BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 2810014 · Received October 23, 2012

    Report

    Report Number
    2023826-2012-00849
    Event Type
    Injury
    Date Received
    October 23, 2012
    Date of Event
    September 13, 2012
    Report Date
    September 25, 2012
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD - LENS WORK ORDER SEARCH. RESULT - A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOUND WITHIN THE WORK ORDER. CONCLUSION - (NO CONCLUSION CAN BE DRAWN): 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 RIGHT EYE ON (B)(6) 2008. AS PART OF THE POST MARKET STUDY, THE PT REPORTED USING EYE DROPS FOR IRITIS. THE ICL REMAINS IMPLANTED. FURTHER INFO HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED WHEN FURTHER IS AVAILABLE. SEE MFR #2023826-2012-00850 LEFT EYE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention CARTRIDGE: MODEL & LOT # UNK| FORM TIP PLUNGER: MODEL & LOT # UNK| INJECTOR: MODEL & LOT # UNK