BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLAREON TORIC IOL

    MDR report key: 22806714 · Received August 14, 2025

    Report

    Report Number
    9612169-2025-01658
    Event Type
    Injury
    Date Received
    August 14, 2025
    Date of Event
    July 22, 2025
    Report Date
    August 14, 2025
    Manufacturer
    ALCON LABORATORIES IRELAND LTD.
    Product Code
    MJP
    UDI-DI
    00380652409223
    PMA / PMN Number
    P190018
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    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. 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 (CNW0T3-T9) 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 OTHER HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED STRIPED LENS ON OPTICS. THE PROCEDURE WAS COMPLETED ON SUBSEQUENT DAY. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1556675 CLAREON TORIC IOL LENS, INTRAOCULAR, TORIC OPTICS MJP ALCON LABORATORIES IRELAND LTD. CNW0T2 25876260 00380652409223

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention CLAREON MONARCH IV IOL DELIVERY SYSTEM, INJECTOR.| MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE C.| UNSPECIFIED OPHTHALMIC VISCOSURGICAL DEVICE.