BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 2963498 · Received February 13, 2013

    Report

    Report Number
    3003288808-2013-00043
    Event Type
    Injury
    Date Received
    February 13, 2013
    Date of Event
    March 18, 2012
    Report Date
    January 14, 2013
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 UNDERWENT LASIK. THE EVENING OF SURGERY, THE PATIENT SCRATCHED HIS EYE, WHICH RESULTED IN A CORNEAL ABRASION. A BANDAGE CONTACT LENS WAS INSERTED AND THE PATIENT WAS INSTRUCTED TO RETURN FOR A FOLLOW UP EXAM. FIVE DAYS LATER, THE PATIENT WAS DIAGNOSED WITH DLK (DIFFUSE LAMELLAR KERATITIS) AND A TOPICAL STEROID DROP WAS PRESCRIBED. THREE MONTHS LATER, THE PATIENT PRESENTED WITH EPITHELIAL INGROWTH, AND THE FLAP WAS LIFTED TO CLEAR THE INGROWTH. AFTER THAT, THE PATIENT HAD ANOTHER MILD CORNEAL EROSION THAT WAS TREATED AND HEALED. THE PATIENT WAS RELEASED FROM CARE ON (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63868 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