BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 4100752 · Received September 12, 2014

    Report

    Report Number
    3003288808-2014-01390
    Event Type
    Injury
    Date Received
    September 12, 2014
    Date of Event
    August 16, 2014
    Report Date
    August 16, 2014
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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. 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 INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A TECHNICIAN REPORTED A PT WHO FELT THAT ENHANCEMENT FAILED AT ONE DAY LASIK ENHANCEMENT POST-OPERATIVE VISIT. AT VISIT PT COMPLAINED OF BLURRY VISION AND INDICATED "SHE IS NOT SEEING BETTER AND THAT SHE HAS WASTED HER MONEY, SHE STILL NEEDS GLASSES AND ASKED FOR ANOTHER SURGEON WHO IS AVAILABLE". ADDITIONAL INFO FROM REPORTER INDICATED THE PT HAS NOT BEEN SEEN BUT IS SCHEDULED FOR ANOTHER POST-OPERATIVE VISIT. THIS REPORT IS FOR THE RIGHT EYE, AND ADDITIONAL REPORT WILL BE FILED FOR THE LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565118 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention INTRALASE