BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLAREON VIVITY TORIC EXTENDED VISION HYDROPHOBIC IOL

    MDR report key: 25150918 · Received May 12, 2026

    Report

    Report Number
    1119421-2026-01036
    Event Type
    Malfunction
    Date Received
    May 12, 2026
    Date of Event
    April 15, 2026
    Report Date
    May 12, 2026
    Manufacturer
    ALCON LABORATORIES IRELAND LTD.
    Product Code
    MJP
    UDI-DI
    00380652466097
    PMA / PMN Number
    P190018
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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. 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).

    Description of Event or Problem · 0

    A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HAPTIC BROKE UPON ADVANCING THE LENS THROUGH THE CARTRIDGE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195546 CLAREON VIVITY TORIC EXTENDED VISION HYDROPHOBIC IOL LENS, INTRAOCULAR, TORIC OPTICS MJP ALCON LABORATORIES IRELAND LTD. CNWET2 25875493 00380652466097

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown