BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 4100769 · Received September 12, 2014

    Report

    Report Number
    3003288808-2014-01389
    Event Type
    Injury
    Date Received
    September 12, 2014
    Date of Event
    July 30, 2014
    Report Date
    August 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
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO HAS BEEN REQUESTED. 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 INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    AN OPTOMETRIST REPORTED A PT WITH DRY EYE AND FOREIGN BODY SENSATION AT FIVE DAY LASIK POST-OPERATIVE VISIT. AT VISIT PT INDICATED SHE FELT A FOREIGN BODY IN HER EYES AND COMPLAINED OF DRY EYE. ADDITIONAL INFO HAS BEEN REQUESTED. THIS REPORT IS FOR THE LEFT EYE, AND ADDITIONAL REPORT WILL BE FILED FOR THE RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565233 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Other INTRALASE