BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLAREON VIVITY EXTENDED VISION UV ABSORBING IOL

    MDR report key: 23957168 · Received January 5, 2026

    Report

    Report Number
    9612169-2026-00021
    Event Type
    Injury
    Date Received
    January 5, 2026
    Date of Event
    July 10, 2025
    Report Date
    April 6, 2026
    Manufacturer
    ALCON LABORATORIES IRELAND LTD.
    Product Code
    POE
    UDI-DI
    00380652405768
    PMA / PMN Number
    P190018
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    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. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS:(B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS PROVIDED IN D.9., H.3., H.6. AND H.11. THE PRODUCT WAS RETURNED FOR ANALYSIS. THE REPORTED COMPLAINT CANNOT BE CONFIRMED FROM THE RETURNED SAMPLE. INTRAOCULAR LENS (IOL) RECEIVED IN A PLASTIC CONTAINER INSIDE A PLASTIC BAG. A SIGNIFICANT AMOUNT OF SOLUTION IS DRIED ON THE IOL. ONE HAPTIC IS SLIGHTLY DEFORMED AND IMMOBILISED WITH DRIED UP SOLUTION BETWEEN THE HAPTIC ARM AND THE OPTIC. THE ROOT CAUSE FOR THE REPORTED COMPLAINT COULD NOT BE DETERMINED. BASED ON THE RESULTS FROM THE PRODUCT HISTORY RECORD, THE PRODUCTS MET RELEASE CRITERIA. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT WAS HAVING POOR VISION. CLINICAL REASON IS MALADAPTION. THE IOL WAS EXCHANGED FOR NON COMPANY MONOFOCAL INTRA OCULAR LENS 5 MONTHS 2 WEEKS 1 DAY FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION RECIEVED AND STATED THAT PATIENT WAS COMPLAINING ALL OVER HAZE AND POOR NEAR VISION SINCE DAY 1 POST OPERATION. THERE WAS NO PATIENT HARM. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS ASSOCIATED TO LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19840 CLAREON VIVITY EXTENDED VISION UV ABSORBING IOL EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS POE ALCON LABORATORIES IRELAND LTD. CCWET0 25318467 00380652405768

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Other| R MONARCH III IOL CARTRIDGE C.| PROVISC OVD.