BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 3223755 · Received July 10, 2013

    Report

    Report Number
    3003288808-2013-00407
    Event Type
    Injury
    Date Received
    July 10, 2013
    Date of Event
    June 11, 2013
    Report Date
    June 12, 2013
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008
    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. (B)(4).

    Description of Event or Problem · 1

    AN OPTOMETRIST REPORTED THAT A PATIENT WHO UNDERWENT LASIK WAS DIAGNOSED WITH ASYMPTOMATIC STAGE 1 DIFFUSE LAMELLAR KERATITIS (DLK) AT THE ONE DAY POSTOPERATIVE VISIT. THE TOPICAL STEROID DROPS WERE INCREASED, DLK RESOLVED WITH TREATMENT AND VISUAL ACUITY WAS NOT EFFECTED. THIS REPORT REFERENCES THE RIGHT EYE OF THE PATIENT. ADDITIONAL REPORT WILL BE FILED FOR THE LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316207 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention INTRALASE