BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 1111734 · Received August 13, 2008

    Report

    Report Number
    2023826-2008-01051
    Event Type
    Injury
    Date Received
    August 13, 2008
    Date of Event
    July 10, 2008
    Report Date
    July 15, 2008
    Manufacturer
    STAAR SURGICAL
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL INSPECTION OF THE RETURNED PRODUCT SHOWS A PORTION OF A HAPTIC IS TORN OFF AND IS MISSING. THERE IS CLEAR SURGICAL RESIDUE ON THE LENS. A LENS SERIAL WORK ORDER SEARCH WAS PERFORMED FOR SIMILAR COMPLAINTS WITHIN THE SEARCH AND NO SIMILAR COMPLAINTS WERE FOUND. CONCLUSION: GLARES AND HALOS MAY BE NOTED BY PTS 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, PTS 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.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE SURGEON INSERTED A VISIAN ICL (IMPLANTABLE COLLAMER LENS) MODEL MICL 12.6MM IN 2008, AND EXPLANTED IT THREE MONTHS LATER, DUE TO PT HAD EXPERIENCED GLARE AND HALOS. PT HAD A MARGINAL ANTERIOR CHAMBER DEPTH AND THE PT WAS OVER THE AGE RECOMMENDED FOR THIS TYPE OF LENS. NO NEW LENS WILL BE PUT IN.

    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 Required Intervention INJECTOR MODEL: UNK| FOAM TIP PLUNGER UNK| CARTRIDGE MODEL: SFC-45FP