BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVO/EVO+VISIAN IMPLANTABLE COLLAMER LENS

    MDR report key: 23498435 · Received November 7, 2025

    Report

    Report Number
    2023826-2025-01739
    Event Type
    Injury
    Date Received
    November 7, 2025
    Date of Event
    June 21, 2025
    Report Date
    November 7, 2025
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    QCB
    UDI-DI
    00840311308521
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3 - DEVICE EVALUATION IS NOT REQUIRED. H6 - TYPE OF INVESTIGATION: 4110 - LENS WORK ORDER SEARCH: NO SIMILAR COMPLAINT TYPE EVENTS REPORTED FOR UNITS WITHIN THE SAME LOT. MANUFACTURE NARRATIVE: SECONDARY SURGICAL INTERVENTION TO REMOVE/REPLACE/REPOSITION THE LENS 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 FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE THE PATIENT EXPERIENCED BLURRED VISION AND THE PATIENT DISSATISFACTION WITH VISION. THE LENS EXPLANTED AND THE PROBLEM RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN AND PATIENT RELATED FACTOR, "ARK MEASURED AFTER LENS REMOVAL: -1.0/-3.75/175."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174155 EVO/EVO+VISIAN IMPLANTABLE COLLAMER LENS PHAKIC TORIC INTRAOCULAR LENS QCB STAAR SURGICAL COMPANY VTICM5 12.6 (-3.00/2.5) N/A 00840311308521

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Female Required Intervention