BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISUMAX LASER KERATOME

    MDR report key: 7866702 · Received September 11, 2018

    Report

    Report Number
    9615030-2018-00005
    Event Type
    Injury
    Date Received
    September 11, 2018
    Date of Event
    May 18, 2018
    Report Date
    August 13, 2018
    Manufacturer
    CARL ZEISS MEDITEC AG (JENA)
    Product Code
    OTL
    PMA / PMN Number
    P150040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE AVAILABLE INFORMATION WAS REVIEWED AND NO MATCHING COMPLAINT WAS IDENTIFIED WITH THE EVENT REPORTED ON THE VOLUNTARY EVENT REPORT MW5078745. NO ADDITIONAL INFORMATION ABOUT PATIENT, DEVICE, OR HEALTH CARE PROFESSIONAL (HCP) COULD BE OBTAINED FROM THE VOLUNTARY EVENT REPORT OR THE MAUDE DATABASE. XEROPHTHALMIA OR DRY EYE IS DOCUMENTED AS A POTENTIAL RISK OF THE SMILE PROCEDURE IN THE VISUMAX INSTRUCTION FOR USE.

    Description of Event or Problem · 1

    CARL ZEISS MEDITEC, INC. RECEIVED FROM THE FDA A VOLUNTARY EVENT REPORT MW5078745, WHICH WAS SUBMITTED BY A HEALTH CARE PROFESSIONAL (HCP). IN THE VOLUNTARY REPORT, THE HCP REPORTED THAT A PATIENT EXPERIENCED SEVERE XEROPHTHALMIA POST REFRACTIVE CORRECTION SURGERY USING THE VISUMAX LASER SYSTEM. THE PHYSICIAN DID NOT ALLEGE A DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708366 VISUMAX LASER KERATOME FEMTOSECOND LASER SYSTEM FOR REFRACTIVE CORRECTION OTL CARL ZEISS MEDITEC AG (JENA) NI N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other