BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRA-OCULAR TORIC LENS

    MDR report key: 23357513 · Received October 22, 2025

    Report

    Report Number
    MW5177771
    Event Type
    Malfunction
    Date Received
    October 22, 2025
    Date of Event
    November 7, 2023
    Report Date
    October 21, 2025
    Manufacturer
    ALCON RESEARCH, LLC.
    Product Code
    KYB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PATIENT REPORTED SHE HAD A INTRA-OCULAR TORIC LENS SURGERY TO HER RIGHT EYE ON (B)(6) 2023 AND TO THE LEFT EYE (B)(6) 2023. PATIENT REPORTED SEVERE EYE PAIN AND FLICKERING. PATIENT HAS TO WEAR SUNGLASS ALL THE TIME BECAUSE LIGHTS HURTS EYES. PATIENT STATED THE DOCTOR SAID IT CAN BE FIXED BUT THERE'S A RISK I MIGHT GO BLIND. PT CODES: 4467, 4801, 2138. DEVICE CODE: 4001. REF REPORT: MW5177772.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2730424 INTRA-OCULAR TORIC LENS LENS, GUIDE, INTRAOCULAR KYB ALCON RESEARCH, LLC. 25442645133

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Other