BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 3950670 · Received July 14, 2014

    Report

    Report Number
    3003288808-2014-01103
    Event Type
    Injury
    Date Received
    July 14, 2014
    Date of Event
    June 16, 2014
    Report Date
    June 16, 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

    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 CENTER DIRECTOR REPORTED A PATIENT WAS DIAGNOSED WITH DIFFUSE LAMELLAR KERATITIS (DLK) 3 DAYS FOLLOWING BILATERAL LASIK SURGERY. TOPICAL STEROID DOSAGE WAS INCREASED TO TREAT THIS EVENT. A COMPLETED QUESTIONNAIRE WAS RECEIVED, AND THE OPTOMETRIST REPORTED THE EVENT CONTINUES AND WILL RESOLVE WITH TREATMENT OF TOPICAL STEROIDS. IN HIS OPINION THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE EVENT. 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
    410045 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention INTRALASE