BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLAREON ASPHERIC UV ABSORBING IOL

    MDR report key: 23876227 · Received December 23, 2025

    Report

    Report Number
    1119421-2025-03212
    Event Type
    Malfunction
    Date Received
    December 23, 2025
    Date of Event
    October 27, 2025
    Report Date
    December 23, 2025
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    HQL
    UDI-DI
    00380652396837
    PMA / PMN Number
    P190018
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE SAMPLE WAS NOT RETURNED FOR AN EVALUATION. A DEVICE HISTORY RECORD REVIEW AND A NON-CONFORMANCE REVIEW OF THE REPORTED LOT NUMBER WAS CONDUCTED. THE DEVIATION REVIEW DID NOT REVEAL ANY POTENTIAL CONTRIBUTING FACTORS TO THE REPORTED COMPLAINT AND ALL CORRESPONDING PRODUCTION RELEASE SPECIFICATIONS DEFINED IN THE DEVICE MASTER RECORD WERE MET. A QUALIFIED CARTRIDGE, HANDPIECE, AND VISCOELASTIC WERE USED. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE FOR THE REPORTED COMPLAINT. THE SAMPLE WAS NOT AVAILABLE TO RETURN. INFORMATION WAS PROVIDED THAT THE BENT HAPTIC WAS FOUND DURING LOADING. THE IFU INSTRUCTS: USING HOLDING FORCEPS, GRASP THE LENS BY THE OPTIC EDGE AND GENTLY PLACE THE LENS ANTERIOR SIDE UP INTO THE BACK OF THE OVD-FILLED CARTRIDGE. THE LENS SHOULD BE INSERTED UNTIL THE OPTIC IS A LITTLE MORE THAN HALF-WAY INSIDE THE CARTRIDGE. USE THE HOLDING FORCEPS TO GENTLY PUSH DOWN ON THE LENS, VERIFYING THAT THE LENS IS ON THE BOTTOM SURFACE OF THE CARTRIDGE. USING HOLDING FORCEPS, TAKE THE TRAILING HAPTIC, AND GENTLY FOLD THE HAPTIC ONTO THE ANTERIOR SIDE OF THE OPTIC. SLOWLY GRIP OR PUSH THE OPTIC EDGE TO POSITION THE LENS AS FAR INTO THE CARTRIDGE AS THE FORCEPS WILL PERMIT, WHILE ENSURING THE LENS REMAINS ON THE BOTTOM SURFACE OF THE CARTRIDGE AND THE TRAILING HAPTIC REMAINS ON THE OPTIC. FAILURE TO FOLLOW THESE STEPS MAY CAUSE THE LENS TO ADVANCE INCORRECTLY CAUSING DELIVERY ISSUES AND/OR DAMAGE. IT IS UNKNOWN IF ADEQUATE VISCOELASTIC WAS USED. 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. THE IFU INSTRUCTS: FOLLOW THE SECTION REGARDING DIRECTIONS FOR USE FOR INFORMATION ON THE MAXIMUM ALLOWED TIME FOR THE IOL TO STAY IN THE FOLDED CONDITION. FAILURE TO ADHERE TO MANUFACTURER¿S RECOMMENDATIONS MAY RESULT IN IOL DAMAGE. IFU NOTE: DURING LENS LOADING AND INSERTION, DO NOT ALLOW THE CLAREON IOL TO REMAIN IN A FOLDED CONDITION WITHIN THE SELECTED IOL DELIVERY SYSTEM FOR MORE THAN 3 MINUTES PRIOR TO COMPLETING INSERTION INTO THE CAPSULAR BAG. INFORMATION WAS PROVIDED THAT ANOTHER CC60WF 20.5 DIOPTER LENS WAS USED TO COMPLETE THE SURGERY. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, A BENT HAPTIC WAS OBSERVED. THERE WAS NO PATIENT CONTACT OR HARM, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE SAME MODEL LENS. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2531851 CLAREON ASPHERIC UV ABSORBING IOL INTRAOCULAR LENS HQL ALCON RESEARCH, LLC - HUNTINGTON CC60WF 16069593 00380652396837

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male MONARCH III IOL CARTRIDGE D| MONARCH III IOL INJECTOR| PROVISC OVD