BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLAREON TORIC ASPHERIC HYDROPHOBIC ACRYLIC IOL WITH AUTONOME DELIVERY SYSTEM

    MDR report key: 23919629 · Received December 30, 2025

    Report

    Report Number
    9612169-2025-02620
    Event Type
    Injury
    Date Received
    December 30, 2025
    Date of Event
    December 8, 2025
    Report Date
    December 30, 2025
    Manufacturer
    ALCON LABORATORIES IRELAND LTD.
    Product Code
    MJP
    UDI-DI
    00380652398312
    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 (CNA0T3-T9) 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 AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT DEVELOPED ENDOPHTHALMITIS DUE TO LENS. MEDICAL TREATMENT TO THE PATIENT WAS IRRIGATION OF ANTERIOR CHAMBER AND VITREOUS. THE LENS REMAINS IMPLANTED IN THE PATIENT'S EYE. ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE PATIENT HAD DESCEMET¿S MEMBRANE FOLDS, TOXIC ANTERIOR SEGMENT SYNDROME (TASS), CONJUNCTIVAL HYPEREMIA, ABNORMAL FLARE VALUE (30 OR HIGHER), SEVERE INFLAMMATION AROUND THE IOL. NO IOL REPLACEMENT WAS PERFORMED INSTEAD WASHING OF THE ANTERIOR CHAMBER AND VITREOUS WAS CARRIED OUT. THE PATIENT WAS TREATED WITH BETAMETHASONE, CEFMENOXIME HYDROCHLORIDE, BROMFENAC, LEVOFLOXACIN, TEPRENONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1710920 CLAREON TORIC ASPHERIC HYDROPHOBIC ACRYLIC IOL WITH AUTONOME DELIVERY SYSTEM LENS, INTRAOCULAR, TORIC OPTICS MJP ALCON LABORATORIES IRELAND LTD. CNA0T2 25866838 00380652398312

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Other| R UNITY VCS CONSOLE