BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 3912604 · Received June 13, 2014

    Report

    Report Number
    3003288808-2014-00969
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    October 19, 2013
    Report Date
    May 14, 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

    THE DEVICE HISTORY RECORDS (DHR) FOR THE DEVICE WAS REVIEWED AND THERE WERE NO UNUSUAL FINDINGS RELATED TO THE REPORTED ISSUE AND THE PRODUCT WAS RELEASED ACCORDING TO COMPANY ACCEPTABLE CRITERIA. A REVIEW OF THE TECHNICAL SERVICE ON-SITE SHOWED NO ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THIS EVENT; LASER WAS SUCCESSFULLY VERIFIED PRIOR AND AFTER THE DAY OF THE EVENT. LOGFILE REVIEW SHOWS NO ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO REPORTED EVENT. THE TREATMENTS WERE COMPLETED TO 100% AND ALL LASER SYSTEM FUNCTIONS WERE WITHIN SPECIFICATIONS AT THIS DAY. THE ROOT CAUSE COULD NOT BE DETERMINED CONCLUSIVELY, AS THE SYSTEM WAS WORKING NORMALLY. (B)(4).

    Description of Event or Problem · 1

    AN OPTOMETRIST REPORTED PATIENT WITH INFLAMMATION OF THE LEFT EYE AT ONE DAY PHOTOREFRACTIVE KERATECTOMY (PRK) POST-OPERATIVE VISIT. ADDITIONAL INFORMATION FROM REPORTER INDICATED THE PATIENT'S TOPICAL STEROID DOSAGE WAS INCREASED AND THE REPORTED EVENT RESOLVED AFTER ONE WEEK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348985 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention