLY IN THE LENS CASE BASE WELL; IT APPEARS TO BE PRESSED AGAINST THREE POSTS OF THE WELL. ONE HAPTIC IS BROKEN AND SEPARATED FROM THE OPTIC. THE LENS OPTIC EDGE APPEARS TO BE DAMAGED. THE COMPANY CARTRIDGE WAS SHOWN FROM THE BOTTOM. THERE DID NOT APPEAR TO BE ADEQUATE VISCOELASTIC IN THE CARTRIDGE. NO DAMAGE WAS OBSERVED. IT CANNOT BE VERIFIED IF THE CARTRIDGE WAS PROPERLY SEATED IN A HANDPIECE AS THE VIEW WAS FROM THE BOTTOM. THE ROOT CAUSE FOR THE REPORTED COMPLAINT APPEARS TO BE RELATED THE A FAILURE TO FOLLOW THE INSTRUCTIONS FOR USE (IFU). INADEQUATE VISCOELASTIC WAS OBSERVED IN THE CARTRIDGE. THE IFU INSTRUCTS TO COMPLETELY FILL THE CARTRIDGE WITH OVD IMMEDIATELY PRIOR TO LOADING AND DELIVERY OF THE LENS. DO NOT ATTEMPT TO LOAD THE LENS WITHOUT ADEQUATE OVD IN THE DEVICE. NOT ADEQUATELY FILLING THE DEVICE WITH VISCOELASTIC WILL RESULT IN INADEQUATE COVERAGE OF LENS AND THE LENS FOLD PATH WITH OVD, WHICH MAY RESULT IN DAMAGE. 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 HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE THE HAPTIC WAS BROKEN, THE LENS WAS IMPLANTED IN THE PATIENT EYE. THE SURGERY WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570852 CLAREON IOL INTRAOCULAR LENS HQL ALCON LABORATORIES IRELAND LTD. SY60WF 25905779 00380652251518

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown CLAREON MONARCH IV IOL DELIVERY SYSTEM, INJECTOR.| MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D.| VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE.