BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 6196969 · Received December 21, 2016

    Report

    Report Number
    2023826-2016-01803
    Event Type
    Injury
    Date Received
    December 21, 2016
    Date of Event
    September 22, 2016
    Report Date
    November 22, 2016
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE LENS WAS RETURNED DRY IN THE CASE/VIAL; SURGICAL RESIDUE WAS CLEARED; VISUAL INSPECTION FOUND HAPTIC BROKEN. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6 MM VICMO12.6 IMPLANTABLE COLLAMER LENS, -3.50 DIOPTER IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2016 AND IT WAS NOTED THAT THE LENS WAS TORN. THE LENS WAS EXPLANTED ON (B)(6) 2016 AND EXCHANGED FOR A LENS THE SAME SIZE, MODEL AND DIOPTER AND THE PROBLEM WAS RESOLVED. THERE WAS NO REPORT 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
    842981 ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY VICMO12.6 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Required Intervention