BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 4122310 · Received September 18, 2014

    Report

    Report Number
    3003288808-2014-01437
    Event Type
    Injury
    Date Received
    September 18, 2014
    Date of Event
    August 18, 2014
    Report Date
    August 20, 2014
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    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

    AN OPTOMETRIST REPORTED THAT ONE YEAR FOLLOWING PHOTOREFRACTIVE KERATECTOMY (PRK), THE PATIENT PRESENTED WITH A CORNEAL ABRASION IN THE LEFT EYE. THE PATIENT REPORTED EXPERIENCING PAIN IN THE LEFT EYE. IN A FOLLOW UP, THE OPTOMETRIST REPORTED THAT THE ABRASION RESOLVED WITH THE TREATMENT AFTER TWO DAYS. THE TREATMENT CONSISTED OF A BANDAGE CONTACT LENS PLACED ON THE EYE, AS WELL AS ORAL MEDICATION. IN THE OPINION OF THE SURGEON, IT IS UNLIKELY THAT THE LASER CAUSED OR CONTRIBUTED TO THE EVENT. NO FURTHER INFORMATION IS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579133 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention RESTASIS EYE DROPS| ARTIFICIAL TEARS