BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISUMAX LASER KERATOME

    MDR report key: 3902834 · Received February 20, 2014

    Report

    Report Number
    9615030-2014-00001
    Event Type
    Malfunction
    Date Received
    February 20, 2014
    Date of Event
    January 20, 2014
    Report Date
    February 20, 2014
    Manufacturer
    CARL ZEISS MEDITEC AG
    Product Code
    HQF
    PMA / PMN Number
    K100253
    Removal / Correction Number
    9615030-02-04-14-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A SUBSET OF A LOT OF VISUMAX TREATMENT PACKS LABELED SIZE M (MEDIUM) CONTAINED AN S (SMALL) SIZED CONTACT LENS. THIS MISMATCH MAY LEAD TO INCOMPLETE TISSUE DISSECTION AT THE PERIPHERY (I.E. THE CIRCUMFERENTIAL OPENING CUTS THAT REACH THE ANTERIOR SURFACE OF THE CORNEA MIGHT NOT BE CREATED) LEADING TO A NON-LIFTABLE FLAP. THE SURGEON MADE THE DECISION TO REPEAT THE FLAP CUTTING MULTIPLE TIMES OVER TWO DAYS INSTEAD OF WAITING FOR SEVERAL MONTHS BEFORE REPEATING THE PROCEDURE. INFO REGARDING POST-OPERATIVE FOLLOW-UP WITH THE PT IS PENDING. (B)(4)

    Description of Event or Problem · 1

    DURING A BI-LATERAL FLAP PROCEDURE USING THE VISUMAX LASER KERATOME SYSTEM, THE SURGEON FOUND THAT THE PT'S LEFT EYE HAD A NON-LIFTABLE FLAP. THE SURGEON REPEATED THE COMPLETE FLAP PROCEDURE THREE TIMES OVER A PERIOD OF ABOUT 25 MINUTES ON THE PT'S LEFT EYE WITH SIMILAR RESULT. THE SURGEON SCHEDULED A FOLLOW-UP SURGERY FOR THE NEXT DAY. A FLAP CUT WAS PERFORMED WITHOUT AN EYE, INTERRUPTED ACTIVELY AND THEN THE EYE WAS TREATED WITH THE "REMAINING" SIDE-CUT. THE FLAP WAS STILL HARD TO OPEN AND THE SURGEON USED SCISSORS TO OPEN THE FLAP. REFRACTIVE SURGERY USING EXCIMER LASER ABLATION FOLLOWED FLAP OPENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107755 VISUMAX LASER KERATOME MICROSCOPE, SURGICAL, GENERAL & PLA HQF CARL ZEISS MEDITEC AG VISUMAX NA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR