BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 4100766 · Received September 12, 2014

    Report

    Report Number
    3003288808-2014-01384
    Event Type
    Injury
    Date Received
    September 12, 2014
    Date of Event
    August 14, 2014
    Report Date
    August 14, 2014
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WIL 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

    AN OPTOMETRIST REPORTED A PT WITH A SUSPECTED TRANSIENT LIGHT SENSITIVITY AT THREE MONTH LASIK POST-OPERATIVE VISIT. AT VISIT PATIENT COMPLAINED OF LIGHT SENSITIVITY FOR OVER A MONTH. ADDITIONAL INFO FROM REPORTER INDICATED THAT THE PT'S TOPICAL STEROID DOSAGE WAS INCREASED. ADDITIONAL INFO HAS BEEN REQUESTED. THIS REPORT IS FOR THE RIGHT EYE, AN ADDITIONAL REPORT WILL BE FILED FOR THE LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565162 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention INTRALASE