BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVELIGHT EX500 EXCIMER LASER

    MDR report key: 3030301 · Received March 28, 2013

    Report

    Report Number
    3003288808-2013-00130
    Event Type
    Injury
    Date Received
    March 28, 2013
    Date of Event
    February 22, 2013
    Report Date
    February 28, 2013
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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 INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED, PATIENT WITH BILATERAL CENTRAL TOXIC KERATOPATHY, AND LOSS OF BCVA, NOTED AFTER BILATERAL PHOTO REFRACTIVE KERATECTOMY. THE PATIENT WAS TREATED WITH ANTI-INFLAMMATORY DROPS AND ARTIFICIAL TEARS. AT FOUR WEEKS POST OP, THE CTK (CENTRAL TOXIC KERATOPATHY) HAD RESOLVED WITH TREATMENT AND NO FURTHER MEDICAL TREATMENT WAS REQUIRED. THE VISION ALSO IMPROVED. NO FURTHER INFORMATION WILL BE EXPECTED FOR THIS CASE. THIS REPORT WILL ADDRESS THE RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127546 WAVELIGHT EX500 EXCIMER LASER OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990713 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention