BEUDAMED
    FDA Adverse Event Other Summary report: N

    CORNEAL SEPARATOR, CCW, 0.9MM

    MDR report key: 1695386 · Received May 20, 2010

    Report

    Report Number
    2953726-2010-00001
    Event Type
    Other
    Date Received
    May 20, 2010
    Date of Event
    April 14, 2010
    Report Date
    May 14, 2010
    Manufacturer
    ADDITION TECHNOLOGY
    Product Code
    HNO
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS PERFORMED: TWO INSTRUMENTS WERE RETURNED FOR EVALUATION; 2 CORNEAL SEPARATORS, 1CM AND 1CCW. ALL THE RETURNED INSTRUMENTS WERE REMOVED FROM THE SHIPPING BOX AND GIVEN A QUICK VISUAL CHECK BEFORE BEING AUTOCLAVED. THE CORNEAL SEPARATORS WERE SHIPPED IN THEIR STERILIZATION CASES AND WERE RETURNED TO THE CASES AFTER VISUAL EXAMINATION. AFTER STERILIZATION, THE INSTRUMENTS WERE VISUALLY EXAMINED UNDER MAGNIFICATION AT 10 TO 20X WITH TUNGSTEN ILLUMINATION. NO VISUAL DEFECTS OR DAMAGE WAS DETECTED. THE CORNEAL SEPARATORS WERE THEN MEASURED TO NEW INSTRUMENT SPECIFICATIONS FOR 10730-X. ALL THE CORNEAL SEPARATORS MEASURED IN SPECIFICATION FOR OUTSIDE DIAMETER. THE CORNEAL SEPARATORS WERE EACH MEASURED FOR OUTSIDE DIAMETER, TIP RADIUS, BLADE CONCENTRICITY AND PLANARITY BOTH MEASURED WITHIN SPECIFICATION LIMITS.

    Description of Event or Problem · 1

    ON (B)(6) 2010, WHILE SURGEON (DR. (B)(6)) WAS CREATING THE SECOND CHANNEL WITH THE CCW DISSECTOR IN THE EYE, THE TIP OF THE DISSECTOR CAME UP THROUGH THE CORNEA. HE WAS ABLE TO INSERT THE SEGMENT AND THE PATIENT WAS GIVEN POST OP ANTIBIOTICS AND STEROIDS AS IS NORMAL. PATIENT WAS SENT HOME AND RETURNED FOR ONE DAY FOLLOW UP WITH IMPROVED VISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORNEAL SEPARATOR, CCW, 0.9MM CORNEA DISSECTOR, HNO HNO ADDITION TECHNOLOGY KV10730-2 3484900

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other