BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 2930418 · Received January 23, 2013

    Report

    Report Number
    2023826-2013-00088
    Event Type
    Injury
    Date Received
    January 23, 2013
    Report Date
    December 10, 2012
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    IT WAS REPORTED PT HAD A MICL 12.6MM IMPLANTABLE COLLAMER LENS IMPLANTED IN THE LEFT EYE ON (B)(6) 2008. AS PART OF THE POST MARKET STUDY, THE PT REPORTED EXPERIENCING MINIMAL LOST OF VISION DUE TO DEVELOPMENT OF A SLIGHT CATARACT. ICL REMAINS IMPLANTED. FURTHER INFO HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED WHEN FURTHER INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32939 VISIAN ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY MICL12.6 NA

    Patients

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