BEUDAMED
    FDA Adverse Event Other Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 1327512 · Received February 26, 2009

    Report

    Report Number
    2023826-2009-00181
    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
    Health Professional
    N

    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.

    Additional Manufacturer Narrative · 1

    RESULTS - PER MEDICAL SCIENTIFIC LIAISON -GLARES AND HALOS MAY BE NOTED BY PATIENTS EVEN IF THEY NEVER HAD ANY OCULAR SURGERY. THIS IS COMMONLY DUE TO ABERRATIONS OR IRREGULARITIES IN THE CORNEA IT MAY BE NOTED MORE AT LOW LIGHT CONDITIONS WHEN THE PUPIL IS DILATED. IN ICL SURGERY, THE CORNEA IS NOT TOUCHED, THEREFORE PATIENTS WHO HAVE GLARES AND HALOES BEFORE THE SURGERY, WILL COMMONLY RETAIN THESE SYMPTOMS BUT NO INCREASE IN SEVERITY SHOULD BE EXPERIENCED SINCE THE CORNEA REMAINS UNTOUCHED. THE GLARES AND HALOES HOWEVER, MAY BE PERCEIVED MORE DUE TO THE INCREASED CLARITY OF VISION. FURTHERMORE, THE EFFECTIVE OPTICAL CORNEAL ZONES (EOCZ) OF THE LENSES HAVE A MAXIMUM OF 6.17 TO 7.30 MM DEPENDING ON THE ICL POWERS. THIS IS A DESIGN LIMITATION WHICH MAY CREATE SIMILAR SYMPTOMS DUE TO THE INTERFACE OF THE OPTICAL ZONE AND THE PATIENT'S OPTICAL FIELD OF VISION, WHICH MAY BE NOTED WHEN THE PUPIL SIZE IS GREATER THAN THE EOCZ. GLARES AND HALOS ARE COMMONLY TEMPORARY, LASTING 1-6 MONTHS, BUT MAY ON VERY RARE OCCASIONS BECOME PERMANENT.

    Description of Event or Problem · 1

    THE PT REPORTED SHE HAD A 12.6MM MICL 12.6 IMPLANTABLE COLLAMER LENS IMPLANTED IN 2008, IN HER LEFT (OS) 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 Female