BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLAREON VIVITY EXTENDED VISION UV ABSORBING IOL

    MDR report key: 23310438 · Received October 16, 2025

    Report

    Report Number
    1119421-2025-02704
    Event Type
    Injury
    Date Received
    October 16, 2025
    Report Date
    October 16, 2025
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    POE
    UDI-DI
    00380652405768
    PMA / PMN Number
    P190018
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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 EXPERIENCED BLURRED DISTANCE VISION. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH ADVANCED TECHNOLOGY INTRAOCULAR LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS RESIDUAL REFRACTIVE ERROR ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2535392 CLAREON VIVITY EXTENDED VISION UV ABSORBING IOL EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS POE ALCON RESEARCH, LLC - HUNTINGTON CCWET0 15718138 00380652405768

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention