BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 3221794 · Received July 9, 2013

    Report

    Report Number
    3003288808-2013-00404
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    June 10, 2013
    Report Date
    June 11, 2013
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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).

    Description of Event or Problem · 1

    AN OPTOMETRIST REPORTED A CASE OF SIGNIFICANT INFLAMMATION AND CORNEAL INFECTION, POST-OPERATIVELY AFTER BILATERAL PRK (PHOTOREFRACTIVE KERATECTOMY) SURGERY. THIS WAS NOTED ON THE FIVE DAY POST-OPERATIVE VISIT. REPORTER ALSO INFORMED THAT THE PT HAD NOT BEEN USING ANTIBIOTIC DROPS, BUT WAS USING THE NON-STEROIDAL ANTI-INFLAMMATORY DROPS, TEARS, AND OCCASIONALLY THE 'PINK CAP' DROP. PT COMMENTED BEING CONFUSED ABOUT WHAT DROPS HE SHOULD'VE BEEN TAKING AND COMPLAINED OF HALOS, GLARE, AND SHADOWS. UPON FOLLOW UP, REPORTER INFORMED THAT THE PT'S VISUAL ACUITY WAS STILL FLUCTUATING, AS A RESULT OF RESOLVING INFLAMMATION. REPORTER ALSO INDICATED THAT THE PT DEVELOPED A CORNEAL ULCER WHICH IS CURRENTLY RESOLVING, AND ALSO DISPLAYED SOME CORNEAL THINNING. PT WAS INSTRUCTED TO TAKE STEROID DROPS SIX TIMES PER DAY, UNTIL THE TWO WEEK POST-OPERATIVE VISIT. PT WAS ALSO REFERRED TO A CORNEA SPECIALIST. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THIS REPORT REFERENCES THE PT'S LEFT EYE. AN ADDITIONAL REPORT WILL BE FILED FOR THE RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313771 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention