BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LADARVISION 4000 LASER

    MDR report key: 1430478 · Received August 5, 2009

    Report

    Report Number
    1061857-2009-00077
    Event Type
    Injury
    Date Received
    August 5, 2009
    Date of Event
    March 1, 2004
    Report Date
    July 6, 2009
    Manufacturer
    ALCON - ORLANDO TECHNOLOGY CENTER
    Product Code
    LZS
    PMA / PMN Number
    P970043
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DETERMINATION OF ROOT CAUSE: ASSESSMENT: A SURGERY DATABASE PERFORMANCE VERIFICATION WAS PERFORMED ON THIS LASER SYSTEM. THE ANALYSIS DETERMINED THE LASER PERFORMANCE FACTORS ANALYZED WERE OPERATING WITHIN SPECIFICATION DURING THE TIME OF THIS PATIENT'S SURGERY. DURING THE ON-SITE INVESTIGATION, THE ENGINEER WAS UNABLE TO FIND ANY ISSUES WITH THE LASER AND COMPLETED A SUCCESSFUL SYSTEM VERIFICATION TO SPECIFICATIONS. NON-PRODUCT FACTORS INCLUDING PATIENT RESPONSE TO THE LASER ABLATION, PATIENT HEALING CHARACTERISTICS AND PREOPERATIVE PATIENT SELECTION COULD NOT BE REVIEWED BECAUSE THE SURGEON DECLINED TO PROVIDE CLINICAL RECORDS OR ANY OTHER PATIENT SPECIFIC INFORMATION. THE SURGEON ONLY PROVIDED LIMITED PRE AND POST-OP MANIFEST RETRACTIONS AND BCVA IN A SPREADSHEET FORMAT. AT 3 MONTHS POST-OP, THIS PATIENT EXHIBITED INDUCED ASTIGMATISM. POSSIBLE CAUSES OF INDUCED ASTIGMATISM INCLUDE, BUT ARE NOT LIMITED TO, INACCURATE ORIENTATION OF THE ABLATION PROFILE BECAUSE OF INADEQUATE PREOPERATIVE EVALUATION OR FEEDING INCORRECT DATA INTO THE LASER, FLAP RETRACTION TOWARDS THE HINGE, POOR PATIENT ALIGNMENT, FLAP WOUND HEALING, AND OTHER SURGICAL TECHNIQUES INCLUDING ATTENTION TO DETAIL IN INSTRUMENTATION AND POSTOPERATIVE CARE. REFERENCES: INDUCED ASTIGMATISM AFTER LASIK, RODRIGUEZ-PRATS ET AL, J OF CAT AND REF SURG, VOL 29:2, FEB 2003. SURGICALLY INDUCED ASTIGMATISM AFTER LASIK FOR SPHERICAL MYOPIA, HERSH, J OF REFRACTIVE SURGERY, VOL 17:2, MARCH/APRIL 2001. THE CORNEA: SCIENTIFIC FOUNDATIONS AND CLINICAL PRACTICE, SMOLIN ET AL, LIPPINCOT, 2004. MANAGEMENT OF IRREGULAR ASTIGMATISM INDUCED BY LASER IN SITU KERATOMILEUSIS, POLACK ET AL, INTERNATIONAL OPHTHALMOLOGY CLINICS, VOL 43:3, SUMMER 2003. LASIK: FUNDAMENTALS, SURGICAL TECHNIQUES AND COMPLICATIONS, AKERS ET AL, INFORMA HEALTH CARE, 2003. 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 INDUCED ASTIGMATISM. HOWEVER, THE NON-PRODUCT RELATED FACTORS MENTIONED ABOVE MAY HAVE BEEN CONTRIBUTORS.

    Description of Event or Problem · 1

    A SURGEON REPORTS DISSATISFACTION WITH PATIENT OUTCOMES. INFORMATION PROVIDED BY THE SURGEON INDICATES THIS PATIENT RECEIVED A BILATERAL LASIK TREATMENT. AT 3 MONTHS POST-OP, THIS PATIENT EXHIBITED INDUCED ASTIGMATISM. IT IS UNCLEAR IF THE SURGEON FEELS THIS PATIENT IS HARMED/INJURED, HOWEVER, THE SURGEON HAS DECLINED TO PROVIDE ANY ADDITIONAL INFORMATION. THIS REPORT IS FOR THE LEFT EYE, THE RIGHT EYE IS BEING REPORTED UNDER MANUFACTURER REPORT # 1061857-2009-00076.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LADARVISION 4000 LASER EXCIMER LASER SYSTEM LZS ALCON - ORLANDO TECHNOLOGY CENTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Other