BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVO/EVO+VISIAN IMPLANTABLE COLLAMER LENS

    MDR report key: 23100888 · Received September 19, 2025

    Report

    Report Number
    2023826-2025-01360
    Event Type
    Injury
    Date Received
    September 19, 2025
    Date of Event
    August 20, 2025
    Report Date
    October 29, 2025
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    UDI-DI
    00840311302314
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: WORK ORDER SEARCH: NO SIMILAR COMPLAINTS WITHIN ASSOCIATED LOTS WERE FOUND. 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. -TOXIC ANTERIOR SEGMENT SYNDROME (TASS) IS AN ACUTE STERILE POSTOPERATIVE INFLAMMATION THAT CAN OCCUR AFTER UNCOMPLICATED OR COMPLICATED INTRAOCULAR SURGERY. WHILE IMPROPER STERILIZATION AND CONTAMINATION OF SURGICAL INSTRUMENTS REMAINS THE MOST COMMON RISK FACTOR ASSOCIATED WITH TASS, OCULAR VISCOELASTIC, AND IMPROPER PREPARATION OF ANTIBIOTICS FOR INTRACAMERAL INJECTION MAY ALSO LEAD TO TASS. AN EXACT CAUSE COULD NOT BE DETERMINED AS THE EVENT COULD BE MULTIFACTORIAL IN NATURE INCLUDING PATIENT AND/OR PROCEDURE RELATED FACTORS. (B)(4).

    Additional Manufacturer Narrative · 0

    H6: 3331 - DEVICE HISTORY RECORD REVIEW INDICATES THAT THE PRODUCT HAS BEEN MANUFACTURED WITHIN THE ESTABLISHED PROCESS PARAMETERS AND THAT THERE IS NO INDICATION THAT THE MANUFACTURING AND/OR PROCESSING OF THE DEVICE CONTRIBUTED TO THE COMPLAINT ISSUE. 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 TOXIC ANTERIOR SEGMENT SYNDROME AND UVEITIS/IRITIS. DIAGNOSTIC AND TREATMENT WERE PERFORMED. A BACTERIAL AND CANDIDAL CULTURE FOUND THE RESULTS AS NEGATIVE. MEDICATION WAS ADMINISTERED, BUT NOT BEYOND THE STANDARD POST-OPERATIVE TREATMENT PROTOCOL. REPORTEDLY, "OCULAR SWELLING AND PAIN OCCURRED 44 HOURS AFTER ICL SURGERY, DECREASED AT 54 HOURS, AND CILIARY HYPEREMIA, CORNEAL EDEMA, DUSTY KP ON THE POSTERIOR SURFACE WERE VISIBLE AT 60 HOURS AFTER ADMISSION TO THE HOSPITAL. LOCAL ANTI-INFECTIVE AND ANTI-INFLAMMATORY TREATMENT SLIGHTLY IMPROVED THE ABOVE PHENOMENA. THREE DAYS AFTER SURGERY, THE LENS WAS SURGICALLY REMOVED, THE ANTERIOR CHAMBER WAS IRRIGATED WITH ANTIBIOTICS, AND THE VITREOUS CAVITY WAS INJECTED. FIVE DAYS AFTER SURGERY, THE VITREOUS CAVITY WAS INJECTED AGAIN." THE PROBLEM WAS RESOLVED. CAUSE OF THE EVENT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1696809 EVO/EVO+VISIAN IMPLANTABLE COLLAMER LENS PHAKIC INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY VICMO_13.2(-5.0) N/A 00840311302314

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Male Other UNKNOWN.