BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLAREON ASPHERIC HYDROPHOBIC ACRYLIC IOL

    MDR report key: 20856435 · Received December 5, 2024

    Report

    Report Number
    1119421-2024-02386
    Event Type
    Malfunction
    Date Received
    December 5, 2024
    Date of Event
    November 4, 2024
    Report Date
    April 15, 2025
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    HQL
    UDI-DI
    00380652251440
    PMA / PMN Number
    P190018
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    003

    Narratives

    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). H.10 REFLECTS ALL RELATED REPORT NUMBERS ASSOCIATED WITH THIS PRODUCT EVENT THAT HAVE BEEN SUBMITTED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS PROVIDED IN H.3.,H.6 AND H.11. A PHOTO WAS PROVIDED OF A LENS INSIDE THE EYE. THE SCREEN VIEW SHOWS THE MULTIPLE LINES OF THE MONITOR SCREEN. THE GLARE FROM OVERHEAD LIGHTING WAS OBSERVED ON THE LENS. ALL OF THE OPTIC AND THE GUSSET AREA OF ONE HAPTIC CAN BE VIEWED IN THIS PHOTO. THERE APPEARS TO BE A STUTTER SCRATCH TRAVELLING FORWARD, LOCATED NEAR THE OPTIC EDGE. ASSOCIATED PRODUCT INFORMATION WAS NOT PROVIDED. IT IS UNKNOWN IF QUALIFIED PRODUCTS WERE USED. A PHOTO WAS PROVIDED OF THE LENS DAMAGE. THE DAMAGE OBSERVED WAS SIMILAR IN NATURE TO DAMAGE DETECTED USING CAVITY 173 COMPANY CARTRIDGES. 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-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HAVING SOME ISSUES LENS BEING SCRATCHED. IT HAPPENED TODAY WITH TWO DIFFERENT TECHS. BUT THE FIRST TIME IT HAPPENED IT WAS IN THE CENTER OF THE LENS, THAT ONE WAS REMOVED AND A NEW ONE PLACED, THE SECOND LENS HAD AN ALMOST IDENTICAL MARK ON IT. SO IT HAD TO BE REPLACED AS WELL. WE SWAPPED OUT CARTRIDGES, THINKING IT COULD BE A FLAW IN A LOT NUMBER, BUT IT STILL HAPPENED. IT HAS HAPPENED WITH DIFFERENT SIZES AND STYLE OF LENSES, AND WE HAVE USED DIFFERENT INSTRUMENT SETS EACH TIME. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 2 OF 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2210264 CLAREON ASPHERIC HYDROPHOBIC ACRYLIC IOL INTRAOCULAR LENS HQL ALCON RESEARCH, LLC - HUNTINGTON SY60WF 15842928 00380652251440

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown MONARCH III IOL, CARTRIDGE D.