BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISUMAX LASER KERATOME

    MDR report key: 8786762 · Received July 12, 2019

    Report

    Report Number
    9615030-2019-00010
    Event Type
    Injury
    Date Received
    July 12, 2019
    Date of Event
    July 3, 2018
    Report Date
    June 12, 2019
    Manufacturer
    CARL ZEISS MEDITEC AG (JENA)
    Product Code
    OTL
    PMA / PMN Number
    P150040
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE SIDE EFFECTS DESCRIBED BY THE PATIENT IS DOCUMENTED AS A POTENTIAL RISK OF THE SMILE PROCEDURE IN THE VISUMAX INSTRUCTION FOR USE. THE VOLUNTARY REPORT RECEIVED BY CZMI DOES NOT CONTAIN ANY PRODUCT INFORMATION SUCH AS SERIAL NUMBER OR CONTACT INFORMATION OF THE PATIENT, PHYSICIAN OR USER FACILITY. THEREFORE, THE MANUFACTURER IS UNABLE TO PERFORM A DETAILED INVESTIGATION OR CONFIRM THE ALLEGED INJURY.

    Description of Event or Problem · 1

    CARL ZEISS MEDITEC, INC. RECEIVED FROM THE FDA A VOLUNTARY EVENT REPORT MW5086919, WHICH WAS SUBMITTED BY A PATIENT. IN THE VOLUNTARY REPORT, THE PATIENT REPORTED EXPERIENCING VARIOUS SIDE EFFECTS POST REFRACTIVE CORRECTION SURGERY USING THE VISUMAX LASER SYSTEM. THE PATIENT DID NOT ALLEGE A DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578665 VISUMAX LASER KERATOME FEMTOSECOND LASER SYSTEM FOR REFRACTIVE CORRECTION OTL CARL ZEISS MEDITEC AG (JENA) NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other