BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLAREON PANOPTIX TORIC TRIFOCAL HYDROPHOBIC IOL W/AUTONOME DELIVERY SYSTEM

    MDR report key: 24466671 · Received February 27, 2026

    Report

    Report Number
    9612169-2026-00435
    Event Type
    Injury
    Date Received
    February 27, 2026
    Date of Event
    January 8, 2026
    Report Date
    May 21, 2026
    Manufacturer
    ALCON LABORATORIES IRELAND LTD.
    Product Code
    MJP
    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 RECORD COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A VALID LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. 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).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS PROVIDED IN H.3., H.6. AND H.11. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. ONLY PHOTO WAS RETURNED. THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION OF THE PRODUCT. PHOTO PROVIDED SHOWS AN INTRAOCULAR LENS (IOL) IN A PLASTIC CONTAINER. THE IOL APPEARS TO BE IN TWO SEGMENTS. THE ROOT CAUSE FOR THE REPORTED COMPLAINT COULD NOT BE DETERMINED. ALL PRODUCT HISTORY RECORDS ARE QUALITY REVIEWED PRIOR TO PRODUCT RELEASE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A HEALTH CARE PROFESSIONAL REPORTED THAT AFTER AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE PATIENT DID NOT ADAPT WELL TO THE LENS, AND THE LENS WAS EXPLANTED AND EXCHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235016 CLAREON PANOPTIX TORIC TRIFOCAL HYDROPHOBIC IOL W/AUTONOME DELIVERY SYSTEM LENS, INTRAOCULAR, TORIC OPTICS MJP ALCON LABORATORIES IRELAND LTD. CNATT2 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1