BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISUMAX

    MDR report key: 24811483 · Received April 7, 2026

    Report

    Report Number
    9615030-2026-00017
    Event Type
    Injury
    Date Received
    April 7, 2026
    Date of Event
    March 6, 2026
    Report Date
    April 7, 2026
    Manufacturer
    CARL ZEISS MEDITEC AG (JENA)
    Product Code
    OTL
    UDI-DI
    04049471095036
    PMA / PMN Number
    P150040 S020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE AVAILABLE INFORMATION AND DEVICE EVALUATION THERE WAS NO DEVICE MALFUNCTION. IN ADDITION, THERE IS NO EVIDENCE TO INDICATE THE PRESENCE OF A POTENTIAL QUALITY ISSUE WITH RESPECT TO MANUFACTURING, DESIGN OR LABELING. THE ROOT CAUSE IS UNKNOWN. IT CAN BE ASSUMED THAT THE LIKELY ROOT CAUSE IS USER ERROR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING TREATMENT, FLAP WAS CREATED BUT IT APPEARED THAT THERE WAS NO HINGE WHEN LIFTED. CAP COMPLETELY CAME OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75550 VISUMAX FEMTOSECOND LASER SYSTEM FOR REFRACTIVE CORRECTION OTL CARL ZEISS MEDITEC AG (JENA) N/A N/A 04049471095036

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| D