BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 3890761 · Received June 11, 2014

    Report

    Report Number
    3003288808-2014-00968
    Event Type
    Injury
    Date Received
    June 11, 2014
    Date of Event
    May 10, 2014
    Report Date
    May 13, 2014
    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 ONE DAY FOLLOWING PHOTO REFRACTIVE KERATECTOMY (PRK), THE PATIENT PRESENTED WITH STAPH MARGINAL KERATITIS IN THE LEFT EYE. THE PATIENT REPORTED MILD IRRITATION. THE TOPICAL STEROID DROPS WERE INCREASED. ADDITIONAL INFORMATION RECEIVED FROM THE OPTOMETRIST INDICATED THAT THE PATIENT WAS TREATED WITH MEDICATION, AND THE EVENT RESOLVED AFTER TWELVE DAYS. IN THE OPTOMETRIST'S OPINION, IT IS UNLIKELY THAT THE DEVICE CONTRIBUTED TO THE EVENT. NO FURTHER INFORMATION IS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345322 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention PREDNILSOLONE| ACUVAIL| ZYMAXID