BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISUMAX

    MDR report key: 19757494 · Received July 16, 2024

    Report

    Report Number
    9615030-2024-00014
    Event Type
    Malfunction
    Date Received
    July 16, 2024
    Date of Event
    June 18, 2024
    Report Date
    September 3, 2024
    Manufacturer
    CARL ZEISS MEDITEC AG (JENA)
    Product Code
    OTL
    UDI-DI
    04049471095036
    PMA / PMN Number
    P150040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DESCRIPTION OF CHANGES: FIELD A4: ADDED "PATIENT WEIGHT". FIELD B4: ADDED "DATE OF THIS REPORT" 8/26/2024. FIELD D4: CORRECTED UDI NUMBER. FIELD G3: UPDATED "DATE RECEIVED BY MANUFACTURER" TO "08/14/2024". FIELD G6: CHECKED "30 DAYS", UPDATED TO "FOLLOW-UP, # 1". FIELD H2: CHECKED "CORRECTION" AND "DEVICE EVALUATION". FIELD H4: CORRECTED DEVICE MANUFACTURE DATE. FIELD H6: UPDATED "INVESTIGATION FINDINGS" CODE "3243" AND UPDATED " INVESTIGATION CONCLUSION" TO "23". FIELD H11: ADDED DESCRIPTION OF CHANGES.

    Description of Event or Problem · 0

    DURING SURGERY, WHILE THE PATIENT WAS LYING ON THE PSS, THE Z-MOTOR BROKE CAUSING THE PSS TO FALL DOWN. WHEN THE INCIDENT HAPPENED THE SURGERY PROCESS HAD NOT START YET. THERE IS NO REPORT OF ANY NEGATIVE IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2508591 VISUMAX FEMTOSECOND LASER SYSTEM FOR REFRACTIVE CORRECTION OTL CARL ZEISS MEDITEC AG (JENA) 04049471095036

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown