BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 3122206 · Received May 17, 2013

    Report

    Report Number
    3003288808-2013-00269
    Event Type
    Injury
    Date Received
    May 17, 2013
    Date of Event
    March 29, 2013
    Report Date
    April 19, 2013
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Removal / Correction Number
    NA
    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 INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    AN OPTOMETRIST REPORTED THAT A PT WHO UNDERWENT PRK (PHOTO-REFRACTIVE KERATECTOMY) WHO HAD EBMD (EPITHELIAL BASEMENT MEMBRANE DYSTROPHY) PREOPERATIVELY, SHOWED TRACE CORNEAL HAZE AND LIGHT SENSITIVITY TWO WEEKS AFTER SURGERY. PT WAS TREATED WITH ADDITIONAL TOPICAL STEROID DROPS. UPON F/U, REPORTER STATED THAT THE HEALING STAGE WAS AS EXPECTED AND THIS EVENT IS NOT IN ANY WAY RELATED TO THE LASER. THE PT HAD EBMD PRESENT PRIOR TO TREATMENT. THIS REPORT REFERENCES THE PT'S LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219713 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention