BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISUMAX

    MDR report key: 19703854 · Received July 9, 2024

    Report

    Report Number
    9615030-2024-00013
    Event Type
    Injury
    Date Received
    July 9, 2024
    Date of Event
    January 11, 2024
    Report Date
    July 9, 2024
    Manufacturer
    CARL ZEISS MEDITEC AG (JENA)
    Product Code
    OTL
    PMA / PMN Number
    P150040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE VOLUNTARY REPORT DOES NOT IDENTIFY THE NAME OR THE CONTACT INFORMATION OF THE PATIENT OR THE DOCTOR. THEREFORE, THE RESPECTIVE DEVICE COULD NOT BE IDENTIFIED OR INVESTIGATED AND A ROOT CAUSE EVALUATION IS NOT POSSIBLE. THERE IS NO INDICATION THAT ANY MALFUNCTION OCCURRED DURING THE VISUMAX PROCEDURE WHICH COULD EXPLAIN THE MENTIONED SIDE EFFECTS.

    Description of Event or Problem · 0

    A VOLUNTARY REPORT (MW5155785) WAS SUBMITTED TO THE FDA BY A PATIENT IN THE US ON JUNE 4TH, 2024, THROUGH THE FDA'S MEDWATCH PROGRAM. THE PATIENT REPORTED: "I HAD RELEX SMILE SURGERY DONE ON MY LEFT EYE AND LASIK SURGERY DONE ON MY RIGHT EYE. I'VE HAD CONSTANT EYE PAIN IN MY LEFT EYE, FEELING OF THROBBING, STRAINING THAT THEN RADIATES ACROSS THE LEFT SIDE OF MY FACE. I'VE USED EYE DROPS CONSISTENTLY FOR MONTHS WITH NO CHANGES. ADDITIONALLY, I HAVE SEVERE GLARE AND SEVERE HALOS AT NIGHT MAKING DRIVING DIFFICULT AND SCARY. THE NEGATIVE OUTCOME OF THE SURGERY HAS LEAD ME TO A DEEP DEPRESSION, THOUGHTS OF SUICIDE AND INCREDIBLE STRAIN ON MY LIFE MAKING IT NEAR IMPOSSIBLE TO DO DAILY ACTIVITIES. MY SURGEON HAS DONE LITTLE TO NOTHING TO HELP FIND SOLUTIONS LEAVING ME TO LIVE IN AGONY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257325 VISUMAX FEMTOSECOND LASER SYSTEM FOR REFRACTIVE CORRECTION OTL CARL ZEISS MEDITEC AG (JENA) UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Male Disability| O "MAGNESIUMVITAMIN CXANAX - POST SURGERY"