BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 1833636 · Received September 8, 2010

    Report

    Report Number
    2023826-2010-00894
    Event Type
    Injury
    Date Received
    September 8, 2010
    Report Date
    August 11, 2010
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVAL RESULTS (OTHER): A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOUND WITHIN THE WORK ORDER. CONCLUSIONS: BASED 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 INDICATED, THE SURGEON IMPLANTED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS IN THE PT'S RIGHT EYE (OD). THE LENS WAS EXPLANTED DUE TO EXCESSIVE VAULTING. SUBSEQUENTLY, THE PT EXPERIENCED SIGNIFICANT ANGLE NARROWING. THE ICL WAS EXCHANGED FOR A SHORTER LENS. ADD'L INFO HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADD'L INFO IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    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 Required Intervention FOAM TIP PLUNGER MODEL AND LOT # UNK| CARTRIDGE MODEL AND LOT # UNK| INJECTOR MODEL AND LOT # UNK