BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 3940344 · Received June 26, 2014

    Report

    Report Number
    3003288808-2014-01037
    Event Type
    Injury
    Date Received
    June 26, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 2, 2014
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P03008
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    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. THE DEVICE HISTORY RECORD (DHR) FOR THE DEVICE WAS REVIEWED. THE ASSOCIATED DEVICE WAS RELEASED BASED ON COMPANY ACCEPTANCE CRITERIA. (B)(4).

    Description of Event or Problem · 1

    AN OPTOMETRIST REPORTED A CASE OF BILATERAL STAGE TWO DIFFUSE LAMELLAR KERATITIS (DLK) NOTED AT TWO DAY POST LASIK TREATMENT. REPORTER INDICATED PATIENT BECAUSE CONFUSED ABOUT EYE DROP DOSAGE BETWEEN ANTI-INFLAMMATORY AND STEROID. REPORTER RELAYED PATIENT WAS SEEN AGAIN AT ELEVEN DAYS POST OP, AFTER USING DROPS CORRECTLY, AND PATIENT ISSUE HAS IMPROVED TO STAGE ONE. A BANDAGE SOFT CONTACT LENS WAS INSERTED TO STABILIZE EPITHELIUM. PATIENT NOTED HALOS AND GLARE. UPON ADDITIONAL FOLLOW UP, REPORTER INDICATED THE PATIENT WAS ALSO PLACED ON AN ANTIFUNGAL EYE DROP AND IS IMPROVING, BUT CONTINUING TO BE MONITORED. THERE ARE TWO RELATED REPORTS FOR THIS PATIENT. THIS REPORT ADDRESSES THE PATIENT'S RIGHT EYE, AND ANOTHER MANUFACTURER REPORT WILL BE FILED FOR THE FELLOW EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373419 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention INTRALASE