BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE COLLAMER LENS (ICL)

    MDR report key: 10930479 · Received December 1, 2020

    Report

    Report Number
    2023826-2020-02833
    Event Type
    Injury
    Date Received
    December 1, 2020
    Date of Event
    September 19, 2020
    Report Date
    November 5, 2020
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    QCB
    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: B5- THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.2MM VTICMO13.2 IMPLANTABLE COLLAMER LENS, -10.0/+2.0/089 (SPHERE/CYLINDER/AXIS) INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2019. UVEITIS; PUPIL MEMBRANE WAS CLOSED, IRIS SYNECHIA WAS REPORTED. TREATMENT OF HORMONES; NON STEROIDAL ANTI-INFLAMMATORY DRUGS, MYDRIASIS TREATMENT, TREATMENT IMPROVED, REPEATED ATTACKS, AFTER CONSULTATION DECIDED TO TAKE OUT THE LENS. ON (B)(6) 2020 THE LENS WAS EXPLANTED AND THE PROBLEM WAS RESOLVED. H3- DEVICE EVALUATION: LENS RETURNED IN A MICRO-CENTRIFUGE VIAL WITH MOISTURE. VISUAL INSPECTION FOUND HAPTIC TORN. H6 CLINICAL CODE: 4581: PUPIL MEMBRANE CLOSED; IRIS SYNECHIA. HEALTH IMPACT: 4625: MYDRIASIS TREATMENT. HEALTH IMPACT : 4644: HORMONES; NON-STEROIDAL ANTI- INFLAMMATORY DRUGS. CLAIM# (B)(4).

    Additional Manufacturer Narrative · 1

    PMA/510(K): THIS PRODUCT IS MANUFACTURED IN THE U.S. BUT NOT MARKETED IN THE U.S. INVESTIGATION TYPE 4110: LENS WORK ORDER SEARCH-NO SIMILAR COMPLAINT TYPE EVENTS REPORTED FOR UNITS WITHIN THE SAME LOT. CLAIM# (B)(4).

    Description of Event or Problem · 1

    THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.2MM VTICMO13.2 IMPLANTABLE COLLAMER LENS, -10.0/+2.0/089 (SPHERE/CYLINDER/AXIS) INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2019. ON (B)(6) 2020 THE LENS WAS EXPLANTED, DIAGNOSTICS AND TREATMENT PERFORMED. THE CAUSE OF THE EVENT IS REPORTED AS UNKNOWN. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1389748 IMPLANTABLE COLLAMER LENS (ICL) PHAKIC TORIC INTRAOCULAR LENS QCB STAAR SURGICAL COMPANY VTICMO13.2 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Required Intervention