BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLAREON ASPHERIC HYDROPHOBIC ACRYLIC IOL

    MDR report key: 23840048 · Received December 18, 2025

    Report

    Report Number
    1119421-2025-03172
    Event Type
    Malfunction
    Date Received
    December 18, 2025
    Date of Event
    November 17, 2025
    Report Date
    December 18, 2025
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    HQL
    UDI-DI
    00380652251495
    PMA / PMN Number
    P190018
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ONLY THE LENS CARTON WITH THE EXTRA PRODUCT LABELING STICKER SET WAS RETURNED. 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 AND HANDPIECE WERE USED WITH A NON-QUALIFIED VISCOELASTIC. ONLY THE EMPTY LENS CARTON WAS RETURNED. THE ROOT CAUSE FOR THE REPORTED COMPLAINT MAY BE RELATED TO A FAILURE TO FOLLOW THE IFU (INSTRUCTIONS FOR USE). A NON-QUALIFIED VISCOELASTIC WAS USED. THE IFU INSTRUCTS: COMPANY FOLDABLE IOLS (INTRAOCULAR LENS) ARE QUALIFIED FOR USE WITH AN COMPANY QUALIFIED DELIVERY SYSTEM (HANDPIECE AND CARTRIDGE) AND OPHTHALMIC VISCOSURGICAL DEVICE (OVD) COMBINATION. THE IFU INSTRUCTS THAT AN COMPANY QUALIFIED DELIVERY SYSTEM AND VISCOELASTIC COMBINATION SHOULD BE USED. THE USE OF AN UNQUALIFIED COMBINATION MAY CAUSE DAMAGE TO THE LENS AND POTENTIAL COMPLICATIONS DURING THE IMPLANTATION PROCESS. 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. 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. IMPORTANT: THE PLUNGER SHOULD MAKE INITIAL CONTACT WITH THE CARTRIDGE AT THE RAMP. IN THE EVENT THE PLUNGER DOES NOT CONTACT THE CARTRIDGE AT THE RAMP, DO NOT USE THE HANDPIECE AND CONTACT THE COMPANY. THE HANDPIECE IFU INSTRUCTS: VERIFY THAT THE PLUNGER TIP IS PROPERLY ENGAGING THE LENS OPTIC AND THAT THE LENS MOVES FORWARD AT THE SAME RATE AS THE PLUNGER WHILE SLOWLY ADVANCING THE PLUNGER FORWARD TO AVOID DAMAGING THE LENS. WHEN THE THREADS ON THE KNOB MAKE CONTACT WITH THE BARREL, TURN THE KNOB CLOCKWISE APPROXIMATELY ½ TURN TO ENGAGE THE THREADS AND THEN STOP. THE IOL WILL NOW BE IN THE DWELL POSITION. INSPECT TO ENSURE THE PLUNGER IS BEHIND THE OPTIC. 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

    A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHEN PLACING THE FIRST LENS, THERE HAD IMMEDIATELY BEEN AN ISSUE AND IT HAD TO BE REMOVED. THE ISSUE WITH THE FIRST ONE WAS THAT THE TRAILING HAPTIC HAD BEEN CRACKED AND THE LEADING HAPTIC HAD BEEN DEFECTIVE IT HADN'T BEEN SHAPED RIGHT. THE BACKUP LENS HAD BEEN COMPLETELY CEMENTED INTO THE CARTRIDGE AND HAD NOT BUDGED. THE PROCEDURE WAS COMPLETED WITH A NON COMPANY LENS ON THE SAME DAY. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256197 CLAREON ASPHERIC HYDROPHOBIC ACRYLIC IOL INTRAOCULAR LENS HQL ALCON RESEARCH, LLC - HUNTINGTON SY60WF 16083583 00380652251495

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Female HEALON PRO OVD| J&J REPLACEMENT IOL| MONARCH II LOADING FORCEPS| MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D| MONARCH III IOL DELIVERY SYSTEM, INJECTOR