BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISUMAX LASER KERATOME

    MDR report key: 8029291 · Received November 1, 2018

    Report

    Report Number
    9615030-2018-00010
    Event Type
    Injury
    Date Received
    November 1, 2018
    Date of Event
    October 3, 2018
    Report Date
    October 3, 2018
    Manufacturer
    CARL ZEISS MEDITEC AG (JENA)
    Product Code
    OTL
    PMA / PMN Number
    P150040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON REVIEW OF SYSTEM LOG FILES AND THE VIDEOS CAPTURED FROM EACH OF THE SURGERIES PERFORMED, THE VISUMAX DEVICE WORKED ACCORDING TO SPECIFICATIONS. AS REPORTED BY THE HCP, THE ISSUE WITH THE PATIENT'S VISION WAS A DUE TO THE OTHER HCP'S ACTION (I.E. CREATION OF A "THIRD CUT") WHILE REMOVING THE LENTICULE DURING THE SMILE SURGERY. A DEVICE EVALUATION WAS NOT PERFORMED SINCE THERE WAS NO ALLEGATION OF A DEVICE MALFUNCTION.

    Description of Event or Problem · 1

    ON (B)(6) 2018, A HEALTHCARE PROFESSIONAL (HCP) INITIATED A CIRCLE SURGERY TO IMPROVE THE VISUAL ACUITY OF A PATIENT THAT PREVIOUSLY UNDERWENT A SMILE SURGERY PERFORMED BY A DIFFERENT HCP FROM THE SAME FACILITY WITH THE SAME VISUMAX DEVICE. PRIOR TO THE CIRCLE SURGERY, IT WAS REPORTED THAT THE PATIENT HAD A VISUAL ACUITY OF 8/10 WITH REFRACTION ON THE RIGHT EYE (OD) THAT CANNOT BE IMPROVED WITH CORRECTION. DURING THE CIRCLE SURGERY, AFTER HAVING CREATED THE CIRCLE CUT AND DURING THE REMOVAL OF THE FLAP, THE SURGEON FOUND THAT THE CORNEAL STROMA ON THE VISUAL AXIS HAD BEEN DAMAGED DURING THE SMILE SURGERY (BY CREATION OF A "THIRD CUT") BY THE OTHER HCP FROM THE SAME FACILITY. THEREFORE, THE HCP DECIDED TO STOP THE CIRCLE SURGERY. TWO DAYS AFTER THE CIRCLE SURGERY, THE PATIENT'S VISUAL ACUITY WAS CHECKED BY THE HCP AND REPORTED TO BE 5/10. THE HCP REPORTED THAT HE PLANS TO SEE THE PATIENT AGAIN IN A MONTH TO GENERATE TOPOGRAPHY IMAGES, AND PERFORM TOMOGRAPHY SCANS AND A SLIT LAMP EXAM. NO FURTHER DETAILS ARE KNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    869695 VISUMAX LASER KERATOME FEMTOSECOND LASER SYSTEM FOR REFRACTIVE CORRECTION OTL CARL ZEISS MEDITEC AG (JENA) NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other