BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVELIGHT EX500 EXCIMER LASER

    MDR report key: 6144612 · Received December 5, 2016

    Report

    Report Number
    3003288808-2016-02154
    Event Type
    Injury
    Date Received
    December 5, 2016
    Date of Event
    August 16, 2016
    Report Date
    March 16, 2017
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P020050
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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 DEVICE HISTORY RECORDS (DHR) FOR THE DEVICE WAS REVIEWED. THE ASSOCIATED DEVICE WAS RELEASED BASED ON COMPANY ACCEPTANCE CRITERIA. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS (B)(4).

    Additional Manufacturer Narrative · 1

    THE SYSTEM HISTORY SHOWS THAT THE LASER WAS VERIFIED SUCCESSFULLY PRIOR TO AND AFTER THE DAY OF TREATMENT. LOG FILE FOR THE DATE OF TREATMENT SHOWS ALL LASER SYSTEM FUNCTIONS WERE WITHIN SPECIFICATIONS FOR THE RESPECTIVE TREATMENT. NO ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THIS EVENT WERE FOUND DURING DEVICE HISTORY REVIEW. NO TECHNICAL ROOT CAUSE WAS IDENTIFIED AS THE PRODUCT WAS FOUND TO BE WITHIN SPECIFICATIONS. THE ROOT CAUSE CANNOT BE DETERMINED CONCLUSIVELY. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED A PATIENT EXPERIENCED OVER CORRECTION GREATER THAN ONE DIOPTER APPROXIMATELY SIX WEEKS POST OPTIMIZED PHOTO REFRACTIVE KERATECTOMY (PRK) OF THE RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    796653 WAVELIGHT EX500 EXCIMER LASER OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other