BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 6451341 · Received March 31, 2017

    Report

    Report Number
    2023826-2016-01627
    Event Type
    Malfunction
    Date Received
    March 31, 2017
    Date of Event
    July 7, 2016
    Report Date
    October 25, 2016
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    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 12.6MM VICMO12.6 IMPLANTABLE COLLAMER LENS -12.5 DIOPTER, IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2016. THE LENS WAS EXPLANTED ON (B)(6) 2016 DUE TO A LENS TEAR/BREAK DURING THE INJECTION/DELIVERY INTO THE EYE. THE LENS WAS EXCHANGED FOR AN IDENTICAL LENS WITH THE SAME DIOPTER. THE PATIENT'S POST-OP BEST CORRECTED VISUAL ACUITY WAS 20/20.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233853 ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY VICMO12.6 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Unknown