BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 2932216 · Received January 25, 2013

    Report

    Report Number
    3003288808-2013-00020
    Event Type
    Injury
    Date Received
    January 25, 2013
    Date of Event
    November 28, 2012
    Report Date
    December 27, 2012
    Manufacturer
    WAVELIGHT AG
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS (DHR) FOR THE DEVICE WERE REVIEWED. THE ASSOCIATED DEVICE WAS RELEASED BASED ON COMPANY ACCEPTANCE CRITERIA. LOGFILE REVIEW FOR THE DATE OF EVENT SHOWS NO ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO REPORTED EVENT. THE TREATMENTS WERE COMPLETED TO 100%, WITHOUT ERROR MESSAGES. ALL LASER SYSTEM FUNCTIONS WERE WITHIN SPECIFICATIONS AT THIS DAY. A REVIEW OF THE TECHNICAL SERVICE ON-SITE SHOWED NO ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THIS EVENT. LASER WAS SUCCESSFULLY VERIFIED PRIOR TO, AND AFTER THE DAY OF THE EVENT. ANALYSIS OF THE SCANNER-TARGETS WITH THE SCANNER-TARGET MASK AND INSPECTION OF THE EYE TRACKER TARGETS WERE CONDUCTED. THE PMMA (POLYMETHYL METHACRYLATE) ABLATION TARGETS WERE SURVEYED WITH THE ABLATION DEPTH MEASURING PROBEIN THE X,Y, AND DIAGONAL DIRECTIONS. THE SCANNER TARGET AND THE EYE TRACKER TARGET SHOW NO DEVIATION. NO SIGNIFICANT DEVIATION BETWEEN TEST PMMA AND REFERENCE PMMA FOR THE ABLATION CHECK AND THE TREATMENT COULD BE MEASURED. NO TECHNICAL ROOT CAUSE COULD BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED OVERCORRECTION AND INDUCED ASTIGMATISM IN BOTH EYES FOLLOWING PRK (PHOTOREFRACTIVE KERATECTOMY). THIS REPORT CONCERNS THE PT¿S RIGHT EYE. THE SURGEON PERFORMED A TRANSEPITHELIAL ABLATION OF 50 MICRONS. NO FLUIDS WERE APPLIED BETWEEN THE ABLATION OF THE EPITHELIUM AND THE REFRACTIVE TREATMENT. THERE WAS APPROX 35 SECONDS BETWEEN THE EPITHELIUM AND THE REFRACTIVE TREATMENT. ADD¿L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35888 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT AG 8065990631 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other