BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 2960035 · Received February 13, 2013

    Report

    Report Number
    2023826-2013-00123
    Event Type
    Injury
    Date Received
    February 13, 2013
    Date of Event
    December 10, 2012
    Report Date
    January 15, 2013
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): VISUAL DISTURBANCES, MALPOSITION OF DEVICE. EVALUATION METHOD: WORK ORDER SEARCH. RESULTS: A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOUND WITHIN THE WORK ORDER. VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND ONE HAPTIC TORN, WITH A PIECE TORN OFF AND MISSING. THE LENS WAS RETURNED IN LIQUID. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON INSERTED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS IN THE PATIENT'S RIGHT EYE (OD) AND THE LENS TWISTED AND FLIPPED. THE INCISION WAS ENLARGED TO REMOVE THE LENS AND ANOTHER SAME MODEL LENS WAS IMPLANTED. A SUTURE WAS REQUIRED TO CLOSE THE INCISION. THE LENS WAS DAMAGED. THE REPORTER STATED A POSSIBLE CAUSE OF THE EVENT WAS DUE TO THE PATIENT WAS UNCOOPERATIVE. THERE WAS NO PRODUCT MALFUNCTION. THE PATIENT IS DOING WELL, THE VAULT IS GOOD AND VA IS 20/25.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63145 VISIAN ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY MICL12.6 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Required Intervention FOAM TIP PLUNGER: MODEL FTP, LOT NUMBER UNK| CARTRIDGE: MODEL SFC-45 FP, LOT NUMBER UNK| INJECTOR: MODEL MSI-PF, LOT NUMBER UNK