BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLAREON ASPHERIC UV ABSORBING IOL

    MDR report key: 21546091 · Received March 7, 2025

    Report

    Report Number
    1119421-2025-00623
    Event Type
    Malfunction
    Date Received
    March 7, 2025
    Date of Event
    February 4, 2025
    Report Date
    April 28, 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
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A PRODUCT WAS NOT RETURNED FOR ANALYSIS, THE LENS REMAINS IMPLANTED. 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). H.10 REFLECTS ALL RELATED REPORT NUMBERS ASSOCIATED WITH THIS PRODUCT EVENT THAT HAVE BEEN SUBMITTED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS NOT RETURNED. A PHOTO WAS PROVIDED TITLED FERGUSON OPTIC EDGE. THE PHOTO WAS OF A MONITOR SCREEN. A SINGLE-PIECE LENS WAS VISIBLE IN THE EYE. THE FULL LENS WAS NOT VISIBLE. TWO SCUFFED AREAS WERE OBSERVED ON THE EDGE ON OPPOSITE SIDES OF THE ANTERIOR SURFACE. PRODUCT HISTORY RECORDS WERE REVIEWED, AND THE DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. THE ACCOUNT INDICATED THE USE OF QUALIFIED ASSOCIATED PRODUCTS. BASED ON OUR OBSERVATION OF THE ATTACHED PHOTO, THE LENS APPEARS TO HAVE A SMALL MARK ON THE OPTIC. THE LENS REMAINED IMPLANTED IN THE EYE. IT IS DIFFICULT TO MAKE A FINAL DETERMINATION WITHOUT EVALUATION OF THE PHYSICAL SAMPLE. THE ROOT CAUSE CANNOT BE DETERMINED BASED ON AVAILABLE INFORMATION. THE ACCOUNT INDICATED THE ASSOCIATED CARTRIDGE WAS DISCARDED. THE INSTRUCTIONS FOR USE (IFU) INSTRUCTS TO COMPLETELY FILL THE CARTRIDGE WITH OPHTHALMIC VISCOSURGICAL DEVICES (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: 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: FOLLOW THE SECTION REGARDING DIRECTIONS FOR USE FOR INFORMATION ON THE MAXIMUM ALLOWED TIME FOR THE INTRAOCULAR LENS (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 COMPANY 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. DUE DILIGENCE HAS BEEN PERFORMED IN AN ATTEMPT TO OBTAIN FURTHER INFORMATION ON THIS EVENT. THE REPORTER HAS NOT RESPONDED TO REQUESTS FOR FOLLOW-UP INFORMATION. FILE WILL BE REOPENED IF NEW INFORMATION IS RECEIVED. 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 HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, UPON IMPLANTATION, EDGE DAMAGE OBSERVED ON THE IOL. LENS WAS LEFT IN THE EYE.ADDITIONAL INFORMATION HAS BEEN REQUESTED.THERE ARE FIVE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS FILE IS 2 OF 5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437201 CLAREON ASPHERIC UV ABSORBING IOL INTRAOCULAR LENS HQL ALCON RESEARCH, LLC - HUNTINGTON CC60WF 15908563 00380652396837

    Patients

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