BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EY-Q

    MDR report key: 3678857 · Received February 14, 2014

    Report

    Report Number
    3003288808-2014-00249
    Event Type
    Injury
    Date Received
    February 14, 2014
    Date of Event
    January 14, 2014
    Report Date
    January 14, 2014
    Manufacturer
    WAFELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 ADD'L REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A CENTRAL DIRECTOR REPORTED THAT SIX DAYS FOLLOWING BILATERAL PRK (PHOTOREFRACTIVE KERATECTOMY) PROCEDURE, THE PT PRESENTED WITH SUBEPITHELIAL CORNEAL EDEMA IN THE RIGHT EYE ONLY, AFTER THE BANDAGE CONTACT LENS WAS REMOVED. THE PT REPORTED SOME SLIGHT DISCOMFORT AND WAS TREATED WITH EYEDROPS. IN A F/U, THE CENTER DIRECTOR REPORTED THAT THE EVENT RESOLVED WITH THE TREATMENT, TWO WEEKS LATER, AND THE PT HAD NO ISSUES TO REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98085 ALLEGRETTO WAVE EY-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAFELIGHT GMBH 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention PRK MICROKERATOME