BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 3820745 · Received May 7, 2014

    Report

    Report Number
    3003288808-2014-00788
    Event Type
    Injury
    Date Received
    May 7, 2014
    Date of Event
    April 9, 2014
    Report Date
    April 9, 2014
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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. THE DEVICE HISTORY RECORDS (DHR) FOR THE DEVICE WAS REVIEWED. NO ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THIS EVENT WERE FOUND. THE ASSOCIATED DEVICE WAS RELEASED BASED ON COMPANY ACCEPTANCE CRITERIA. (B)(4).

    Description of Event or Problem · 1

    AN OPTOMETRIST REPORTED A CASE OF BILATERAL CORNEAL ABRASION, OBSERVED AT TWO WEEKS POST LASIK TREATMENT. REPORTER INDICATED TRANSIENT LIGHT SENSITIVITY SYNDROME AND CORNEAL ABRASION CAUSING VISION TO BLUR TRANSIENTLY, LACK OF SLEEP, AND NO IMPROVEMENT WITH DROPS. PATIENT NOTED DRY EYES AND BLURRED DISTANCE VISION. UPON FOLLOW UP, REPORTER INDICATED THE PATIENT DISPLAYED SUBCLINICAL EPITHELIAL BASEMENT MEMBRANE DYSTROPHY (EBMD), WHICH WAS NOTED TO HAVE NOT BEEN DETECTABLE UNDER THE SLIT LAMP EXAM PRE-OPERATIVELY. THERE ARE TWO RELATED REPORTS FOR THIS PATIENT. THIS REPORT ADDRESSES THE LEFT EYE, AND ANOTHER MANUFACTURER REPORT WILL BE FILED FOR THE FELLOW EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276712 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Other INTRALASE