BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 3950618 · Received July 11, 2014

    Report

    Report Number
    3003288808-2014-01107
    Event Type
    Injury
    Date Received
    July 11, 2014
    Date of Event
    November 14, 2013
    Report Date
    June 12, 2014
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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).

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS MAILED TO FDA ON: 08/22/2014. (B)(4).

    Description of Event or Problem · 1

    A DOCTOR REPORTED THAT ONE MONTH FOLLOWING LASIK SURGERY, THE PATIENT WAS DIAGNOSED WITH EPITHELIAL INGROWTHS IN THE LEFT EYE. THE FLAP WAS LIFTED, AND DEBRIDEMENT AND RINSE WERE PERFORMED TO TREAT THE EVENT. THE PATIENT WAS ASYMPTOMATIC, AND VISUAL ACUITY WAS NOT AFFECTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    IN A FOLLOW UP, THE SURGEON REPORTED THAT THE EVENT RESOLVED WITH THE TREATMENT, TWO WEEKS LATER. IN THE OPINION OF THE SURGEON, THE DEVICE DID NOT CAUSE OR CONTRIBUTED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406837 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Required Intervention