BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 4083448 · Received August 19, 2014

    Report

    Report Number
    3003288808-2014-01291
    Event Type
    Injury
    Date Received
    August 19, 2014
    Date of Event
    February 28, 2014
    Report Date
    July 22, 2014
    Manufacturer
    WAVELIGHT GMVH
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE DEVICE HISTORY RECORDS (DHR) FOR THE DEVICE WAS REVIEWED. NO ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THIS EVENT WERE FOUND. THE ASSOCIATED DEVICE WAS RELEASED BASED ON COMPANY ACCEPTANCE CRITERIA. 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 FIVE MONTHS FOLLOWING BILATERAL LASIK SURGERY, THE PATIENT REPORTED BEING UNHAPPY WITH HIS NIGHT VISION. THE PATIENT REPORTED HIS VISION WAS 'STARRY' AT NIGHT. IN A FOLLOW UP, THE OPTOMETRIST REPORTED THAT THE PATIENT HAD RESIDUAL ASTIGMATISM, WITH GOOD VISUAL ACUITY. THE PATIENT REPORTED THAT THE 'STARRY VISION' WAS PRESENT AT DAYTIME, BUT WAS WORSE AT NIGHT, AS IT MADE LIGHTS LOOK FUZZY. PER THE OPTOMETRIST,THE PATIENT WAS INFORMED THAT IN SPITE OF THE RESIDUAL ASTIGMATISM, AN ENHANCEMENT WAS NOT INDICATED, AS HIS VISION WAS GOOD. THE PATIENT WAS NOT SATISFIED AND SAID HE WOULD SEEK A SECOND OPINION, FROM A DIFFERENT SURGEON, REGARDING A POSSIBLE ENHANCEMENT. NO FURTHER INFORMATION IS EXPECTED. THERE ARE TOW MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497064 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMVH 8065990601 N

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Other INTRALASE