BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISUMAX

    MDR report key: 11898121 · Received May 27, 2021

    Report

    Report Number
    9615030-2021-00009
    Event Type
    Injury
    Date Received
    May 27, 2021
    Report Date
    April 30, 2021
    Manufacturer
    CARL ZEISS MEDITEC AG (JENA)
    Product Code
    OTL
    PMA / PMN Number
    P150040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE TREATMENT WAS DONE 4 YEARS AGO. THE EXACT TIME IS NOT KNOWN. DETAILED PATIENT DATA IS NOT AVAILABLE. THE DESCRIBED CASE WAS NOT KNOWN TO THE MANUFACTURER BEFORE. A PATIENT CONTACTED THE MANUFACTURER CARL ZEISS MEDITEC (B)(4) (B)(4) TO COMPLAIN ABOUT A MISUSE OF VISUMAX DEVICE BY A DOCTOR. THE PATIENT WENT TO A CLINIC TO DO THE TESTS TO CORRECT THE EYESIGHT, AND IT WAS FOUND FROM TESTS THAT THE EYE CONDITION DOES NOT ALLOW SURGERY DUE TO THE PRESENCE OF A PROTRUSION ON THE SURFACE OF THE CORNEA AND ITS DEGREE OF DEGRADATION. IN SPITE OF THAT, THE DOCTOR DID THE SURGERY. IN THE MESSAGE TO THE MANUFACTURER, THE PATIENT MENTIONED A CORNEAL PROTRUSION WHICH IS A PATHOLOGY CALLED KERATOCONUS. KERATOCONUS IS A CONDITION WITH A RELATIVELY HIGH INCIDENCE IN (B)(6) AND AN ABSOLUTE CONTRAINDICATION FOR LASER REFRACTIVE SURGERY. THIS CONTRAINDICATION IS CLEARLY STATED IN THE VISUMAX USER MANUAL AND COMMON CLINICAL KNOWLEDGE. THE DESCRIBED WORSENING OF THE PATIENT'S MYOPIA WOULD SUPPORT THE ASSUMPTION OF A PRE-EXISTING KERATOCONUS. IT IS NECESSARY TO TREAT KERATOCONUS IN ORDER TO PREVENT ITS PROGRESSION AND TO PRESERVE VISUAL POTENTIAL.

    Description of Event or Problem · 1

    A PATIENT FROM (B)(6) CONTACTED THE MANUFACTURER CARL ZEISS MEDITEC (B)(4) (B)(4) TO COMPLAIN ABOUT A MISUSE OF VISUMAX DEVICE BY A DOCTOR. THE PATIENT WENT TO THE "(B)(6) CENTER AND (B)(6)" IN (B)(6) WHERE THE DOCTOR PERFORMED SMILE PROCEDURE ON HER EYES. THE PATIENT REPORTED THAT HER VISION WAS -3 PRE SURGERY. A WEEK AFTER THE SURGERY HER VISION DETERIORATED AND BECAME -4. AFTER TWO WEEKS, THE CORNEA BECAME IRREGULAR. THE PATIENT REPORTED THAT SHE FOUND OUT THAT HER EYE CONDITION DOES NOT ALLOW SMILE PROCEDURE DUE TO THE PRESENCE OF A PROTRUSION ON THE SURFACE OF THE CORNEA AND ITS DEGREE OF DEGRADATION. SUBSEQUENTLY, A DOCTOR PERFORMED AN ADDITIONAL PROCEDURE TO FIX THE PATIENT'S CORNEA, WHICH LED TO FURTHER DETERIORATION OF HER CONDITION. ACCORDING TO THE PATIENT, HER VISION DECREASED 3 TIMES, REACHING -7 IN THE RIGHT EYE AND -9 IN THE LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    794732 VISUMAX FEMTOSECOND LASER SYSTEM FOR REFRACTIVE CORRECTION OTL CARL ZEISS MEDITEC AG (JENA) N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability