BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVELIGHT EX500 EXCIMER LASER

    MDR report key: 5518154 · Received March 22, 2016

    Report

    Report Number
    3003288808-2016-00511
    Event Type
    Injury
    Date Received
    March 22, 2016
    Report Date
    June 24, 2016
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P020050
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION PROVIDED IN PT AND EVENT SECTIONS. CORRECTION: A SUPPLEMENTAL MEDICAL DEVICE REPORT (SMDR) #1 IS BEING FILED TO CORRECT THE DATE ON THE PRIOR FILED INITIAL REPORT. INCORRECT DATE OF 02/23/2016 IS BEING CORRECTED TO 03/18/2016. (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED. 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 DEVICE HISTORY RECORDS (DHR) FOR THE DEVICE WERE REVIEWED. THE ASSOCIATED DEVICE WAS RELEASED BASED ON COMPANY ACCEPTANCE CRITERIA. (B)(4).

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE TECHNICAL SERVICE ONSITE HISTORY SHOWED NO ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THIS EVENT: THE LASER WAS SUCCESSFULLY VERIFIED PRIOR TO AND AFTER THE DAY OF THE TREATMENT. WITH LIMITED INFORMATION THE ROOT CAUSE COULD NOT BE DETERMINED CONCLUSIVELY. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A PATIENT WITH ECTASIA AND IRREGULAR ASTIGMATISM OF THE RIGHT EYE POST LASIK TREATMENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. 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
    171755 WAVELIGHT EX500 EXCIMER LASER OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other