BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 4081135 · Received September 5, 2014

    Report

    Report Number
    3003288808-2014-01351
    Event Type
    Injury
    Date Received
    September 5, 2014
    Date of Event
    August 9, 2014
    Report Date
    August 9, 2014
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, 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. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFO. A COMPLETED QUESTIONNAIRE WAS NOT RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A TECHNICIAN REPORTED THAT A PT, PRESENTED WITH DIFFUSE CORNEA STIPPLING, APPROXIMATELY 1 MONTH FOLLOWING BILATERAL LASIK SURGERY. THE PT REPORTED HIS "VISION IS GETTING BETTER, HAVE DAYS OF SENSITIVITY AND DRYNESS". THE EVENT WAS TREATED WITH SODIUM CHLORIDE HYPERTONICITY OPHTHALMIC DROPS. ADDITIONAL INFO HAS BEEN REQUESTED. 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
    543259 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention INTRALASE