BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE COLLAMER LENS (ICL)

    MDR report key: 18773149 · Received February 23, 2024

    Report

    Report Number
    2023826-2024-00806
    Event Type
    Injury
    Date Received
    February 23, 2024
    Date of Event
    January 22, 2024
    Report Date
    January 25, 2024
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    QCB
    UDI-DI
    00840311311149
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: CLINICAL CODE: 4581: IRIS ATROPHY. H6: INVESTIGATION TYPE 4110: LENS WORK ORDER SEARCH: NO SIMILAR COMPLAINT EVENT(S) WITHIN ASSOCIATED LOTS WERE FOUND. CLAIM #: (B)(4).

    Additional Manufacturer Narrative · 0

    B1 - CORRECTED TO: ADVERSE EVENT IN THE INITIAL MDR. B2 - CORRECTED TO : REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE IN THE INITIAL MDR. H1- CORRECTED TO : SERIOUS INJURY IN THE INITIAL MDR. CLAIM #(B)(4).

    Description of Event or Problem · 0

    THE REPORTER INDICATED THAT A 13.2MM VTICM5 13.2 IMPLANTABLE COLLAMER LENS OF -8.00/1.0/055 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENTS LEFT EYE (OS) ON (B)(6) 2023. IRIS ATROPHY WAS REPORTED. THE PATIENT IS COMPLETELY ASYMPTOMATIC; PIO AND VISUAL ACUITY IS PERFECT. THE LENS REMAINS IMPLANTED. CAUSE REPORTED AS UNKNOWN. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125107 IMPLANTABLE COLLAMER LENS (ICL) PHAKIC TORIC INTRAOCULAR LENS QCB STAAR SURGICAL COMPANY VTICMO 13.2 NA 00840311311149

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Female Required Intervention INJECTOR MODEL: MSI-PF, LOT# UNK