BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLAREON TORIC IOL

    MDR report key: 22046256 · Received May 19, 2025

    Report

    Report Number
    9612169-2025-01077
    Event Type
    Injury
    Date Received
    May 19, 2025
    Date of Event
    April 24, 2025
    Report Date
    August 29, 2025
    Manufacturer
    ALCON LABORATORIES IRELAND LTD.
    Product Code
    MJP
    UDI-DI
    00380652409186
    PMA / PMN Number
    P190018
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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 (CNW0T3-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 HAS BEEN 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. IOL RECEIVED WRAPPED IN A SURGICAL GAUZE INSIDE A DIFFERENT MANUFACTURER PRODUCT CARTON. SOLUTION IS DRIED ON THE IOL (INTRAOCULAR LENS). THERE ARE FIBERS ON BOTH HAPTICS AND THE OPTIC. THE OPTIC IS TORN/SPLIT-CUT DIVIDING THE IOL IN TWO. 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 PHYSICIAN REPORTED THAT AFTER INTRAOCULAR LENS IMPLANTATION SURGERY, ON THE RIGHT EYE, THE PATIENT EXPERIENCED DIZZINESS, DECREASED VISION AND BLURRING OF LIGHT. SO, THE LENS WAS REPLACED WITH NON COMPANY LENS IN THE SECONDARY IMPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164557 CLAREON TORIC IOL LENS, INTRAOCULAR, TORIC OPTICS MJP ALCON LABORATORIES IRELAND LTD. CNW0T2 25836274 00380652409186

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention