BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVELIGHT EX500 EXCIMER LASER

    MDR report key: 8835983 · Received July 29, 2019

    Report

    Report Number
    3003288808-2019-00775
    Event Type
    Injury
    Date Received
    July 29, 2019
    Date of Event
    May 6, 2019
    Report Date
    November 14, 2019
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P020050
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE TECHNICAL SERVICE ONSITE HISTORY SHOWED NO ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THIS EVENT: LASER WAS SUCCESSFULLY VERIFIED PRIOR TO AND AFTER THE DAY OF TREATMENT. A REVIEW OF THE LOGFILE OF THE DAY OF TREATMENT COULD CONFIRM THAT THE USER TREATED THE PATIENT'S RIGHT EYE TWICE. FOR THE FIRST TREATMENT OF THE RIGHT EYE, THE SURGEON TREATED WITH PHOTOTHERAPEUTIC KERATOMETRY (PTK). FOR THE SECOND TREATMENT OF THE PATIENT'S RIGHT EYE, THE SURGEON TREATED WITH WAVEFRONT OPTIMIZED TREATMENT. NO ABNORMALITY COULD BE IDENTIFIED IN THE LOGFILE DESPITE THE REQUIRED ENERGY CHECK WAS NOT PERFORMED PRIOR TREATMENT SO A TECHNICAL ROOT CAUSE COULD BE EXCLUDED. CLINICAL APPLICATIONS SPECIALIST (CAS) REVIEW CONFIRMED THE USER PERFORMED A TWO-STEP TRANS-EPITHELIUM TREATMENT. THE EPITHELIUM WAS REMOVED WITH PTK AND THEN THE REFRACTIVE CORRECTION WAS PERFORMED WITH A PHOTOREFRACTIVE KERATECTOMY (PRK) PROCEDURE WHICH THE LASER DID NOT ADMIT. ACCORDING TO INFORMATION FROM CAS TEAM, PTK IS NOT DESIGNED FOR REFRACTIVE CORRECTION SO IF YOU PERFORM A PTK YOU ALWAYS HAVE TO EXPECT CHANGES IN REFRACTIVE OUTCOMES. THEREFORE, THE ROOT CAUSE OF THE REPORTED UNEXPECTED REFRACTIVE OUTCOME COULD NOT BE RELATED TO THE DEVICE BUT RATHER TO THE APPLIED TREATMENT MODE. THE REPORTED OUTCOME COMPLAINT CAN NOT BE VERIFIED BASED ON THE INSUFFICIENT CLINICAL DATA . NO TECHNICAL ROOT CAUSE WAS IDENTIFIED AS THE PRODUCT WAS FOUND TO BE WITHIN SPECIFICATIONS. THE ROOT CAUSE COULD NOT BE DETERMINED CONCLUSIVELY. THEY PERFORMED A TWO-STEP TRANS-EPITHELIUM TREATMENT WHICH COULD CAUSE AN UNEXPECTED REFRACTION OUTCOME. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 1

    INVESTIGATION, INCLUDING ROOT CAUSE ANALYSIS, IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. DEVICE HISTORY RECORD (DHR) FOR THE DEVICE REVIEWED. THE ASSOCIATED DEVICE WAS RELEASED BASED ON COMPANY¿S ACCEPTANCE CRITERIA. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    A DOCTOR REPORTED A PHOTO REFRACTIVE KERATECTOMY (PRK) PROCEDURE WAS PERFORMED USING PHOTOTHERAPEUTIC KERATECTOMY (PTK) PROFILE IN THE RIGHT EYE. EXCIMER LASER WAS USED TO REMOVE THE EPITHELIUM. TWO MONTHS POST-OPERATIVELY THE PATIENT RESULTED WITH HYPEROPIA. PATIENT WAS MYOPIC INITIALLY. DIFFERENCE IN OPTICAL ZONE WAS NOTED BETWEEN PTK PROFILE AND REFRACTIVE PROFILE. THERE ARE TWO RELATED REPORTS FOR THIS PATIENT. THIS REPORT ADDRESSES THE PATIENT'S RIGHT EYE AND ANOTHER MANUFACTURER REPORT WILL BE FILED FOR THE FELLOW EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629258 WAVELIGHT EX500 EXCIMER LASER OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other