BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLAREON VIVITY TORIC EXTENDED VISION HYDROPHOBIC IOL

    MDR report key: 21592242 · Received March 13, 2025

    Report

    Report Number
    1119421-2025-00663
    Event Type
    Malfunction
    Date Received
    March 13, 2025
    Date of Event
    February 13, 2025
    Report Date
    March 13, 2025
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    MJP
    UDI-DI
    00380652466462
    PMA / PMN Number
    P190018
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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).

    Description of Event or Problem · 0

    A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, AFTER THE LENS WAS IMPLANTED IN THE EYE, IT WAS NOTICED THE LENS HAD A HUGE CRACK OR SCRATCH ACROSS THE CENTER, SURGEON STATED THAT HE DOES NOT KNOW IF THIS WAS AN ISSUE WITH THE TECH WHO LOADED THE LENS OR IT WAS A MANUFACTURER DEFECT. THE LENS WAS INSERTED INTO THE EYE AND HAD TO BE EXTRACTED AND REPLACED DURING INITIAL PROCEDURE. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    991227 CLAREON VIVITY TORIC EXTENDED VISION HYDROPHOBIC IOL LENS, INTRAOCULAR, TORIC OPTICS MJP ALCON RESEARCH, LLC - HUNTINGTON CNWET3 15571094 00380652466462

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown