BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 4121279 · Received September 22, 2014

    Report

    Report Number
    3003288808-2014-01428
    Event Type
    Injury
    Date Received
    September 22, 2014
    Date of Event
    August 30, 2014
    Report Date
    August 30, 2014
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS (DHR) FOR THE DEVICE WERE REVIEWED. THE ASSOCIATED DEVICE WAS RELEASED BASED ON ACCEPTANCE CRITERIA. 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 TECHNICIAN REPORTED THAT A PATIENT PRESENTED WITH STAGE TWO DIFFUSE LAMELLAR KERATITIS (DLK), ONE DAY FOLLOWING LASIK SURGERY. AN ORAL STEROID WAS PRESCRIBED AND TOPICAL STEROID DOSAGE WAS INCREASED TO TREAT THE EVENT. THE PATIENT REPORTED HIS EYES FELT SCRATCHY. IN A FOLLOW UP, THE TECHNICIAN REPORTED THE EVENT HAD RESOLVED. NO FURTHER INFORMATION IS EXPECTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587524 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention INTRALASE