BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 2880981 · Received December 14, 2012

    Report

    Report Number
    3003288808-2012-00504
    Event Type
    Injury
    Date Received
    December 14, 2012
    Date of Event
    November 6, 2012
    Report Date
    November 14, 2012
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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 PATIENT WHO HAD UNDERGONE BILATERAL LASIK WAS EXPERIENCING DRYNESS IN BOTH EYES AND BLURRY VISION IN BOTH EYES. THIS REPORT WILL ADDRESS THE PATIENT'S RIGHT EYE. THE PATIENT WAS LAST SEEN AT A RELATED CORPORATE CLINIC ON (B)(6) 2012. THE PATIENT REPORTED THAT HE WAS NOT CONFIDENT THE VISION WAS CLEARING UP IN THE RIGHT EYE. THE REPORTER DECLINED TO PROVIDE ANY ADDITIONAL DETAILS.

    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 56 YR Other INTRALASE