BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLAREON VIVITY TORIC EXTENDED VISION HYDROPHOBIC IOL

    MDR report key: 21983031 · Received May 8, 2025

    Report

    Report Number
    1119421-2025-01320
    Event Type
    Injury
    Date Received
    May 8, 2025
    Report Date
    May 8, 2025
    Manufacturer
    ALCON LABORATORIES IRELAND LTD.
    Product Code
    MJP
    UDI-DI
    00380652466103
    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

    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

    A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SURGEON IMPLANTED COMPANY LENS INTO A PATIENT AND ONE WEEK POST OFF IMPLANTED ANOTHER COMPANY LENS IN SECOND EYE. JUST A LITTLE OVER ONE WEEK POST OF FROM FIRST IMPLANTATION PATIENT STARTED TO EXPERIENCE CYSTOID MACULAR EDEMA, THEN SAME THING HAPPENED WITH SECOND EYE. REGULAR POST OPERATIVE DROPS WAS NOT WORKING SO SURGEON REFERRED TO RETINAL SURGEON FOR INTRAVITREAL INJECTION (IVT) TREATMENT. SURGEON SAID NOTHING NOTEWORTHY, SURGERY WAS COMPLETED AS PER NORMAL. ADDITIONAL INFORMATION WAS RECEIVED AND STATED, ISSUES STARTED 3 WEEKS AFTER IMPLANTATION. THE LENS STILL REMAINS IN THE PATIENT EYE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1035789 CLAREON VIVITY TORIC EXTENDED VISION HYDROPHOBIC IOL LENS, INTRAOCULAR, TORIC OPTICS MJP ALCON LABORATORIES IRELAND LTD. CNWET2 25805148 00380652466103

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| R CLAREON MONARCH IV INJECTOR| MONARCH III CARTRIDGE D| PROVISC