BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE COLLAMER LENS (ICL)

    MDR report key: 8090066 · Received November 20, 2018

    Report

    Report Number
    2023826-2018-01697
    Event Type
    Injury
    Date Received
    November 20, 2018
    Date of Event
    September 2, 2018
    Report Date
    October 26, 2018
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: DEVICE EVALUATED BY MFR - DEVICE EVALUATION: THE LENS WAS RETURNED IN A MICRO CENTRIFUGE VIAL WITH MOISTURE ON LENS. THERE WAS CLEAR SURGICAL RESIDUE ON PRODUCT. VISUAL INSPECTION FOUND NO VISIBLE DAMAGE TO LENS AND RESIDUE ON LENS. CORRECTED DATA: EVENT - "HEMORRHAGE OF AN IRIS VESSEL OCCURRED" SHOULD BE CORRECTED TO "HEMORRHAGE OF AN IRIS VESSEL OCCURED LEADING TO HYPHEMA" CLAIM #(B)(4).

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS MANUFACTURED IN THE US, BUT NOT MARKETED IN THE US. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.6MM VICMO12.6 IMPLANTABLE COLLAMER LENS, DIOPTER -9.0 INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2018. ON (B)(6) 2018 THE LENS WAS EXPLANTED DUE TO LENS OPACITY (ASC). REPORTEDLY, DURING THE INITIAL PROCEDURE, HEMORRHAGE OF AN IRIS VESSEL OCCURED. TO MANAGE THE IRIS BLEED THE SURGEON INTRODUCED BUBBLES INTO THE EYE. REPORTEDLY, THE BUBLLES WERE STILL PRESENT 3 DAYS LATER AND THE ICL WAS IN CONTACT WITH THE ANTERIOR CAPSULE. THE SURGEON STATES THE CAUSE OF THE ICL TOUCHING THE ANTERIOR CAPSULE WAS DUE TO THE BUBBLES, NOT THE ICL DEVICE. THE CAUSE OF THE IRIS HEMORRHAGE AND LENS OPACITY (ASC) IS REPORTED AS UNKNOWN. THE PROBLEM WAS RESOLVED WITH THE LENS EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    929296 IMPLANTABLE COLLAMER LENS (ICL) PHAKIC INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY VICMO12.6 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Required Intervention