BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVO/EVO+VISIAN IMPLANTABLE COLLAMER LENS

    MDR report key: 21833704 · Received April 14, 2025

    Report

    Report Number
    2023826-2025-00553
    Event Type
    Injury
    Date Received
    April 14, 2025
    Date of Event
    March 21, 2025
    Report Date
    April 14, 2025
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    QCB
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE LABELING WAS COMPLETED. IRITIS/UVEITIS/ENDOPHTHALMITIS ARE IDENTIFIED IN THE LABELING AS KNOWN ADVERSE EVENTS FOLLOWING ICL IMPLANTATION. THE DFU PROVIDES THE SURGEON INSTRUCTION FOR COMPLETE OVD REMOVAL. PRECAUTION: (6) AFTER INSERTING THIS PRODUCT, ASPIRATE THE VISCOELASTIC SUBSTANCE COMPLETELY FROM INSIDE THE EYE. DO NOT USE HIGHLY VISCOUS VISCOELASTIC SUBSTANCES THAT ARE DIFFICULT TO ASPIRATE COMPLETELY. (10) THIS PRODUCT SHOULD NOT BE IMMERSED IN ANYTHING OTHER THAN COMMONLY USED INTRAOCULAR IRRIGATION FLUIDS OR VISCOELASTIC SUBSTANCES. UNDER HOW TO USE: (8) COMPLETELY REMOVE THE VISCOELASTIC SUBSTANCE FROM THE EYE AND MIOSIS THE PUPIL. H6: INVESTIGATION TYPE 4110: LENS WORK ORDER SEARCH, NO SIMILAR COMPLAINT EVENT(S) WITHIN ASSOCIATED LOTS WERE FOUND. CLAIM# (B)(4).

    Description of Event or Problem · 0

    A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN VTICM5 13.2MM IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED UVEITIS/IRITIS, ELEVATED IOP, PIGMENT DISPERSION, BLURRED VISION, IRIS ATROPHY, UNREACTIVE PUPIL, AND MASSIVE SUBACUTE PIGMENT DISPERSION GLAUCOMA. NO DIAGNOSTIC CULTURES WERE PERFORMED. BILATERAL SEQUENTIAL SURGERY WAS PERFORMED. OCULAR HTN TREATED WITH ORAL AND TOPICAL MEDICATIONS. MOXIFLOXACIN AND PREDNISOLONE WERE USED. PATIENT WAS PERFECTLY COMPLIANT. BCVA/UCVA WERE BOTH NOTED AT 20/20. CAUSE OF EVENT WAS REPORTED AS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1091553 EVO/EVO+VISIAN IMPLANTABLE COLLAMER LENS PHAKIC TORIC INTRAOCULAR LENS QCB STAAR SURGICAL COMPANY VTICM5 13.2 (-11.00/1.0)

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Female Other FOAM TIP PLUNGER, LOT# UNK.| MSI-PF, LOT# UNK.| SFC-45, LOT# UNK.