BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 1202832 · Received October 17, 2008

    Report

    Report Number
    3003288808-2008-00017
    Event Type
    Injury
    Date Received
    October 17, 2008
    Date of Event
    June 2, 2006
    Report Date
    July 10, 2008
    Manufacturer
    WAVELIGHT AG (PRESSATH)
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DETERMINATION OF ROOT CAUSE: ASSESSMENT: THE DATABASE LOGFILE FOR THIS SYSTEM WAS REVIEWED AND THE ANALYSIS DETERMINED THE DEVICE WAS OPERATING WITHIN SPECIFICATION DURING THE TIME OF THIS PT'S SURGERY. NON-PRODUCT FACTORS INCLUDING PT RESPONSE TO THE LASER ABLATION, PT HEALING CHARACTERISTICS AND PREOPERATIVE PT SELECTION WERE REVIEWED. THE PT PRESENTED WITH A NON-CONTRIBUTORY MEDICAL HISTORY AND ON OCULAR HISTORY POSITIVE FOR DRY EYE AND UNDERWENT CONVENTIONAL SPHERICAL HYPEROPIA LASIK. THE PT WAS NOTED FOR "LOOSE EPITHELIUM REPOSITIONED-8.4 SCL (SOFT CONTACT LENS) PLACED" IMMEDIATELY AFTER THE PROCEDURE. THE PT DEMONSTRATED A TEMP 2-LINE LOSS OF BCVA AT THE ONE MONTH POSTOPERATIVE VISIT THAT IMPROVED TO A ONE LINE LOSS BY THE 11 MONTH VISIT. THIS MAY HAVE BEEN ASSOCIATED TO THE INITIAL POSTOPERATIVE COMPLICATION OF LOOSE EPITHELIUM AND THE PRE EXISTING CONDITION OF DRY EYE. (BILATERAL EPITHELIAL DEFECTS AFTER LASER IN SITU KERATOM ILEUSES. CLINICAL FEATURES, MGMT AND OUTCOME, SRINIVAS RAO ET AL, FOREIGN JOURNAL OF OPHTHALMOLOGY VOL 53:1 P 37-42, 2005). THESE COMPLICATIONS MAY HAVE CAUSED TEMPORARY AND UNPREDICTABLE CHANGES IN THE CORNEA THAT MAY INTERFERE WITH THE ABILITY TO PROPERLY MEASURE THE REFRACTIVE ERROR AND VISUAL ACUITY THEREBY CONTRIBUTING TO A POTENTIAL LOSS OF BCVA. (REFRACTIVE SURGERY NIGHTMARES, FAHMY, HARDTEN, CHAPTER 35) DRY EYE IS THE MOST FREQUENT COMPLICATION AFTER REFRACTIVE SURGERY, PARTICULARLY IN LASIK SURGERY, AND STUDIES INDICATE THAT DRY-EYE SYMPTOMS BEFORE SURGERY ARE A STRONG PREDICTOR OF CHRONIC DRY EYE AFTER SURGERY. THEREFORE, LASIK SHOULD BE APPROACHED CAUTIOUSLY IN PTS WITH PREEXISTING DRY EYE. (CHRONIC DRY EYE AND REGRESSION AFTER LASER IN SITU KERATOMILEUSIS FOR MYOPIA, JULIE M. ALBIETZ PHD ET AL, JOUR OF CAT AND REF SURG, VOL 30:3, MARCH 2003). IN THIS CASE NO PREOPERATIVE TEAR ASSESSMENT WAS DOCUMENTED ALTHOUGH THE PRE PROCEDURE EVALUATION FORM INDICATED A PRE EXISTING CONDITION OF DRY EYE. IN ADDITION, A ONE LINE LOSS OF BCVA MAY NOT REPRESENT A TRUE LOSS AS IT MAY BE ASSOCIATED TO VARIATIONS IN TESTING TECHNIQUES. CONCLUSION: BASED ON THE RESULTS OF THE INVESTIGATION OF PRODUCT AND NON-PRODUCT FACTORS, THE DEVICE WAS NOT FOUND TO BE A CONTRIBUTOR TO THE DECREASE IN BCVA. HOWEVER, THE NON-PRODUCT RELATED FACTORS MENTIONED ABOVE MAY HAVE BEEN CONTRIBUTORS.

    Description of Event or Problem · 1

    AN OPTOMETRIST REPORTS A HYPEROPIC PT WITH A POOR CLINICAL OUTCOME, FOLLOWING BILATERAL LASIK SURGERY. THIS REPORT IS FOR THE RIGHT EYE, THE LEFT EYE WAS REPORTED UNDER MFR NUMBER 3003288808-2008-00006. AT ONE YEAR POST-OP, THIS PT EXHIBITED A 1 LINE DECREASE IN BCVA. THE PT ALSO REPORTED DRY EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT AG (PRESSATH) 8065990600 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other RESTASIS| VICODIN