BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 2915081 · Received January 10, 2013

    Report

    Report Number
    2023826-2013-00030
    Event Type
    Injury
    Date Received
    January 10, 2013
    Date of Event
    December 14, 2012
    Report Date
    December 12, 2012
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHODS: LENS WORK ORDER SEARCH. RESULTS: A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOUND WITHIN THE SAME WORK ORDER. CONCLUSIONS: BASE ON THE COMPLAINT HISTORY AND WORK ORDER SEARCH, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON IMPLANTED A MICL 12.6 MM IMPLANTABLE COLLAMER LENS IN THE PATIENT'S LEFT EYE ON (B)(6) 2012. ON (B)(6) 2012, THE ICL WAS EXPLANTED AND EXCHANGED FOR A SHORTER LENGTH LENS. THE ICL WAS DISCARDED. FURTHER INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED WHEN FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13909 VISIAN ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL CO. MICL12.6 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention FOAM TIP PLUNGER: MODEL - LOT NUMBER - UNK| INJECTOR: MODEL AND LOT NUMBER - UNK| CARTRIDGE: MODEL AND LOT NUMBER - UNK