BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 3111336 · Received May 9, 2013

    Report

    Report Number
    3003288808-2013-00233
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 17, 2013
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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

    A SURGEON REPORTED TWO PATIENT CASES OF BILATERAL CENTRAL ISLAND NOTED AFTER PRK (PHOTO REFRACTIVE KERATECTOMY). A COMPANY CLINICAL APPLICATIONS REPRESENTATIVE FOLLOWED UP WITH THE SURGEON, AND AFTER DISCUSSION IT WAS NOTED THAT THE "APPEARANCE ON THE TOPOGRAPHIES IS CAUSED BY THE CORNEAL HEALING AND THEREFORE INCREASED SCATTERING." ALSO NOTED WAS THAT IN THESE REPORTS "THE CENTRAL ISLAND IS AN ARTIFACT, MOST LIKELY CAUSED BY EPITHELIAL HYPERPLASIA." THE PATIENT'S VISION WAS NOTED AS CONTINUING TO IMPROVE. IT WAS CONCLUDED, DURING THE DISCUSSION, THAT THIS IS NOT A LASER RELATED ISSUE BUT AN ISSUE RELATED TO THE HEALING REACTION OF THE EPITHELIAL CELLS OF THE CORNEA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204688 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other