BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLAREON TORIC IOL

    MDR report key: 25128312 · Received May 8, 2026

    Report

    Report Number
    1119421-2026-01012
    Event Type
    Injury
    Date Received
    May 8, 2026
    Date of Event
    April 14, 2026
    Report Date
    May 8, 2026
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    MJP
    UDI-DI
    00380652409711
    PMA / PMN Number
    P190018
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE 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 NON-HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED VISION STILL BLURRY. SUBSEQUENTLY THE LENS WAS REMOVED AND REPLACED WITH AN UNSPECIFIED ADVANCED TECHNOLOGY INTRAOCULAR LENS (ATIOL) IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS MECHANICAL FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320814 CLAREON TORIC IOL LENS, INTRAOCULAR, TORIC OPTICS MJP ALCON RESEARCH, LLC - HUNTINGTON CNW0T3 15908689 00380652409711

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention