BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLAREON PANOPTIX TORIC TRIFOCAL HYDROPHOBIC IOL

    MDR report key: 16972316 · Received May 22, 2023

    Report

    Report Number
    9612169-2023-00377
    Event Type
    Injury
    Date Received
    May 22, 2023
    Date of Event
    October 13, 2022
    Report Date
    November 8, 2023
    Manufacturer
    ALCON LABORATORIES IRELAND LTD.
    Product Code
    MJP
    UDI-DI
    00380652469609
    PMA / PMN Number
    P190018
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    A SAMPLE DEVICE 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

    THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED THAT PATIENT HAD MULTIPLE CONSULTATIONS THAT CONFIRMED THAT THE LENSES WERE PLACED PROPERLY IN MY EYES. THE PATIENT FEELS THAT THE LENS DID NOT IMPROVE THE VISION SPECIALLY ASTIGMATISM. THE PATIENT FELT EXTREMELY UNCOMFORTABLE IN THE EYE AND HAD CONSTANT TEARING, DRY, ITCHY AND PAIN IN EYE ALSO SEE FLASHES OF PRISM LIGHT. THE PATIENT WAS NOT HAPPY WITH THE LENS. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

    Description of Event or Problem · 0

    A NON HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT COULDN'T SEE WELL AT ANY DISTANCE AND EYES DID NOT HEAL AS WELL AS EXPECTED. THE PATIENT ALSO HAD A YTTRIUM ALUMINUM GARNET (YAG) OD. PATIENT POST OPERATIVE VISION WAS 20/50. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT THE PATIENT EYESIGHT WAS WORSE THAN BEFORE AND WAS NOT ABLE TO SEE WELL AT ANY FOCAL LENGTH. PATIENT USING THREE PAIR OF EYEGLASSES TO FUNCTION IN EVERYDAY LIFE. THE SURGEON WHO OPERATED PERFORMED TWO YAG PROCEDURES TO IMPROVE THE OUTCOME. THE SUBSEQUENT CONSULTATIONS DETERMINED THAT THE COMPANY MODEL LENS WAS INAPPROPRIATE FOR THE EYES AND INDICATED TO REMOVE THE LENS BUT AFTER YAG THAT WAS NO LONGER A POSSIBLE OPTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478369 CLAREON PANOPTIX TORIC TRIFOCAL HYDROPHOBIC IOL LENS, INTRAOCULAR, TORIC OPTICS MJP ALCON LABORATORIES IRELAND LTD. CNWTT5 25357254 00380652469609

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention