BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 4101721 · Received September 15, 2014

    Report

    Report Number
    3003288808-2014-01394
    Event Type
    Injury
    Date Received
    September 15, 2014
    Date of Event
    July 14, 2014
    Report Date
    August 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
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 TWO MONTHS FOLLOWING BILATERAL LASIK SURGERY, THE PATIENT PRESENTED WITH LIGHT SENSITIVITY IN BOTH EYES. IN A FOLLOW UP, THE OPTOMETRIST REPORTED THAT THE EVENT CONTINUED, AND THE PATIENT WAS TREATED WITH EYE MEDICATION. PER THE OPTOMETRIST, IN THE OPINION OF THE SURGEON, IT WAS UNLIKELY THAT THE LASER CAUSED OR CONTRIBUTED TO THE EVENT. 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
    569799 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention INTRALASE