BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLAREON VIVITY EXTENDED VISION UV ABSORBING IOL W/AUTONOME DELIVERY SYSTEM

    MDR report key: 24469982 · Received February 27, 2026

    Report

    Report Number
    9612169-2026-00445
    Event Type
    Injury
    Date Received
    February 27, 2026
    Report Date
    February 27, 2026
    Manufacturer
    ALCON LABORATORIES IRELAND LTD.
    Product Code
    POE
    UDI-DI
    00380652406819
    PMA / PMN Number
    P190018
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, 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-HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING THE INTRAOCULAR LENS (IOL) THE PATIENT EXPERIENCED POOR QUALITY OF VISION AND DOUBLE VISION. CLINICAL REASON MENTIONED WAS DECREASED CONTRAST, UPDATE IN REFRACTION NOT BENEFICIAL. ADDITIONAL INFORMATION RECEIVED AND STATED THAT THE PATIENT EXPERIENCED GLARE, STROBE LIGHTS AND UNCLEAR VISION. THE INTRAOCULAR LENS (IOL) EXCHANGE HAS BEEN PERFORMED DUE TO PATIENT¿S DISSATISFACTION. THE EXCHANGE WAS PERFORMED BY ANOTHER SURGEON. THERE WAS NO FURTHER IMPACT TO THE PATIENT. THE PATIENT ISSUE HAD BEEN RESOLVED POST IOL EXCHANGE. THE SURGEON¿S PROGNOSIS WAS EXCELLENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533216 CLAREON VIVITY EXTENDED VISION UV ABSORBING IOL W/AUTONOME DELIVERY SYSTEM EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS POE ALCON LABORATORIES IRELAND LTD. CCAET0 25835144 00380652406819

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention CLAREON MONARCH IV IOL DELIVERY SYSTEM, INJECTOR.| DUOVISC VISCOELASTIC SYSTEM.| LI61AO 20.0.| MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE C.