BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 3896230 · Received June 13, 2014

    Report

    Report Number
    3003288808-2014-00974
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    May 15, 2014
    Report Date
    May 15, 2014
    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 ADD'L REPORTABLE INFO BECOMES AVAILABLE. THE DEVICE HISTORY RECORDS (DHR) FOR THE DEVICE WAS REVIEWED. THE ASSOCIATED DEVICE WAS RELEASED BASED ON COMPANY ACCEPTANCE CRITERIA. (B)(4).

    Description of Event or Problem · 1

    AN OPTOMETRIST REPORTED A CASE OF BILATERAL LIGHT SENSITIVITY, OBSERVED AT THREE WEEKS POST LASIK TREATMENT. REPORTER INDICATED TOPICAL STEROID EYE DROP DOSAGE WAS INCREASED. PT NOTED LIGHT FELT LIKE IT WAS BURNING HIS EYES AND BOTH EYES WERE SENSITIVE TO LIGHT, ALSO WAS TEARING A LOT, BUT VISION NOT AFFECTED. UPON FOLLOW UP, REPORTER INDICATED THAT TRACE CORNEAL EDEMA WAS OBSERVED IN BOTH EYES POST OPERATIVE. UPON ADD'L FOLLOW UP, REPORTER INDICATED PT ISSUE WAS RESOLVED. THERE ARE TWO RELATED REPORTS FOR THIS PT. THIS REPORT ADDRESSES THE PT'S RIGHT EYE, AND ANOTHER MFR REPORT WILL BE FILED FOR THE FELLOW EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351165 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention INTRALASE