BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLAREON PANOPTIX TORIC TRIFOCAL HYDROPHOBIC IOL

    MDR report key: 22575915 · Received July 23, 2025

    Report

    Report Number
    9612169-2025-01451
    Event Type
    Injury
    Date Received
    July 23, 2025
    Date of Event
    October 25, 2024
    Report Date
    July 23, 2025
    Manufacturer
    ALCON LABORATORIES IRELAND LTD.
    Product Code
    MJP
    UDI-DI
    00380652468077
    PMA / PMN Number
    P190018
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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 (CNWTT3-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 FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT EXPERIENCED GLARE AT NIGHT AND HE WAS UNABLE TO DRIVE AT NIGHT. PATIENT DOES NOT WANT RIGHT EYE OPERATED UNTIL HE WAS HAPPY WITH LEFT EYE. SURGEON PLANNED TO COMPLETE A LENS EXCHANGE. ADDITIONAL INFORMATION WAS RECEIVED AND STATED, LASER CAPSULOTOMY PERFORMED ON THE (B)(6) 2025. IOL EXCHANGE WAS SCHEDULED AND NOT YET COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2036956 CLAREON PANOPTIX TORIC TRIFOCAL HYDROPHOBIC IOL LENS, INTRAOCULAR, TORIC OPTICS MJP ALCON LABORATORIES IRELAND LTD. CNWTT2 25388016 00380652468077

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other| R CLAREON MONARCH IV IOL DELIVERY SYSTEM, INJECTOR| UNSPECIFIED CARTRIDGE