BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q EXCIMER LASER

    MDR report key: 4636228 · Received March 26, 2015

    Report

    Report Number
    3003288808-2015-05124
    Event Type
    Injury
    Date Received
    March 26, 2015
    Date of Event
    February 9, 2015
    Report Date
    March 26, 2015
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P020050
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM HISTORY SHOWS THAT THE LASER WAS VERIFIED SUCCESSFULLY PRIOR TO THE DATE OF TREATMENT. LOGFILES REVIEW SHOWS THAT ALL TREATMENTS WERE COMPLETED TO 100% AND ALL LASER SYSTEM FUNCTIONS WERE WITHIN SPECIFICATIONS AT DAY OF TREATMENT. 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. THE TECHNICAL INVESTIGATION SHOWS THAT THE DEVICE MEETS THE SPECIFICATIONS. THE ROOT CAUSE CANNOT BE DETERMINED CONCLUSIVELY. (B)(4).

    Description of Event or Problem · 1

    AN OPTOMETRIST REPORTED A CASE OF BILATERAL TRACE PUNCTATE EPITHELIAL KERATITIS (PEK) AND DRY EYES AT ONE YEAR POST LASIK TREATMENT. PATIENT NOTED DECREASED VISION AT NIGHT. REPORTER INDICATED THE PATIENT HAS REFUSED ANY FURTHER FOLLOW UP CARE AT THEIR LOCATION AND NO RESOLUTION OF SYMPTOMS CAN BE ACCURATELY DETERMINED. UPON ADDITIONAL FOLLOW UP, REPORTER INDICATED THE PATIENT ISSUE HAS IMPROVED; HOWEVER STILL UNDERGOING TREATMENT WITH ANOTHER PROVIDER. THERE ARE TWO RELATED REPORTS FOR THIS PATIENT. THIS REPORT ADDRESSES THE PATIENT'S RIGHT EYE, AND ANOTHER MANUFACTURER REPORT WILL BE FILED FOR THE FELLOW EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201578 ALLEGRETTO WAVE EYE-Q EXCIMER LASER OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other INTRALASE