BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 4100749 · Received September 12, 2014

    Report

    Report Number
    3003288808-2014-01380
    Event Type
    Injury
    Date Received
    September 12, 2014
    Date of Event
    August 13, 2014
    Report Date
    August 13, 2014
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 THAT A PATIENT WHO UNDERWENT BILATERAL LASIK WAS DIAGNOSED WITH DRY EYES, SEVEN MONTHS AFTER SURGERY. THE PATIENT REPORTED HER EYES FELT "TIRED" AND HAD BLURRED VISION IN BOTH EYES, WHICH DID NOT IMPROVE HER ARTIFICIAL TEARS. THE PATIENT WAS STARTED ON A NEW MEDICATION. IN A FOLLOW UP, THE OPTOMETRIST REPORTED THAT THE EYE DRYNESS IS ONGOING, AND IS EXPECTED TO CONTINUE TO IMPROVE WITH THE MEDICATION TREATMENT. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565266 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention INTRALASE