BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 2881567 · Received December 17, 2012

    Report

    Report Number
    3003288808-2012-00521
    Event Type
    Injury
    Date Received
    December 17, 2012
    Date of Event
    November 29, 2012
    Report Date
    November 30, 2012
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    =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

    A TECHNICIAN REPORTED THAT A PT WHO HAD UNDERGONE LASIK, CAME IN TO THE CLINIC 17 MONTHS POST LASIK, AND REPORTED BLURRY VISION. THE PT WAS DIAGNOSED WITH SUSPICIOUS STEEPENING OF BOTH CORNEAS, MORE SO IN THE LEFT. THIS REPORT CONCERNS THE RIGHT EYE. THE EXAMINATION FINDINGS WERE EXPLANTED TO THE PT, AND THE PT WILL RETURN TO THE CLINIC IN THREE TO SIX MONTHS TO BE OBSERVED FOR PROGRESSION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other