BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVELIGHT EX500 EXCIMER LASER

    MDR report key: 3934320 · Received June 27, 2014

    Report

    Report Number
    3003288808-2014-01039
    Event Type
    Injury
    Date Received
    June 27, 2014
    Report Date
    March 17, 2014
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    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 INFO BECOMES AVAILABLE. NO ADDITIONAL INFO IS EXPECTED FROM THE REPORTER. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED INFLAMMATION ON THE PT'S LEFT EYE AFTER UNEVENTFUL FEMTOSECOND LASIK SURGERY. INFLAMMATION WAS PERSISTING 15 MONTHS AFTER THE PROCEDURE WAS PERFORMED. A COMPANY REP REVIEWED THE PT'S FILE WITH THE REPORTER AND DESCRIBED THE INFLAMMATION AS VERY SMALL, MILD AND SIMILAR TO SCARRING. THE PT'S VISUAL ACUITY WAS NOT AFFECTED. ACCORDING TO THE SURGEON, THE INFLAMMATION WAS "MORE PATHOLOGICAL THAN RELATED TO SURGERY" AND HE DID NOT SUSPECT THE SYS. NO ADDITIONAL INFO IS EXPECTED FROM THE REPORTER. THIS IS ONE OF TWO MEDICAL DEVICE REPORTS BEING FILED FOR THIS PT. THIS REPORT IS FOR THE LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378200 WAVELIGHT EX500 EXCIMER LASER OPHTHALMIC EXCIMER LASER SYS LZS WAVELIGHT GMBH 8065990713 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other