BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLAREON VIVITY TORIC EXTENDED VISION HYDROPHOBIC IOL

    MDR report key: 23803650 · Received December 15, 2025

    Report

    Report Number
    9612169-2025-02518
    Event Type
    Injury
    Date Received
    December 15, 2025
    Report Date
    April 13, 2026
    Manufacturer
    ALCON LABORATORIES IRELAND LTD.
    Product Code
    MJP
    UDI-DI
    00380652466080
    PMA / PMN Number
    P190018
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    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).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS PROVIDED IN H.3., H.6 AND H.11. THE PRODUCT WAS RETURNED FOR ANALYSIS. THE REPORTED COMPLAINT CANNOT BE CONFIRMED FROM THE RETURNED SAMPLE. INTRA OCULAR LENS (IOL) RETURNED POSITIONED INCORRECTLY IN THE IOL CASE. SIGNIFICANT AMOUNT OF SOLUTION IS DRIED ON THE IOL. THE OPTIC IS TORN OR SPLIT CUT DIVIDING THE IOL IN TWO, THE TWO IOL SEGMENTS ARE ADHERED TO EACH OTHER WITH SOLUTION. THE ROOT CAUSE FOR THE REPORTED COMPLAINT COULD NOT BE DETERMINED. BASED ON THE RESULTS FROM THE PRODUCT HISTORY RECORD, THE PRODUCTS MET RELEASE CRITERIA. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED AND STATED, THE LENS WAS REPLACED WITH OTHER COMPANY LENS.

    Description of Event or Problem · 0

    A HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED DISCOMFORT WITH VISUAL DISTURBANCES. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 01 MONTH 24 DAYS FOLLOWING THE INITIAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17379 CLAREON VIVITY TORIC EXTENDED VISION HYDROPHOBIC IOL LENS, INTRAOCULAR, TORIC OPTICS MJP ALCON LABORATORIES IRELAND LTD. CNWET2 25375531 00380652466080

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE C.