BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVO/EVO+ VISIAN IMPLANTABLE COLLAMER LENS

    MDR report key: 24822964 · Received April 8, 2026

    Report

    Report Number
    2023826-2026-00611
    Event Type
    Injury
    Date Received
    April 8, 2026
    Date of Event
    March 10, 2026
    Report Date
    April 8, 2026
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    UDI-DI
    00840311302253
    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-CLINICAL CODE 4581- SIGNIFICANT REDUCTION OF IRIDOCORNEAL ANGLES, SHALLOWING OF THE AC SECONDARY SURGICAL INTERVENTION TO REMOVE/REPLACE/REPOSITION THE LENS IS IDENTIFIED IN THE LABELING AS A KNOWN POTENTIAL ADVERSE EVENT FOLLOWING ICL IMPLANTATION. 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 AN EXCESSIVE VAULT WITH SIGNIFICANT REDUCTION OF IRIDOCORNEAL ANGLES, SHALLOWING OF THE AC AND ELEVATED IOP. MEDICAL TREATMENT FOR IOP WAS GIVEN. IN A SEPARATE VISIT THE LENS WAS EXCHANGED FOR A SHORTER LENGTH LENS. THE REPLACEMENT LENS RESOLVED THE PROBLEM. THIS REPORT IS 1 OF 2 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
    882462 EVO/EVO+ VISIAN IMPLANTABLE COLLAMER LENS PHAKIC INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY VICMO 13.2 -02.50 NA 00840311302253

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female Required Intervention