BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 2926116 · Received January 16, 2013

    Report

    Report Number
    2023826-2013-00062
    Event Type
    Injury
    Date Received
    January 16, 2013
    Report Date
    December 17, 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). EVAL, METHOD: A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOUND WITHIN THE WORK ORDER. CONCLUSIONS: (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) 2007. AS PART OF THE POST MARKET STUDY, THE PT REPORTED DOCTOR PRESCRIBED EYE DROPS FOR HIGH PRESSURE OR GLAUCOMA. THE ICL REMAINS IMPLANTED. SEE MFR# 2023826-2013-00061 FOR LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25080 VISIAN ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY MICL12.6 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention