BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLAREON PANOPTIX TORIC TRIFOCAL HYDROPHOBIC IOL W/AUTONOME DELIVERY SYSTEM

    MDR report key: 23403398 · Received October 28, 2025

    Report

    Report Number
    9612169-2025-02161
    Event Type
    Injury
    Date Received
    October 28, 2025
    Date of Event
    October 3, 2025
    Report Date
    October 28, 2025
    Manufacturer
    ALCON LABORATORIES IRELAND LTD.
    Product Code
    MJP
    UDI-DI
    00380652450294
    PMA / PMN Number
    P190018
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 (CNATT3-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 PHYSICIAN REPORTED THAT FOLLOWING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, ON (B)(6) 2025 THE PATIENT VISITED THE HOSPITAL WITH A FEELING OF PRESSING PAIN AND THE VISUAL ACUITY WAS 0.8. ON (B)(6) 2025, AFTER TAKING AN INTERNAL MEDICINE, THE PAIN SUBSIDED, BUT THE PATIENT REPORTED A GRITTY SENSATION AND BLURRED VISION. THE VISUAL ACUITY DECREASED FROM 0.8 TO 0.3. PATIENT MAY BE USING EYE DROPS. THERE WAS NO PLAN FOR REMOVAL AND PATIENT WAS UNDER OBSERVATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED, STATING THAT ON (B)(6) 2025 PRESSURE-LIKE EYE PAIN STARTED AROUND 2:30 AM. PATIENT TREATED WITH CORTICOSTEROIDS 15 MG. ON (B)(6) 2025 PAIN WAS NOT RELIEVED BY ORAL MEDICATION. PATIENT FEELS FOREIGN BODY SENSATION. PATIENT ADMINISTERED ORAL STEROIDS. EYE DROPS MAY ALSO BE ADMINISTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1550976 CLAREON PANOPTIX TORIC TRIFOCAL HYDROPHOBIC IOL W/AUTONOME DELIVERY SYSTEM LENS, INTRAOCULAR, TORIC OPTICS MJP ALCON LABORATORIES IRELAND LTD. CNATT2 25784360 00380652450294

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Required Intervention