BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 6077699 · Received November 3, 2016

    Report

    Report Number
    2023826-2016-01563
    Event Type
    Injury
    Date Received
    November 3, 2016
    Date of Event
    March 19, 2016
    Report Date
    October 11, 2016
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510(K): N/A THIS PRODUCT IS MANUFACTURED IN THE U.S. BUT NOT MARKETED IN THE U.S. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: PRODUCT EVALUATION FOUND THAT THE LENS WAS RETURNED DRY IN THE LENS CONTAINER, BUT THERE IS CLEAR SURGICAL RESIDUE/DEBRIS ON PRODUCT. VISUAL INSPECTION FOUND HAPTIC TORN/BROKEN. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 11.5 MM ICM115V4 IMPLANTABLE COLLAMER LENS, -14.0 DIOPTER IN TO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2013. THE LENS WAS EXPLANTED ON (B)(6) 2016 DUE TO LOW VAULT. THE LENS WAS EXCHANGED FOR A LONGER LENS AND THE PROBLEM WAS RESOLVED. THE PATIENT'S POST-OP BEST CORRECTED VISUAL ACUITY WAS 20/20.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726458 ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY ICM115V4 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Required Intervention