BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLAREON TORIC ASPHERIC HYDROPHOBIC ACRYLIC IOL WITH AUTONOME DELIVERY SYSTEM

    MDR report key: 21090887 · Received January 7, 2025

    Report

    Report Number
    9612169-2025-00045
    Event Type
    Malfunction
    Date Received
    January 7, 2025
    Date of Event
    December 13, 2024
    Report Date
    March 21, 2025
    Manufacturer
    ALCON LABORATORIES IRELAND LTD.
    Product Code
    MJP
    UDI-DI
    00380652398848
    PMA / PMN Number
    P190018
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS PROVIDED IN A.1., A.2., A.3.A., B.5., B.6., E.1., H.3., H.6 AND H.11. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. ONLY PHOTO AND VIDEO WAS RETURNED. THE REPORTER STATED: IT SEEMS THAT THE SURGEON HAS NOT BEEN ABLE TO KEEP CHECKING THE CONDITION OR IOL, SO IT IS UNCLEAR WHETHER THE FINDING IS CONTINUING OR HAVE DISAPPEARED. 9 PHOTOS RECEIVED. THE OPTIC APPEARS TO HAVE A CLOUDED APPEARANCE IN THE PHOTOS UNDER DIFFERENT LIGHT SETTINGS. LINES CAN BE SEEN AGAINST THE CLOUDED APPEARANCE, THERE IS ALSO A BLUE COLOUR IN SOME PHOTOS. THE VIDEO SHOWS IOL(INTRAOCULAR LENS) IMPLANTATION. AFTER THE IOL IS IMPLANTED, THE IOL IS MANIPULATED WITH A SURGICAL TOOL IN WHAT APPEARS TO BE AN ATTEMPT TO SHOW/VIEW THE REPORTED ISSUE. A SLIGHT CLOUDINESS/REFLECTION CAN BE SEEN ON THE OPTIC UNDER CERTAIN LIGHT CONDITIONS/LIGHT REFLECTIONS. THE ORIGIN OF THE REPORTED COMPLAINT CANNOT BE CONFIRMED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4). H.10 REFLECTS ALL RELATED REPORT NUMBERS ASSOCIATED WITH THIS PRODUCT EVENT THAT HAVE BEEN SUBMITTED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    CORRECTION INFORMATION WAS PROVIDED IN E.1. AND H.11. H.11- ON SUPPLEMENTAL REPORT#1, THE RECEIVED PHOTOS WERE MENTIONED AS NINE WHERE AS IT SHOULD BE EIGHT. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4). H.10 REFLECTS ALL RELATED REPORT NUMBERS ASSOCIATED WITH THIS PRODUCT EVENT THAT HAVE BEEN SUBMITTED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    A PRODUCT WAS NOT RETURNED FOR ANALYSIS; THE LENS REMAINS IMPLANTED. 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). H.10 REFLECTS ALL RELATED REPORT NUMBERS ASSOCIATED WITH THIS PRODUCT EVENT THAT HAVE BEEN SUBMITTED AT THIS TIME.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING PATIENT WAS EXPERIENCING POOR VISION, ALSO REPORTED THERE MIGHT BE POSSIBLE PATIENT HARM.

    Description of Event or Problem · 0

    A SURGEON REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SURGEON COULD SEE AN OIL LIKE FILM ON THE SURFACE OF IOLS. WHEN SURGEON TOUCHED THE IOL AFTER IMPLANTATION WITH A HOOK OR HYDRO NEEDLE, ONLY THE TOUCHED AREA SEEMS TO BE PEELED OFF. THE SURGEON COMMENTED THAT THIS IOL FINDING CLEARLY VISIBLE UNDER A MICROSCOPE BUT NOT SO MUCH ON VIDEO. THE SURGERY WAS PERFORMED AND COMPLETED WITHOUT PRODUCT REPLACEMENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TEN MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 7 OF 10.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    883337 CLAREON TORIC ASPHERIC HYDROPHOBIC ACRYLIC IOL WITH AUTONOME DELIVERY SYSTEM LENS, INTRAOCULAR, TORIC OPTICS MJP ALCON LABORATORIES IRELAND LTD. CNA0T3 25641133 00380652398848

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male