BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLAREON VIVITY EXTENDED VISION HYDROPHOBIC IOL

    MDR report key: 24662403 · Received March 23, 2026

    Report

    Report Number
    9612169-2026-00637
    Event Type
    Injury
    Date Received
    March 23, 2026
    Report Date
    March 23, 2026
    Manufacturer
    ALCON LABORATORIES IRELAND LTD.
    Product Code
    POE
    UDI-DI
    00380652405263
    PMA / PMN Number
    P190018
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    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 NURSE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRED VISION. CLINICAL REASON FOR EXPLANT REFRACTIVE SURPRISE. THE IOL WAS EXCHANGED FOR ADVANCED TECHNOLOGY INTRAOCULAR LENSES (ATIOL) MODEL LENS 13 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722442 CLAREON VIVITY EXTENDED VISION HYDROPHOBIC IOL EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS POE ALCON LABORATORIES IRELAND LTD. CNWET0 26067811 00380652405263

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention