BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVO/EVO+ VISIAN IMPLANTABLE COLLAMER LENS

    MDR report key: 24157568 · Received January 22, 2026

    Report

    Report Number
    2023826-2026-00043
    Event Type
    Injury
    Date Received
    January 22, 2026
    Report Date
    January 22, 2026
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    UDI-DI
    00840311300556
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: A REASSESSMENT WAS COMPLETED AND IT HAS BEEN DETERMINED THAT THE INITIAL MDR IS NOT APPLICABLE. THE PATIENT DID NOT EXPERIENCE A SERIOUS ADVERSE EVENT. CLAIM# (B)(4).

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION TYPE 4110: LENS WORK ORDER SEARCH- ONE SIMILAR COMPLAINT EVENT(S) WITHIN ASSOCIATED LOTS WERE FOUND. THE SIMILAR COMPLAINT IS RELATED TO THE FELLOW EYE LENS. 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 LOW VAULT AND ELEVATED IOP. IOP MEDICATION WAS ADMINISTERED. THE LENS REMAINS IMPLANTED. NO FURTHER INFORMATION HAS BEEN PROVIDED. THIS REPORT IS 1 OF 4 TOTAL REPORTS. BASED ON THE INFORMATION PROVIDED, THE RISK ASSESSMENT FOR OUR PRODUCT, AND OUR EXPERIENCE, WE HAVE DETERMINED THE CAUSE OR CONTRIBUTION TO THE REPORTED ISSUE IS NOT INDICATIVE OF A MANUFACTURING RELATED ISSUE OR PRODUCT DEFICIENCY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218919 EVO/EVO+ VISIAN IMPLANTABLE COLLAMER LENS PHAKIC INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY VICM5_12.6 -07.50 NA 00840311300556

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other