BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVELIGHT EX500 EXCIMER LASER

    MDR report key: 10353850 · Received July 31, 2020

    Report

    Report Number
    3003288808-2020-00452
    Event Type
    Injury
    Date Received
    July 31, 2020
    Report Date
    August 20, 2020
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P020050
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON INFORMATION RECEIVED FOLLOWING SUBMISSION OF THE INITIAL REPORT, THIS EVENT DOES NOT MEET CRITERIA FOR REPORTING AS A SERIOUS INJURY. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED REPORTED THE CLINIC USED A MICROKERATOME WITH REUSABLE RINGS AND DISPOSABLE BLADES. PRIOR TO THE REPORTED EVENTS, DISPOSABLE RINGS AND BLADES WERE ROUTINELY USED. SINCE DISCONTINUING USE OF THE REUSABLE RINGS, THERE HAVE NOT BEEN ANY ADDITIONAL CASES OF CORNEAL OPACITY. THE EXCIMER DEVICE WAS ALSO FOUND TO BE WORKING AS INTENDED AND WITHIN SPECIFICATIONS.

    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 SURGEON REPORTED A PATIENT WITH A CORNEAL OPACITY THREE DAYS FOLLOWING LASIK TREATMENT OF THE LEFT EYE. THE PATIENT WAS PUT ON AN ANTIBIOTIC DROP, A STEROID DROP AND MOISTURIZING DROPS. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE MULTIPLE RELATED REPORTS FOR THIS EVENT. THIS REPORT ADDRESSES PATIENT KYE LEFT EYE, AND ADDITIONAL MANUFACTURER REPORTS WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    817305 WAVELIGHT EX500 EXCIMER LASER OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Required Intervention