BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVO VISIAN ICL

    MDR report key: 24429347 · Received February 23, 2026

    Report

    Report Number
    MW5184305
    Event Type
    Injury
    Date Received
    February 23, 2026
    Date of Event
    December 6, 2024
    Report Date
    February 19, 2026
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    QCB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    FOLLOWING IMPLANTABLE COLLAMER LENS (ICL) SURGERY IN BOTH EYES APPROXIMATELY ONE YEAR AGO, I HAVE EXPERIENCED THE FOLLOWING PERSISTENT ADVERSE EFFECTS. ALL SYMPTOMS BEGAN IMMEDIATELY AFTER THE PROCEDURE AND HAVE NOT IMPROVED OVER TIME DESPITE SEEKING TREATMENT. SEVERE GHOSTING IN MY LEFT EYE, PRESENT EVEN IN NORMAL LIGHTING CONDITIONS. GHOSTING IN MY RIGHT EYE IN DIM LIGHT. SEVERE GLARE SENSITIVITY IN MY LEFT EYE. BINOCULAR VISION DYSFUNCTION: BOTH EYES DO NOT COOPERATE TO FORM A SINGLE COHERENT IMAGE. THE VISUAL EXPERIENCE IS SIMILAR TO WEARING A CORRECTIVE LENS IN ONE EYE AND NOT THE OTHER, MAKING IT DIFFICULT FOR MY BRAIN TO MERGE THE IMAGES FROM BOTH EYES. REDUCED PERIPHERAL VISUAL FIELD IN THE LEFT EYE. MY PERIPHERAL VISION IN THE LEFT EYE FEELS ABNORMALLY RESTRICTED COMPARED TO BEFORE SURGERY. SEVERE DRY EYE THAT WAS NOT PRESENT PRIOR TO SURGERY, PARTICULARLY PRONOUNCED IN THE MORNING. MULTIPLE TREATMENTS HAVE BEEN ATTEMPTED WITHOUT ANY IMPROVEMENT, INCLUDING CEQUA (CYCLOSPORINE OPHTHALMIC SOLUTION), RESTASIS, PRESERVATIVE-FREE ARTIFICIAL TEARS, AND HEATED EYE COMPRESSES. MONOCULAR DIPLOPIA AND GHOSTING ON HIGH-CONTRAST BACKGROUNDS SUCH AS COMPUTER SCREENS, ISOLATED TO THE LEFT EYE. THIS SIGNIFICANTLY IMPACTS MY ABILITY TO WORK ON A COMPUTER. THE LEFT EYE EXPERIENCES HALOS, CORONAS, AND LIGHT STREAKS THAT EXTEND DOWNWARD AND TO THE RIGHT FROM BRIGHT LIGHTS AND BRIGHT OBJECTS IN REGULAR LIGHTING. PERSISTENT STRAY LIGHT AND VISUAL NOISE IN THE LEFT EYE. THERE IS AN OVERALL SENSE OF VISUAL CLUTTER IN MY LEFT EYE -- SCATTERED LIGHT, STRAY LIGHT ARTIFACTS, AND VARIOUS LIGHT-BASED ABERRATIONS THAT ARE NOT PRESENT IN MY RIGHT EYE. THIS MAKES THE IMAGE IN MY LEFT EYE FEEL BUSY AND VISUALLY NOISY COMPARED TO THE CLEAN IMAGE IN MY RIGHT EYE, CONTRIBUTING TO DIFFICULTY FOCUSING WITH BOTH EYES OPEN DUE TO THE SIGNIFICANT DIFFERENCE IN VISUAL QUALITY BETWEEN THE TWO EYES. ALL OF THESE SYMPTOMS HAVE BEEN PRESENT FROM THE BEGINNING, IMMEDIATELY FOLLOWING THE ICL IMPLANTATION SURGERY, AND HAVE PERSISTED FOR APPROXIMATELY ONE YEAR WITH NO IMPROVEMENT. THESE ISSUES SIGNIFICANTLY IMPACT MY DAILY ACTIVITIES INCLUDING COMPUTER USE, DRIVING AT NIGHT, AND OVERALL QUALITY OF LIFE. I HAVE SOUGHT TREATMENT FOR THESE PROBLEMS BUT THEY HAVE NOT BEEN ADEQUATELY ADDRESSED OR RESOLVED. PATIENT CODE: 2140, 4471, 1814, 2227, 4581. DEVICE: 1670, 2978. REFERENCE REPORT: MW5184304.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    484875 EVO VISIAN ICL PHAKIC TORIC INTRAOCULAR LENS QCB STAAR SURGICAL COMPANY VTICM5 13.2

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Male Disability FLONASE (FLUTICASONE PROPIONATE NASAL SPRAY)| PANTOPRAZOLE 40MG EC TAB CEQUA (CYCLOSPORINE OPHTHALMIC SOLUTION 0.09%) - 2X DAILY