BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 3890861 · Received June 11, 2014

    Report

    Report Number
    3003288808-2014-00959
    Event Type
    Injury
    Date Received
    June 11, 2014
    Date of Event
    May 16, 2014
    Report Date
    May 16, 2014
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: 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. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION. A COMPLETED QUESTIONNAIRE WAS RECEIVED. (B)(4). THIS REPORT WAS MAILED TO FDA ON: 06/13/2014. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    A TECHNICIAN REPORTED A PATIENT WAS DIAGNOSED WITH DIFFUSE LAMELLAR KERATITIS (DLK) ONE DAY POST LASIK SURGERY, THE PATIENT WAS ASYMPTOMATIC TOPICAL STEROID DOSAGE WAS INCREASED TO TREAT THE EVENT, WHICH RESOLVED IN 24 HOURS. ADDITIONAL INFORMATION WAS RECEIVED WHICH THE OPTOMETRIST INDICATED THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE EVENT. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345380 ALLEGRETTO WAVE EYE-Q OPTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention INTRALASE