BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVO/EVO + VISIAN IMPLANTABLE COLLAMER LENS (ICL)

    MDR report key: 23518832 · Received November 10, 2025

    Report

    Report Number
    2023826-2025-01631
    Event Type
    Injury
    Date Received
    November 10, 2025
    Date of Event
    October 10, 2025
    Report Date
    November 10, 2025
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    QCB
    UDI-DI
    00841542135283
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL DATA: D4. MODEL- 'VTICM5_13.2 (-14.50/ 2.5)' SHOULD BE REMOVED AND 'VTICMO 13.2 (-14.50/ 2.5)' SHOULD BE ADDED. D4. CATALOG#- 'VTICM5_ 13.2' SHOULD BE REMOVED AND 'VTICMO 13.2' SHOULD BE ADDED. D4. EXPIRATION DATE- '04/30/2025' SHOULD BE REMOVED AND '05/31/2025' SHOULD BE ADDED. D4. PRIMARY UNIQUE DEVICE IDENTIFIER (UDI)#- (B)(4) SHOULD BE ADDED. E1.- '(BE) SIMOVISION BV SIMOVISION BV VRIENDSCHAPSSTRAAT 30, OVERIJSE 30.90' SHOULD BE REMOVED AND 'TRANSMEDIC PHILIPPINES INC. UNIT 9A 9/F PETRON MEGA PLAZA, SEN. GIL PUYAT AVE. BEL-AIR MAKATI CITY' SHOULD BE ADDED. H6- TYPE OF INVESTIGATION CODE: 4110- LENS WORK ORDER SEARCH- ONE SIMILAR COMPLAINT EVENT(S) WITHIN ASSOCIATED LOTS WERE FOUND. CLAIM# (B)(4).

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: D4. MANUFACTURER DATE: '05/08/2022' SHOULD BE REMOVED AND '06/17/2022' SHOULD BE ADDED. CLAIM# (B)(4).

    Additional Manufacturer Narrative · 0

    H6- INVESTIGATION TYPE CODE: 4110- LENS WORK ORDER SEARCH-NO SIMILAR COMPLAINT EVENT(S) WITHIN ASSOCIATED LOTS WERE FOUND. H6-HEALTH EFFECT- IMPACT CODE: 4625- YAG LASER IRIDOTOMY WAS PERFORMED. H6- HEALTH EFFECT- CLINICAL CODE: 4581- SIGNIFICANT REDUCTION OF ENDOTHELIAL CELLS COUNT. H11- MANUFACTURER NARRATIVE: ADDITIONAL YAG IRIDOTOMY 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 AND SIGNIFICANT REDUCTION OF ENDOTHELIAL CELLS COUNT. ADDITION OF NEW PI AND STATUS POST YAG LASER IRIDOTOMY WAS PERFORMED. THE LENS REMAINS IMPLANTED. REPORTEDLY, "PATIENT IS EXPECTED FOR FOLLOW UP THIS JANUARY". THE CAUSE OF THE EVENT WAS REPORTED AS THE DEVICE. THERE ARE MULTIPLE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS 2 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. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492850 EVO/EVO + VISIAN IMPLANTABLE COLLAMER LENS (ICL) PHAKIC TORIC INTRAOCULAR LENS QCB STAAR SURGICAL COMPANY VTICMO 13.2 (-14.50/ 2.5) N/A 00841542135283

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Male Required Intervention CARTRIDGE MODEL: SFC-45: LOT# UNK.| FOAM TIP PLUNGER (FTP), LOT# UNK.| INJECTOR MODEL: MSI-PF, LOT# UNK.