BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVO/EVO + VISIAN IMPLANTABLE COLLAMER LENS (ICL)

    MDR report key: 24288304 · Received February 8, 2026

    Report

    Report Number
    2023826-2026-00213
    Event Type
    Injury
    Date Received
    February 8, 2026
    Date of Event
    January 27, 2026
    Report Date
    February 8, 2026
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    UDI-DI
    00840311300907
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6- INVESTIGATION TYPE CODE: 4110- LENS WORK ORDER SEARCH-NO SIMILAR COMPLAINT EVENT(S) WITHIN ASSOCIATED LOTS WERE FOUND. H11- MANUFACTURER NARRATIVE: IOP ELEVATION FROM BASELINE IS IDENTIFIED IN THE LABELING AS A KNOWN POTENTIAL ADVERSE EVENT FOLLOWING ICL IMPLANTATION. CLAIM# (B)(4).

    Additional Manufacturer Narrative · 0

    B5.- A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED ELEVATED IOP. MEDICATION WAS PRESCRIBED. IRRIGATION/ ASPIRATION WAS PERFORMED. THE LENS REMAINS IMPLANTED. REPORTEDLY, 'DAY AFTER THE SURGERY EVERYTHING WAS FINE' AND 'WE DO NOT PLAN EXPLANTATION OF THE LENS. IT WAS ONLY TEMPORARY ELEVATION OF THE IOP.' THE CAUSE OF THE EVENT WAS REPORTED AS OTHER- 'PROBABLY OVD' H6. HEALTH EFFECT- IMPACT CODE (F): 4625- IRRIGATION/ ASPIRATION WAS PERFORMED. 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 ELEVATED IOP. MEDICATION WAS PRESCRIBED. THE LENS REMAINS IMPLANTED. REPORTEDLY, 'DAY AFTER THE SURGERY EVERYTHING WAS FINE' AND 'WE DO NOT PLAN EXPLANTATION OF THE LENS. IT WAS ONLY TEMPORARY ELEVATION OF THE IOP.' THE CAUSE OF THE EVENT WAS REPORTED AS OTHER- 'PROBABLY OVD'.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383784 EVO/EVO + VISIAN IMPLANTABLE COLLAMER LENS (ICL) PHAKIC INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY VICM5 13.2 (-8.5) N/A 00840311300907

    Patients

    Seq Age Sex Outcome Treatment
    1