BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 2980647 · Received February 21, 2013

    Report

    Report Number
    3003288808-2013-00059
    Event Type
    Injury
    Date Received
    February 21, 2013
    Date of Event
    August 2, 2012
    Report Date
    January 25, 2013
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 THE FOLLOWING: A PATIENT HAD PRESENTED AT THE PRE-LASIK EVALUATION WITH DRY EYES, VARIABLE REFRACTION, AND VARIABLE VISION. SHE WAS STARTED ON TOPICAL CYCLOSPORINE DROPS AND HAD TWO APPOINTMENTS ((B)(6) 2012) TO RECHECK HER REFRACTION AND TEAR FILM. SHE DEMONSTRATED NO OBJECTIVE SIGNS OF DRYNESS ON (B)(6) 2012. THE PATIENT WAS ADVISED ABOUT POSTOPERATIVE DRY EYE RISKS AND EXPECTATIONS. THE LASIK WAS PERFORMED ON (B)(6) 2012. ON (B)(6) 2012 THE PATIENT REPORTED DRY EYES WITH VISUAL FLUCTUATION. THERE ARE NO OBJECTIVE SIGNS OF DRY EYE (NO STAINING, TBUT (TEAR BREAK UP TIME) IS NORMAL, SCHIRMER TEST IS NORMAL). THE PATIENT CONTINUES TO USE TOPICAL CYCLOSPORINE DROPS AND ARTIFICIAL TEARS. SHE IS ALSO UNDER THE CARE OF A SECOND OPHTHALMOLOGIST, FROM WHOM SHE HAS SOUGHT AN ADDITIONAL OPINION. THIS REPORT CONCERNS THE PATIENT'S RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75323 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other INTRALASE