BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVELIGHT FS200 FEMTOSECOND LASER

    MDR report key: 11630995 · Received April 7, 2021

    Report

    Report Number
    3003288808-2021-00187
    Event Type
    Injury
    Date Received
    April 7, 2021
    Date of Event
    March 23, 2021
    Report Date
    August 10, 2021
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    OOE
    PMA / PMN Number
    K141476
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD WAS TRACEABLE TO THE REPORTED SERIAL NUMBER INDICATING THAT THE PRODUCT WAS PROCESSED AND RELEASED ACCORDING TO THE PRODUCT¿S ACCEPTANCE CRITERIA. A REVIEW OF THE TECHNICAL SERVICE ONSITE HISTORY SHOWED NO ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THIS EVENT: LASER WAS SUCCESSFULLY VERIFIED PRIOR TO THE DAY OF THE TREATMENT. THE REVIEW OF LOGFILE FOR THE DAY OF TREATMENT SHOWED ALL LASER SYSTEM FUNCTIONS WERE WITHIN SPECIFICATIONS. DURING START-UP OF THE SYSTEM, THE VACUUM, THE ENERGY AND THE ABLATION TESTS WERE PERFORMED WITHOUT ANY ISSUE. ENERGY CHECK WAS NOT PERFORMED AS RECOMMENDED EVERY TWO HOURS. THE LOGFILE SHOWED MULTIPLE SUCCESSFULLY PERFORMED TREATMENTS. THE REPORTED TREATMENT COULD BE IDENTIFIED IN THE LOGFILE. NO RELEVANT DEVIATION BETWEEN PLANNED AND PERFORMED ENERGY WAS DETECTABLE FOR THE REPORTED TREATMENT. LOGFILE SHOWED THAT THE BEAM CONTROL CHECK FOR THE LEFT EYE WAS DONE SEVERAL MINUTES BEFORE THE LASER FIRED INSTEAD OF IMMEDIATELY BEFORE FIRING. TREATMENT FOR LEFT EYE WAS FINISHED SUCCESSFULLY WITHOUT ANY ISSUE. THE THICKNESS OF THE FLAP WAS THINNER THAN THE RECOMMENDED FLAP THICKNESS. THE USER OPERATED SURGERY WITHIN THE RECOMMENDED ENERGY SETTINGS. NO TECHNICAL ROOT CAUSE COULD BE IDENTIFIED. ACCORDING TO THE INITIAL REPORT, AS THE FLAP WAS BEING MADE (SEEN IN THE TREATMENT DOCUMENT), THERE WAS A DEFINITIVE LINE SEEN IN THE CANAL WHERE THE FLAP WAS NOT ABLE TO VENT AND AS THE BED WAS BEING MADE THE GAS WAS NOT ABLE TO MOVE AND CREATED THIS WHITE/TOUGH AREA. THE PHYSICIAN FELT IT WAS LIKELY THE PATIENT'S ANATOMY. THE TREATMENT REPORT SHOWED POSSIBLE OPAQUE BUBBLE LAYER. NO TECHNICAL ROOT CAUSE COULD BE DETERMINED FOR THE REPORTED EVENT. WITH CURRENT INFORMATION, A DEVICE MALFUNCTION COULD BE EXCLUDED. POSSIBLE CONTRIBUTING FACTORS FOR INCOMPLETE FLAP COULD BE MOVEMENT OF THE PATIENT, IMPROPER DOCKING, AND/OR TOO MUCH FLUID ON THE EYE. 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. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    A PHYSICIAN REPORTED A WHITE TOUGH AREA APPEARED CLOSE TO THE HINGE (ABOUT SEVEN O'CLOCK) DURING FLAP CREATION. THE DOCTOR WAS ABLE TO GET THE MAJORITY OF THE AREA SEPARATED BY USING A FLAP LIFTER. A BLADE WAS USED TO FINISH SEPARATING. TREATMENT WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    525132 WAVELIGHT FS200 FEMTOSECOND LASER OPHTHALMIC LASER OOE WAVELIGHT GMBH NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention