BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLAREON PANOPTIX TORIC TRIFOCAL HYDROPHOBIC IOL

    MDR report key: 25001347 · Received April 27, 2026

    Report

    Report Number
    9612169-2026-00981
    Event Type
    Injury
    Date Received
    April 27, 2026
    Report Date
    April 27, 2026
    Manufacturer
    ALCON LABORATORIES IRELAND LTD.
    Product Code
    MJP
    UDI-DI
    00380652467957
    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

    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 ((B)(4))(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 NON-HEALTHCARE PROFESSIONAL STATED THAT IOL WAS EXCHANGED DUE TO DECREASED VISUAL ACUITY IN THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    206094 CLAREON PANOPTIX TORIC TRIFOCAL HYDROPHOBIC IOL LENS, INTRAOCULAR, TORIC OPTICS MJP ALCON LABORATORIES IRELAND LTD. CNWTT2 25366120 00380652467957

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention