BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLAREON VIVITY TORIC EXTENDED VISION HYDROPHOBIC IOL

    MDR report key: 23208125 · Received October 3, 2025

    Report

    Report Number
    1119421-2025-02624
    Event Type
    Injury
    Date Received
    October 3, 2025
    Date of Event
    October 29, 2024
    Report Date
    November 24, 2025
    Manufacturer
    ALCON LABORATORIES IRELAND LTD.
    Product Code
    MJP
    PMA / PMN Number
    P190018
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS PROVIDED IN B.2., B.5., D.6B., AND H.6. 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 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. THIS PRODUCT IS NOT APPROVED OR INTRODUCED INTO COMMERCIAL DISTRIBUTION IN THE UNITED STATES. HOWEVER, THIS MEDWATCH IS BEING FILED BASED ON A SIMILAR PRODUCT (CNWET3-T6) THAT IS SOLD IN THE UNITED STATES UNDER (PMA/510(K) # (P190018). 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

    ADDITIONAL INFORMATION WAS RECEIVED STATING INTRA OCULAR LENS (IOL) WAS EXPLANTED AND REPLACED WITH ANOTHER LENS.

    Description of Event or Problem · 0

    A HEALTH CARE PROFESSIONAL REPORTED THAT AFTER AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT COMPLAINED ABOUT DIFFICULTY NIGHT DRIVING AND WANTS A LENS EXCHANGE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318429 CLAREON VIVITY TORIC EXTENDED VISION HYDROPHOBIC IOL LENS, INTRAOCULAR, TORIC OPTICS MJP ALCON LABORATORIES IRELAND LTD. CNWET2 25812854

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Male Other| R CLAREON MONARCH IV IOL DELIVERY SYSTEM, INJECTOR.| MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D.