BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLAREON VIVITY TORIC EXTENDED VISION HYDROPHOBIC IOL W/AUTONOME DELIVERY SYSTEM

    MDR report key: 24774411 · Received April 3, 2026

    Report

    Report Number
    9612169-2026-00737
    Event Type
    Malfunction
    Date Received
    April 3, 2026
    Date of Event
    March 5, 2026
    Report Date
    April 3, 2026
    Manufacturer
    ALCON LABORATORIES IRELAND LTD.
    Product Code
    MJP
    UDI-DI
    00380652459419
    PMA / PMN Number
    P190018
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 (CNAET3-T6) THAT IS SOLD IN THE UNITED STATES UNDER (PMA/510(K) # (P190018). 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).

    Description of Event or Problem · 0

    A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE TRAILING HAPTIC FOLDED WRONG. ADDITIONAL INFORMATION HAS BEEN REQUESTED, YET NO NEW INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838411 CLAREON VIVITY TORIC EXTENDED VISION HYDROPHOBIC IOL W/AUTONOME DELIVERY SYSTEM LENS, INTRAOCULAR, TORIC OPTICS MJP ALCON LABORATORIES IRELAND LTD. CNAET2 26068016 00380652459419

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male CURAGEL HYPROMELLOSE OVD 2% W/V 2 ML PFS