BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 3770941 · Received December 19, 2013

    Report

    Report Number
    3003288808-2013-00867
    Event Type
    Injury
    Date Received
    December 19, 2013
    Date of Event
    November 22, 2013
    Report Date
    November 22, 2013
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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. (B)(4).

    Description of Event or Problem · 1

    AN OPTOMETRIST REPORTED A PATIENT WITH STAGE ONE DIFFUSE LAMELLAR KERATITIS (DLK) INFERIOR AND SUPERIOR IN THE LEFT EYE, ONE DAY FOLLOWING LASIK TREATMENT. THE PATIENT'S TOPICAL STEROID DOSAGE WAS INCREASED. THE PATIENT REPORTED GOOD COMFORT AND VISION. IN A FOLLOW-UP WITH A TECHNICIAN, SHE INDICATED THE PATIENT WAS LAST SEEN ON (B)(6) 2013 AND THE DLK WAS RESOLVING BUT STILL PRESENT. THE PATIENT WAS RESCHEDULED TO RETURN THREE DAYS LATER BUT DID NOT SHOW UP FOR THE APPOINTMENT. IT WAS RESCHEDULED BUT THE PATIENT DID NOT SHOW AGAIN. THE PATIENT HAS NOT BEEN SINCE THE (B)(6) 2013 EXAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667031 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention INTRALASE