BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 4151976 · Received October 6, 2014

    Report

    Report Number
    3003288808-2014-01485
    Event Type
    Injury
    Date Received
    October 6, 2014
    Date of Event
    September 11, 2014
    Report Date
    September 11, 2014
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE DEVICE HISTORY RECORDS (DHR) FOR THE DEVICE WERE REVIEWED. THE ASSOCIATED DEVICE WAS RELEASED BASED ON 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

    A TECHNICIAN REPORTED THAT A PATIENT PRESENTED WITH MILD CORNEAL EDEMA AND CORNEAL ABRASIONS, ONE DAY FOLLOWING LASIK SURGERY. THE PATIENT REPORTED THAT THE LEFT EYE WAS VERY SORE. IN A FOLLOW UP, THE TECHNICIAN REPORTED THAT THE PATIENT WAS TREATED WITH A BANDAGE CONTACT LENS FOR ONE DAY. HE RETURNED ONE DAY LATER FOR FOLLOW UP, THE EVENT HAD RESOLVED, AND THE BANDAGE CONTACT LENS WAS REMOVED. NO FURTHER INFORMATION IS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623868 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention