BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 2963497 · Received February 13, 2013

    Report

    Report Number
    3003288808-2013-00044
    Event Type
    Injury
    Date Received
    February 13, 2013
    Date of Event
    January 11, 2013
    Report Date
    January 14, 2013
    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

    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 IS STILL EXPERIENCING DRY EYES THREE MONTHS AFTER BILATERAL LASIK SURGERY. THE BCVA (BEST CORRECTED VISUAL ACUITY) IS REDUCED AT TIMES, BUT IT IS BELIEVED THAT THIS WILL IMPROVE WHEN THE DRYNESS IMPROVES. THE PATIENT IS BEING TREATED WITH ARTIFICIAL TEARS EVERY ONE TO TWO HOURS, CYCLOSPORINE EYE DROPS TWO TIMES PER DAY, STEROID EYE DROPS TWO TIMES PER DAY, AND AN ORAL ANTIBIOTIC ONCE PER DAY. THE PATIENT WILL BE EXAMINED AGAIN IN THREE WEEKS. THIS REPORT CONCERNS THE PATIENT'S RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62726 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention INTRALASE