BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 3111351 · Received May 9, 2013

    Report

    Report Number
    3003288808-2013-00234
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 12, 2013
    Report Date
    April 15, 2013
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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

    AN OPTOMETRIST REPORTED THAT AT ONE DAY POST OP LASIK SURGERY, A PATIENT PRESENTED WITH BILATERAL STAGE ONE DIFFUSE LAMELLAR KERATITIS (DLK) AND STAPH MARGINAL KERATITIS. REPORT INCLUDED PATIENT COMMENT OF EYES BEING 'MILDLY SCRATCHY BUT SEEING BETTER THAN BEFORE.' AT ONE WEEK POST OP THE PATIENT'S STATUS HAD IMPROVED, DID NOT REQUIRE MEDICAL INTERVENTION, AND THE VISION WAS 20/20. NO ADDITIONAL INFORMATION IS EXPECTED FOR THIS CASE. THIS REPORT WILL ADDRESS THE PATIENT'S LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204692 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other INTRALASE