BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 4223656 · Received October 31, 2014

    Report

    Report Number
    3003288808-2014-01601
    Event Type
    Injury
    Date Received
    October 31, 2014
    Date of Event
    October 2, 2014
    Report Date
    October 3, 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. 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

    A CENTER DIRECTOR REPORTED THAT SEVEN MONTHS FOLLOWING PRIMARY, BILATERAL LASIK SURGERY, A PATIENT HAD A LASIK ENHANCEMENT IN THE LEFT EYE. THE CORNEAL FLAP WAS LIFTED AND RINSED DURING THE ENHANCEMENT, TEAR OF THE FLAP OCCURRED, AND THE PATIENT DEVELOPED STRIAE. THE PATIENT REPORTED FEELING DISCOMFORT IN THE LEFT EYE. IN A FOLLOW UP, THE CENTER DIRECTOR REPORTED THAT THE STRIAE HAD RESOLVED WITHIN THREE WEEKS, AND THE CORNEAL FLAP WAS HEALING NICELY. THE PATIENT WAS DOING WELL AT THE LAST POSTOPERATIVE VISIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698035 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention INTRALASE