BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE COLLAMER LENS (ICL)

    MDR report key: 17656079 · Received August 30, 2023

    Report

    Report Number
    2023826-2023-03700
    Event Type
    Injury
    Date Received
    August 30, 2023
    Date of Event
    July 24, 2023
    Report Date
    August 18, 2023
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    QCB
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6-DEVICE CODE 1494: OFF-LABEL USE (ACD < 3.0MM). CLAIM#: (B)(4).

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: B4- DATE OF THIS REPORT: "08/01/1991" SHOULD BE REMOVED AND "08/18/2023" SHOULD BE ADDED. CLAIM# (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL DATA: H3 - TYPE OF INVESTIGATION CODE: 10- DEVICE EVALUATION: THE LENS WAS RETURNED IN A MICROCENTRIFUGE VIAL WITH LIQUID. VISUAL INSPECTION FOUND HAPTIC BROKEN. DIMENSIONAL INSPECTION FOUND THE LENS TO BE WITHIN SPECIFICATIONS. CLAIM# (B)(4).

    Description of Event or Problem · 0

    THE REPORTER INDICATED THAT A 12.1MM VTICMO 12.1 OF -5.50/2.0/091 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENTS LEFT EYE (OS) ON (B)(6) 2023. ON (B)(6) 2023 THE LENS WAS EXCHANGED FOR A LONGER LENGTH LENS AND THE PROBLEM WAS NOT RESOLVED. REFERENCE MFR # 2023826-2023-03766 FOR EXCHANGE LENS THAT RESOLVED THE PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1514007 IMPLANTABLE COLLAMER LENS (ICL) PHAKIC TORIC INTRAOCULAR LENS QCB STAAR SURGICAL COMPANY VTICMO 12.1 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Female Required Intervention