BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVO/EVO+ VISIAN IMPLANTABLE COLLAMER LENS

    MDR report key: 25104887 · Received May 6, 2026

    Report

    Report Number
    2023826-2026-00778
    Event Type
    Injury
    Date Received
    May 6, 2026
    Date of Event
    April 29, 2026
    Report Date
    May 6, 2026
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    UDI-DI
    00840311300877
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION TYPE 4110: A LENS WORK ORDER SEARCH WAS PERFORMED. NO ADDITIONAL SIMILAR COMPLAINT TYPE EVENTS WITHIN ASSOCIATED LOTS WERE FOUND. H11-MANUFACTURER NARRATIVE: IRITIS IS AN INFLAMMATORY CONDITION WHICH IS COMMON AFTER INTRA-OCULAR SURGERY, HOWEVER THIS IS USUALLY MILD AND DOES NOT REQUIRE ANY ADDITIONAL INTERVENTIONS BEYOND THE STANDARD POST-OP REGIMEN. IN SOME CASES, THE DEGREE OF INFLAMMATION MAY BE MORE SEVERE AND REQUIRE EXTENDED STEROID TREATMENT. PROCEDURAL FACTORS INCLUDING EXCESSIVE SURGICAL MANIPULATION AND THE USE OF PRO-INFLAMMATORY SUBSTANCES IN THE EYE MAY HAVE CONTRIBUTED TO THE EVENT. MECHANICAL INSULT TO THE IRIS CAN RESULT IN A PROLONGED OR STRONGER INFLAMMATORY RESPONSE. AN EXACT CAUSE COULD NOT BE DETERMINED AS THE EVENT COULD BE MULTIFACTORIAL IN NATURE INCLUDING PATIENT AND/OR PROCEDURE RELATED FACTORS. 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 UVEITIS / IRITIS, SIGNIFICANT REDUCTION OF ENDOTHELIAL CELL COUNT AND MYDRIASIS. NO DIAGNOSTIC CULTURES WERE PERFORMED. TREATMENT WAS PERFORMED BUT PROBLEM WAS NOT RESOLVED. LENS REMAINS IMPLANTED. CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171555 EVO/EVO+ VISIAN IMPLANTABLE COLLAMER LENS PHAKIC INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY VICM5 13.2 (-7.00) 00840311300877

    Patients

    Seq Age Sex Outcome Treatment
    1