BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLAREON VIVITY TORIC EXTENDED VISION HYDROPHOBIC IOL

    MDR report key: 24723207 · Received March 30, 2026

    Report

    Report Number
    1119421-2026-00632
    Event Type
    Injury
    Date Received
    March 30, 2026
    Date of Event
    February 25, 2026
    Report Date
    March 27, 2026
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    MJP
    UDI-DI
    00380652466141
    PMA / PMN Number
    P190018
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW AND A NON-CONFORMANCE REVIEW OF THE REPORTED LOT NUMBER WAS CONDUCTED. THE DEVIATION REVIEW DID NOT REVEAL ANY POTENTIAL CONTRIBUTING FACTORS TO THE REPORTED COMPLAINT AND ALL CORRESPONDING PRODUCTION RELEASE SPECIFICATIONS DEFINED IN THE DEVICE MASTER RECORD WERE MET. 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

    THE SURGEON REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS LOADED ACCORDING TO THE INSTRUCTIONS WITHOUT ANY CHALLENGES. WHEN THE LENS WAS INSERTED INTO THE EYE, TWO LARGE SCRATCHES WERE NOTICED ON BOTH SIDES OF THE LENS. AS THE LENS HAD ALREADY BEEN PLACED IN THE PATIENT¿S EYE, THE SURGEON HAD TO WIDEN THE TUNNEL IN ORDER TO CUT THE LENS INTO PIECES AND REMOVE IT FROM THE EYE, WHICH CAUSED ADDITIONAL STRAIN ON THE EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787111 CLAREON VIVITY TORIC EXTENDED VISION HYDROPHOBIC IOL LENS, INTRAOCULAR, TORIC OPTICS MJP ALCON RESEARCH, LLC - HUNTINGTON CNWET2 15952475 00380652466141

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention