BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE COLLAMER LENS (ICL)

    MDR report key: 21351277 · Received February 10, 2025

    Report

    Report Number
    2023826-2025-00243
    Event Type
    Injury
    Date Received
    February 10, 2025
    Report Date
    January 16, 2025
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    QCB
    UDI-DI
    00841542120869
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6- INVESTIGATION TYPE CODE: 4110- LENS WORK ORDER SEARCH-NO SIMILAR COMPLAINT EVENT(S) WITHIN ASSOCIATED LOTS WERE FOUND. H11- MANUFACTURER NARRATIVE: 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 HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED RESIDUAL REFRACTIVE ERROR. REPORTEDLY, "I EXCHANGED THESE LENSES IN NYC (DR MOADEL'S CLINIC)". IN A SEPARATE SURGERY THE LENS WAS EXCHANGED AND REPLACED. 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- HEALTH EFFECT- IMPACT CODE (F): "4627" SHOULD BE REMOVED AND "4629" SHOULD BE ADDED. CLAIM# (B)(4).

    Description of Event or Problem · 0

    A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED RESIDUAL REFRACTIVE ERROR. REPORTEDLY, "I EXCHANGED THESE LENSES IN NYC (DR MOADEL'S CLINIC)". LENS WAS EXPLANTED AND REPLACED. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1657850 IMPLANTABLE COLLAMER LENS (ICL) PHAKIC TORIC INTRAOCULAR LENS QCB STAAR SURGICAL COMPANY VTICMO 13.2 N/A 00841542120869

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention CARTRIDGE MODEL-SFC-45, LOT#-UNK| FOAM TIP PLUNGER MODEL-FTP, LOT#-UNK| INJECTOR MODEL-MSI-PF, LOT#-UNK