BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLAREON PANOPTIX TRIFOCAL HYDROPHOBIC INTRAOCULAR LENS

    MDR report key: 21445672 · Received February 24, 2025

    Report

    Report Number
    1119421-2025-00494
    Event Type
    Injury
    Date Received
    February 24, 2025
    Date of Event
    November 21, 2024
    Report Date
    February 24, 2025
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    MFK
    UDI-DI
    00380652408165
    PMA / PMN Number
    P190018
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, 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).

    Description of Event or Problem · 0

    A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, AFTER INTRAOCULAR LENS IMPLANTATION SURGERY, THE PATIENT CANNOT SEE TO DRIVE AT NIGHT BECAUSE THE HEADLIGHTS ALL LOOK LIKE FIREWORKS, HER CHRISTMAS TREE LOOKED LIKE FIREWORKS. ALL LIGHTS HAD A TERRIBLE GLARE OR HALO. ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING THAT THE PATIENT EXPERIENCED DECREASED VISION FROM GLARE AND HALOS, MORE SIGNIFICANTLY AT NIGHT WHILE DRIVING DUE TO WHICH SHE WAS UNABLE TO DRIVE. ADDITIONALLY, AN ALPHA-ADRENERGIC AGONIST DRUG HAS BEEN PRESCRIBED TO THE PATIENT TO CAUSE MIOSIS OF THE PUPIL. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING THAT, THE PATIENT'S SYMPTOMS WAS ONGOING. SHE WAS TOLD BY HER SURGEON THAT, HALOS AND GLARE ARE SIDE EFFECT OF THE LENS TECHNOLOGY, AND MOST PEOPLE CAN ADAPT OVER TIME. SHE HAS TRIED ALPHA-ADRENERGIC AGONIST DRUG FOR NIGHT DRIVING BUT HAD NO IMPROVEMENT. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404903 CLAREON PANOPTIX TRIFOCAL HYDROPHOBIC INTRAOCULAR LENS LENS, MULTIFOCAL INTRAOCULAR MFK ALCON RESEARCH, LLC - HUNTINGTON CNWTT0 15793401 00380652408165

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other| R MONARCH II LOADING FORCEPS| MONARCH III IOL, CARTRIDGE D| MONARCH III IOL, INJECTOR| PROVISC OPHTHALMIC VISCOSURGICAL DEVICE