BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 3122071 · Received May 16, 2013

    Report

    Report Number
    3003288808-2013-00257
    Event Type
    Injury
    Date Received
    May 16, 2013
    Date of Event
    April 16, 2013
    Report Date
    April 16, 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 BILATERAL LASIK WAS DIAGNOSED WITH TRACE DIFFUSE LAMELLAR KERATITIS (DLK), AT THE ONE DAY POST-OP VISIT. REPORTER STATED THAT PATIENT WAS TREATED WITH INCREASED STEROID DROPS, FOLLOWED BY A TAPER. UPON FOLLOW UP, REPORTER INFORMED THAT THE DLK RESOLVED WITH TREATMENT, AND PATIENT'S POST-OP UNCORRECTED ACUITY IS 20/15. THIS REPORT WILL REFERENCE THE PATIENT'S RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    217185 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention INTRALASE