BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLAREON PANOPTIX TORIC TRIFOCAL HYDROPHOBIC IOL

    MDR report key: 25148428 · Received May 12, 2026

    Report

    Report Number
    1119421-2026-01033
    Event Type
    Malfunction
    Date Received
    May 12, 2026
    Date of Event
    April 15, 2026
    Report Date
    May 12, 2026
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    MJP
    UDI-DI
    00380652467803
    PMA / PMN Number
    P190018
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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 (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 DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HAPTIC WAS FOUND BROKEN DURING LENS IMPLANTATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83150 CLAREON PANOPTIX TORIC TRIFOCAL HYDROPHOBIC IOL LENS, INTRAOCULAR, TORIC OPTICS MJP ALCON RESEARCH, LLC - HUNTINGTON CNWTT2 15885736 00380652467803

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown CLAREON MONARCH IV IOL DELIVERY SYSTEM, INJECTOR| MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D| PROVISC OPHTHALMIC VISCOSURGICAL DEVICE