BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 3934317 · Received June 27, 2014

    Report

    Report Number
    3003288808-2014-01030
    Event Type
    Injury
    Date Received
    June 27, 2014
    Date of Event
    May 23, 2014
    Report Date
    May 28, 2014
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 PT WITH EXTREME LIGHT SENSITIVITY AT ONE MONTH (PHOTOREFRACTIVE KERATECTOMY (PRK) POST-OPERATIVE VISIT. A VISIT PT COMPLAINT OF "EXTREME LIGHT SENSITIVITY, WEARS SUNGLASSES ON CLOUDY DAYS AND HAS TO DOUBLE UP SUNGLASSES ON SUNNY DAYS." ADDITIONAL INFO FROM REPORTED INDICATED PT'S TOPICAL STEROID DOSAGE WAS INCREASED AND THE REPORTED ISSUE RESOLVED AFTER ONE WEEK. THIS REPORT REFERENCES THE LEFT EYE. AN ADDITIONAL REPORT WILL BE FILED FOR THE RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378199 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYS LZS WAVELIGHT GMBH 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention