BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q EXCIMER LASER

    MDR report key: 5717083 · Received June 10, 2016

    Report

    Report Number
    3003288808-2016-01013
    Event Type
    Injury
    Date Received
    June 10, 2016
    Date of Event
    May 24, 2016
    Report Date
    August 5, 2016
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P020050
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    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. THE ASSOCIATED DEVICE WAS RELEASED BASED ON COMPANY ACCEPTANCE CRITERIA. (B)(4).

    Description of Event or Problem · 1

    UPON FOLLOW UP, VISION WAS REPORTED TO BE IMPROVED BUT IS STILL FLUCTUATING. PATIENT COMPLAINED OF SLIGHT BURNING AFTER WORK. THE PATIENT WAS ADVISED TO INCREASE ARTIFICIAL TEARS USAGE. PATIENT WAS USING ARTIFICIAL TEARS FOUR TIMES A DAY.

    Description of Event or Problem · 1

    AN OPTOMETRIST REPORTED A PATIENT COMPLAINING OF BLURRY AND FLUCTUATIONS IN THE VISION IN PATIENT'S RIGHT EYE 12 DAYS POST PHOTO REFRACTIVE KERATECTOMY (PRK). DRY EYES WAS REPORTED. 1-2+ PUNCTATE EPITHELIAL KERATITIS (PEK) WAS NOTED WHICH DOCTOR FELT WAS CONSISTENT WITH POST PRK NORMAL FINDINGS. PATIENT WAS REEDUCATED AND REASSURED REGARDING THE RECOVERY AND HEALING POST SURGERY. TOPICAL STEROID DOSAGE WAS INCREASED. 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
    372248 ALLEGRETTO WAVE EYE-Q EXCIMER LASER OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention