BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q EXCIMER LASER

    MDR report key: 6680977 · Received June 30, 2017

    Report

    Report Number
    3003288808-2017-01512
    Event Type
    Injury
    Date Received
    June 30, 2017
    Date of Event
    June 5, 2017
    Report Date
    August 23, 2017
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P020050
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE TECHNICAL SERVICE ONSITE HISTORY SHOWED NO ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THIS EVENT: THE LASER WAS SUCCESSFULLY VERIFIED PRIOR TO AND AFTER THE TREATMENT. NO TECHNICAL ROOT CAUSE WAS IDENTIFIED AS THE PRODUCT WAS FOUND TO BE WITHIN SPECIFICATIONS. (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¿S ACCEPTANCE CRITERIA. NO UDI REQUIRED DUE TO THIS DEVICE WAS OUT OF PRODUCTION PRIOR TO THE SEPTEMBER 24, 2014 UDI REGULATION DATE. (B)(4).

    Description of Event or Problem · 1

    AN OPTOMETRIST REPORTED A POTENTIAL VIRAL INFECTION (EPIDEMIC KERATOCONJUNCTIVITIS - EKC) ONE WEEK POST LASIK IN A PATIENT'S LEFT EYE. THE PATIENT COMPLAINS OF BLURRY VISION AND WHITE SPOTS ON THE LEFT EYE. UPON FOLLOW UP, THE PATIENT IS BEING REFERRED TO A CORNEA SPECIALIST. UPON ADDITIONAL INFORMATION, THE SURGEON WAS NOT COMFORTABLE WITH THE EKC DIAGNOSIS AND WANTED CORNEAL CULTURES. THE PATIENT SAW A CORNEAL SPECIALIST IMMEDIATELY AND WAS GRAM POSITIVE STAINED. THE CORNEAL BED WAS RINSED OFF AND THE FLAP WAS REPLACED. THE SPECIALIST DIAGNOSED THE PATIENT WITH A FLAP INTERFACE INFECTION. PATIENT WAS STARTED ON 2 TOPICAL ANTIBIOTICS AND AN ORAL ANTIBIOTIC FOR 3 DAYS. GRAM STAIN CAME BACK AS COCCI POSITIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463076 ALLEGRETTO WAVE EYE-Q EXCIMER LASER OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Other