BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLAREON PANOPTIX TORIC TRIFOCAL HYDROPHOBIC IOL

    MDR report key: 21477510 · Received February 27, 2025

    Report

    Report Number
    9612169-2025-00288
    Event Type
    Injury
    Date Received
    February 27, 2025
    Date of Event
    November 23, 2024
    Report Date
    February 27, 2025
    Manufacturer
    ALCON LABORATORIES IRELAND LTD.
    Product Code
    MJP
    PMA / PMN Number
    P190018
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT EXPERIENCED SYMPTOMATIC GLARE AND HALOS. IT DID NOT IMPROVE WITH SURFACE TREATMENT WITH ALL AVENUES HAD BEEN EXHAUSTED. THE LENS WAS EXCHANGED FOR AN UNKNOWN ADVANCED TECHNOLOGY INTRAOCULAR LENS (ATIOL) AFTER THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION RECEIVED STATING THAT PATIENT EXPERIENCED GLARE AND RINGS AROUND LIGHTS AND PATIENT ISSUE NEVER IMPROVED FOLLOWING OPERATION. IN THE SURGEON¿S OPINION PATIENT DID NOT TOLERATE SYMPTOMS OF A MULTIFOCAL IOL. THE LENS WAS EXCHANGED WITH COMPANY IOL WITH SAME MODEL AND DIFFERENT DIOPTER FOLLOWING THE INITIAL IMPLANT PROCEDURE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS FILE IS FOR LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594699 CLAREON PANOPTIX TORIC TRIFOCAL HYDROPHOBIC IOL LENS, INTRAOCULAR, TORIC OPTICS MJP ALCON LABORATORIES IRELAND LTD. CNWTT3 25366055

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Required Intervention CLAREON MONARCH IV INJECTOR| CLAREON TORIC IOL| DUOVISC VISCOELASTIC SYSTEM| MONARCH II LOADING FORCEPS| MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D