BEUDAMED
    FDA Adverse Event Other Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 1327513 · Received February 26, 2009

    Report

    Report Number
    2023826-2009-00182
    Event Type
    Other
    Date Received
    February 26, 2009
    Report Date
    January 29, 2009
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: RESULTS: A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINT WAS FOUND WITHIN THE WORK ORDER. CONCLUSION: BASED ON THE COMPLAINT HISTORY AND WORK ORDER SEARCH, THE ROOT CAUSE OF THE EVENT HAS BEEN DETERMINED TO BE DUE TO PT RELATED PROBLEM AND IS NOT LENS RELATED.

    Description of Event or Problem · 1

    THE PATIENT REPORTED SHE HAD A 12.6MM MICL 12.6 IMPLANTABLE COLLAMER LENS IMPLANTED IN 2008, IN HER RIGHT (OD) EYE. THE PT REPORTED SHE IS EXPERIENCING HALOS ALL THE TIME - DAY AND NIGHT. THE FACILITY STATED THE PT HAS HAD A HISTORY OF CORNEAL PROBLEMS AND IT IS FELT THAT THE EVENT WITH HALOS IS RELATED TO THE CORNEAL PROBLEMS AND WAS NOT ICL RELATED. SHE WAS GIVEN EYE DROPS TO KEEP THE CORNEA MOIST. THE LENS REMAINS IMPLANTED. THE PATIENT'S CURRENT BCVA IS 20/20.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1