BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 3834435 · Received May 6, 2014

    Report

    Report Number
    3003288808-2014-00774
    Event Type
    Injury
    Date Received
    May 6, 2014
    Date of Event
    April 12, 2014
    Report Date
    April 12, 2014
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS (DHR) FOR THE DEVICE WAS REVIEWED. THE ASSOCIATED DEVICE WAS RELEASED BASED ON COMPANY ACCEPTANCE CRITERIA. TECHNICAL SUPPORT PROVIDED AND ANALYZED THE SERVICE HISTORY WHICH INDICATES PROPER AND PERIODIC MAINTENANCE HAS BEEN COMPLETED. TECHNICAL ROOT CAUSE COULD NOT BE DETERMINED AS THE SYSTEM WAS PERFORMING WITHIN SPECIFICATION AND AS INTENDED. THE CONTRIBUTING FACTORS COULD BE STERILIZATION OF INSTRUMENTS, SURGICAL TECHNIQUES, PRE AND POST-OPERATIVE MEDICATIONS. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADD'L INFO, A COMPLETED QUESTIONNAIRE WAS NOT RECEIVED. (B)(4).

    Description of Event or Problem · 1

    AN OPTOMETRIST REPORTED THAT A PT EXPERIENCED STAGE 1 DIFFUSE LAMELLAR KERATITIS (DLK) IN THE RIGHT EYE, WITH PT COMMENT OF FOREIGN BODY SENSATION. ADD'L INFO WAS RECEIVED FROM A TECHNICIAN WHO REPORTED THE EVENT HAS RESOLVED. ADD'L INFO WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270144 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention INTRALASE