BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLAREON TORIC ASPHERIC HYDROPHOBIC ACRYLIC IOL WITH AUTONOME DELIVERY SYSTEM

    MDR report key: 24844734 · Received April 10, 2026

    Report

    Report Number
    9612169-2026-00820
    Event Type
    Injury
    Date Received
    April 10, 2026
    Report Date
    May 18, 2026
    Manufacturer
    ALCON LABORATORIES IRELAND LTD.
    Product Code
    MJP
    UDI-DI
    00380652398282
    PMA / PMN Number
    P190018
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    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 CNA0T3-T9 THAT IS SOLD IN THE UNITED STATES UNDER (PMA/510(K) # (P190018). THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS PROVIDED IN B.5. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS FAULTY AND LENS WAS EXPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING NO OTHER INFORMATION TO PROVIDE ALL AVAILABLE INFORMATION WAS GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119340 CLAREON TORIC ASPHERIC HYDROPHOBIC ACRYLIC IOL WITH AUTONOME DELIVERY SYSTEM LENS, INTRAOCULAR, TORIC OPTICS MJP ALCON LABORATORIES IRELAND LTD. CNA0T2 26007640 00380652398282

    Patients

    Seq Age Sex Outcome Treatment
    1