BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 2480284 · Received February 28, 2012

    Report

    Report Number
    2023826-2012-00153
    Event Type
    Malfunction
    Date Received
    February 28, 2012
    Date of Event
    January 31, 2012
    Report Date
    January 31, 2012
    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 HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (METHOD) - LENS WORK ORDER SEARCH. (RESULTS) - VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND ALMOST WHOLE PART OF ONE HAPTIC AND PIECE OF OPTIC IS TORN OFF AND MISSING. LENS WAS RETURNED IN LIQUID. A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOUND WITHIN THE SAME WORK ORDER. (CONCLUSIONS) - BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH AND THE EVALUATION OF THE RETURNED PRODUCT, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON USED AN MICL 13.2MM IMPLANTABLE COLLAMER LENS. THE SURGEON WAS ADVANCING THE LENS INTO THE RIGHT EYE INCISION. IT WAS PARTIALLY IN THE EYE WHEN THE LENS GOT CAUGHT AND TORE AS IT WAS COMING OUT OF THE INJECTOR. THE SURGEON WAS ABLE TO PULL THE LENS OUT OF THE EYE WITH THE LENS STILL PARTIALLY INSIDE THE INJECTOR/CARTRIDGE. THERE WAS NO PATIENT INJURY. ANOTHER SAME MODEL AND SIZE LENS WAS IMPLANTED. NO LOT NUMBERS WERE PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR CARTRIDGE: MODEL SFC-45 FP| INJECTOR: MODEL MSI-PF| FOAM TIP PLUNGER