BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 3950924 · Received July 14, 2014

    Report

    Report Number
    3003288808-2014-01100
    Event Type
    Injury
    Date Received
    July 14, 2014
    Date of Event
    June 16, 2014
    Report Date
    June 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
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: 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 EXPERIENCED A GRITTY AND SORE FEELING IN HER EYE AS A RESULT OF DECREASED TEAR PRODUCTION CAUSING DRY EYES, 4 DAYS FOLLOWING BILATERAL LASIK SURGERY. IN A FOLLOW UP, THE TECHNICIAN REPORTED THAT THE PATIENT WAS TREATED WITH MEDICATIONS AND THE EVENT IS IMPROVING. THE PATIENT WILL RETURN FOR FOLLOW UP CARE IN A MONTH. NO FURTHER INFORMATION IS EXPECTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410157 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention INTRALASE (2014)