BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVO/EVO+VISIAN IMPLANTABLE COLLAMER LENS

    MDR report key: 22057644 · Received May 20, 2025

    Report

    Report Number
    2023826-2025-00722
    Event Type
    Injury
    Date Received
    May 20, 2025
    Report Date
    May 20, 2025
    Manufacturer
    STAAR SURGICAL
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER NARRATIVE: IOP ELEVATION FROM BASELINES IS IDENTIFIED IN THE LABELING AS A KNOWN POTENTIAL ADVERSE EVENT FOLLOWING ICL IMPLANTATION. CLAIM # (B)(4).

    Description of Event or Problem · 0

    A FACILITY REPRESENTATIVE REPORTED THAT AN IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S EYE. THE PATIENT EXPERIENCED PAIN AND ELEVATED INTRAOCULAR PRESSURE, AND SOME VAULTING. PIGMENT DISPERSION WAS ADDITIONALLY REPORTED AND THE PATIENT WAS PRESCRIBED IOP MEDICATION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    936944 EVO/EVO+VISIAN IMPLANTABLE COLLAMER LENS PHAKIC INTRAOCULAR LENS MTA STAAR SURGICAL N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention