BEUDAMED
    FDA Adverse Event Other Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 1022529 · Received March 26, 2008

    Report

    Report Number
    2023826-2008-00425
    Event Type
    Other
    Date Received
    March 26, 2008
    Report Date
    March 5, 2008
    Manufacturer
    STAAR SURGICAL
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A WORK ORDER SEARCH WAS PERFORMED FOR SIMILAR COMPLAINTS WITHIN THE SEARCH AND NO SIMILAR COMPLAINTS WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON INSERTED A VISIAN ICL (IMPLANTABLE COLLAMER LENS MODEL MICL 12.6MM IN 2008, AND THE PATIENT IS EXPERIENCING HALOS AND GLARE POSTOPERATIVELY. THE LENS REMAINS IMPLANTED. THE PATIENT HAS OCULAR HYPERTENSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISIAN ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL MICL 12.6 NA

    Patients

    Seq Age Sex Outcome Treatment
    1