BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVO/EVO+ VISIAN IMPLANTABLE COLLAMER LENS (ICL)

    MDR report key: 23405234 · Received October 28, 2025

    Report

    Report Number
    2023826-2025-01690
    Event Type
    Injury
    Date Received
    October 28, 2025
    Date of Event
    October 20, 2025
    Report Date
    October 28, 2025
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    QCB
    UDI-DI
    00840311312078
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6 - WORK ORDER SEARCH: NO ADDITIONAL SIMILAR COMPLAINT TYPE EVENTS WITHIN ASSOCIATED LOTS WERE FOUND. IOP ELEVATION FROM BASELINE AND 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).

    Additional Manufacturer Narrative · 0

    B5 - THE REPORTER INDICATED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED EXCESSIVE VAULT, SIGNIFICANT REDUCTION OF IRIDOCORNEAL ANGLES AND ELEVATED IOP. DUE TO EXCESSIVE VAULT, SIGNIFICANT REDUCTION OF IRIDOCORNEAL ANGLES AND ELEVATED IOP, MEDICATION WAS ADMINISTERED. THIS DID NOT RESOLVE THE ISSUE. THE LENS WAS EXCHANGED FOR A SHORTER LENGTH LENS. THE PROBLEM WAS RESOLVED. CAUSE OF THE EVENT WAS REPORTED AS DEVICE. H6 - TYPE OF INVESTIGATION 3331 - DEVICE HISTORY RECORD (DHR) REVIEW: BASED ON THE RESULTS OF THE INVESTIGATION, ALL RELEASED DEVICES FROM THE ASSOCIATED WORK ORDER(S), INCLUDING THE SUSPECTED DEVICE, HAVE BEEN MANUFACTURED WITHIN ESTABLISHED PROCESS PARAMETERS AND THERE IS NO INDICATION THAT THE MANUFACTURING AND PROCESSING OF THE DEVICE CONTRIBUTED TO THE COMPLAINT ISSUE. (B)(4).

    Description of Event or Problem · 0

    THE REPORTER INDICATED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED EXCESSIVE VAULT, NARROW ANGLES AND ELEVATED IOP. DUE TO EXCESSIVE VAULT, NARROW ANGLES AND ELEVATED IOP, MEDICATION WAS ADMINISTERED. THIS DID NOT RESOLVE THE ISSUE. THE LENS WAS EXCHANGED FOR A SHORTER LENGTH LENS. THE PROBLEM WAS RESOLVED. CAUSE OF THE EVENT WAS REPORTED AS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2028182 EVO/EVO+ VISIAN IMPLANTABLE COLLAMER LENS (ICL) PHAKIC TORIC INTRAOCULAR LENS QCB STAAR SURGICAL COMPANY VTICM5_13.2(-12.5/2.5) N/A 00840311312078

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Female Required Intervention CARTRIDGE MODEL-UNK, LOT#-UNK.| INJECTOR MODEL-LIOLI-24, LOT#-UNK.| UNK-MODEL-UNK, LOT#-UNK.