BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 6042652 · Received October 19, 2016

    Report

    Report Number
    2023826-2016-01427
    Event Type
    Injury
    Date Received
    October 19, 2016
    Date of Event
    May 2, 2016
    Report Date
    September 27, 2016
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS MANUFACTURED IN THE U.S. BUT NOT MARKETED IN THE U.S. (B)(4). CLAIM # (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: DEVICE EVALUATION - THE LENS WAS RETURNED IN A LENS CASE/VIAL. VISUAL INSPECTION FOUND THE HAPTIC BROKEN AND FIBERS ON THE LENS SURFACE. (B)(4). WORK ORDER SEARCH - NO SIMILAR COMPLAINTS WERE REPORTED FOR UNITS WITHIN THE SAME LOT. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER INDICATED THE SURGEON INSERTED A 12.6MM VTICMO12.6 IMPLANTABLE COLLAMER LENS, -14.0/+3.5/079 DIOPTER, AND THE LENS TORE/BROKE DURING INJECTION/DELIVERY INTO THE EYE. THE LENS WAS REMOVED ON (B)(6) 2016 AND ANOTHER SAME MODEL BUT DIFFERENT DIOPTER LENS WAS IMPLANTED ON (B)(6) 2016. THE EXCHANGED LENS RESOLVED THE PROBLEM AND THERE WAS NO INDICATION OF ANY APPARENT INJURY. THE PATIENT'S POST-OP BEST-CORRECTED VISUAL ACUITY WAS 20/20.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693263 ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY VTICMO12.6 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Required Intervention