BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVO/EVO+ VISIAN IMPLANTABLE COLLAMER LENS (ICL)

    MDR report key: 23968075 · Received January 5, 2026

    Report

    Report Number
    2023826-2026-00008
    Event Type
    Injury
    Date Received
    January 5, 2026
    Report Date
    January 5, 2026
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    UDI-DI
    00840311300204
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IOP ELEVATION FROM BASELINE 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

    CORRECTED DATA: B5.- A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING A IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION REPLACEMENT PROCEDURE, THE PATIENT EXPERIENCED AN ELEVATED IOP. MEDICATION WAS PRESCRIBED. REPORTEDLY, '12MMHG. THE ISSUE WAS REPORTED AS RESOLVED. HOWEVER, AS PER THE FOLLOW UP EMAIL, THE REPORTER STATED THAT "SINCE THE IOP STAYED HIGH, BRIMONIDINE TARTRATE WAS ADMINISTERED ONLY AFTER THE LENS REPLACEMENT. CURRENTLY, THE PATIENT'S IOP IS AT A STABLE LEVER OF 12 MMHG'. LENS REMAINS IMPLANTED. THERE ARE MULTIPLE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. 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. H6- INVESTIGATION TYPE CODE: 4110- LENS WORK ORDER SEARCH-NO SIMILAR COMPLAINT EVENT(S) WITHIN ASSOCIATED LOTS WERE FOUND. CLAIM# (B)(4).

    Description of Event or Problem · 0

    THE REPORTER INDICATED THAT FOLLOWING A REPLACEMENT IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED ELEVATED IOP. DUE TO ELEVATED IOP, MEDICATION WAS ADMINISTERED. THE PROBLEM WAS RESOLVED. CAUSE OF EVEN IS UNKNOWN. THERE ARE MULTIPLE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. 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. ADDITIONAL INFORMATION WAS REQUESTED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THIS FILE WILL BE RE-OPENED IF ADDITIONAL INFORMATION IS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21752 EVO/EVO+ VISIAN IMPLANTABLE COLLAMER LENS (ICL) PHAKIC INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY VICM5_12.1(-6.5) N/A 00840311300204

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention CARTRIDGE MODEL-UNK, LOT#-UNK.| INJECTOR MODEL-UNK,LOT#-UNK.| UNK-MODEL-UNK, LOT#-UNK.