BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 2982465 · Received February 26, 2013

    Report

    Report Number
    3003288808-2013-00074
    Event Type
    Injury
    Date Received
    February 26, 2013
    Date of Event
    January 26, 2013
    Report Date
    January 31, 2013
    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 INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A TECH REPORTED THAT A PT WAS DIAGNOSED WITH A MILD INFECTION IN THE RIGHT EYE, THREE MONTHS AFTER HAVING LASIK SURGERY. THE LASIK SURGERY INS NOT BELIEVED TO HAVE CAUSED THE INFECTION, HOWEVER NO OTHER SUSPECTED CAUSE HAS BEEN REPORTED. THE PT REPORTED THAT THE VISION WAS GOOD IN BOTH EYES FOR DISTANCE AND NEAR. TOPICAL ANTIBIOTIC DROPS WERE PRESCRIBED. THE PT ELECTED TO CANCEL THE FOLLOW-UP APPOINTMENT, CITING THAT THE INFECTION HAD IMPROVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81336 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Required Intervention