BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 2871541 · Received December 6, 2012

    Report

    Report Number
    3003288808-2012-00497
    Event Type
    Injury
    Date Received
    December 6, 2012
    Date of Event
    November 7, 2012
    Report Date
    November 7, 2012
    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 INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    AN OPTOMETRIST REPORTED A CASE OF TRACE DIFFUSE LAMELLAR KERATITIS (DLK), OBSERVED ON A LEFT EYE, ONE DAY POST BILATERAL LASIK SURGERY. REPORTER STATED THAT THE PT WAS ASYMPTOMATIC. STEROID DROPS FREQUENCY WAS INCREASED, TO TREAT THE REPORTED EVENT. UPON F/U, REPORTER STATED THAT THE DLK HAD CLEARED WITH TREATMENT, AND THE UNCORRECTED ACUITY WAS 20/20. THIS REPORT IS FOR THE PT'S LEFT EYE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention INTRALASE