BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 3733023 · Received March 27, 2014

    Report

    Report Number
    3003288808-2014-00559
    Event Type
    Injury
    Date Received
    March 27, 2014
    Date of Event
    February 25, 2014
    Report Date
    February 28, 2014
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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. ADDITIONAL INFORMATION HAS BEEN REQUESTED. (B)(4).

    Description of Event or Problem · 1

    A TECHNICIAN REPORTED A CASE OF SUB-EPITHEAL INFILTRATES (SEI), OBSERVED ON A PT'S RIGHT EYE DURING ROUTINE TWO WEEK POSTOP FOLLOW UP LASIK TREATMENT REPORTER INDICATED TOPICAL STEROID DOSAGE WERE INCREASED, AND PT WAS RUBBING HER EYES WITHIN THE LAST FEW DAYS. PT NOTED NO FOREIGN BODY SENSATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179724 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention INTRALASE