BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 2191015 · Received July 19, 2011

    Report

    Report Number
    2023826-2011-00649
    Event Type
    Malfunction
    Date Received
    July 19, 2011
    Date of Event
    July 7, 2011
    Report Date
    July 18, 2011
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LENS FLIPPED AND INSERTED UPSIDE DOWN. METHOD: LENS WORK ORDER SEARCH. RESULTS: A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOUND WITHIN THE SAME WORK ORDER. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON INSERTED AN MICL 12.6MM IMPLANTABLE COLLAMER LENS IN THE PATIENT'S RIGHT EYE. THE LENS FLIPPED DURING INSERTION INTO THE EYE AND WAS IMPLANTED UPSIDE DOWN. THE LENS WAS REMOVED WITH NO PATIENT INJURY. THE INCISION WAS NOT WIDENED AND NO SUTURE WAS USED. ANOTHER SAME MODEL AND SIZE LENS WAS IMPLANTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR INJECTOR: MODEL MSI-PF, LOT NUMBER UNK| CARTRIDGE: MODEL SFC-45 FP, LOT NUMBER UNK| FOAM TIP PLUNGER: MODEL, LOT NUMBER UNK