BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 6153430 · Received December 7, 2016

    Report

    Report Number
    2023826-2016-01744
    Event Type
    Injury
    Date Received
    December 7, 2016
    Report Date
    November 7, 2016
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    MFR DATE- 05-25-2012. WORK ORDER SEARCH: NO SIMILAR COMPLAINTS WERE FOUND. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT REPORTED THE SURGEON IMPLANTED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -8.5 DIOPTER, IN HER RIGHT EYE (OD). THE PATIENT REPORTED HER VISION WAS SLIGHTLY BLURRY AT NIGHT AND IN DIM LIGHTING. THE LENS WAS IMPLANTED ON (B)(6) 2010 AND REMAINS IMPLANTED. THE FACILITY CONFIRMED THE INFORMATION AND INDICATED THE EVENT WAS DUE TO THE PATIENT HAD LARGE PUPILS AND WAS NOT DEVICE RELATED. NO OTHER COMPLICATIONS WERE REPORTED. PATIENT'S POST-OP VISUAL ACUITY WAS 20/20 AND THE OUTCOME WAS EXCELLENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    803198 ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY MICL13.2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR