BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 6323359 · Received February 10, 2017

    Report

    Report Number
    2023826-2016-01547
    Event Type
    Malfunction
    Date Received
    February 10, 2017
    Date of Event
    July 28, 2016
    Report Date
    October 12, 2016
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    QCB
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510(K): NA THIS PRODUCT IS MANUFACTURED IN THE U.S. BUT NOT MARKETED IN THE U.S NO ADDITIONAL SIMILAR COMPLAINT TYPE EVENTS WITHIN ASSOCIATED LOTS WERE FOUND. (B)(4). THIS IS A RESUBMISSION OF THE INITIAL MDR PER FDA REQUEST.

    Description of Event or Problem · 1

    THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.1MM VTICMO12.1 IMPLANTABLE COLLAMER LENS -8.0/+2.0/62 DIOPTER, IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2016. THE PATIENT EXPERIENCED REFRACTIVE SURPRISE, BLURRED VISION AND DIPLOPIA (DOUBLE VISION). THE PATIENT'S POST-OP BEST CORRECTED VISUAL ACUITY WAS 20/60. THE LENS REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107257 ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS QCB STAAR SURGICAL COMPANY VTICMO12.1 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Unknown