BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LADARVISION 4000

    MDR report key: 798721 · Received December 22, 2006

    Report

    Report Number
    1061857-2006-00227
    Event Type
    Injury
    Date Received
    December 22, 2006
    Date of Event
    November 27, 2006
    Report Date
    November 27, 2006
    Manufacturer
    ALCON LABORATORIES IRELAND LTD, ALCON ORLANDO TECH CTR
    Product Code
    LZS
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SURGERY DATABASE PERFORMANCE VERIFICATION WAS CONDUCTED ON THIS SYSTEM AND DETERMINED THE LASER PERFORMANCE FACTORS ANALYZED WERE OPERATING WITHIN SPECIFICATION. ASSESSMENT: THE CONCLUSION OF THE DEVICE INVESTIGATION INDICATES THE SYSTEM PERFORMED WITHIN SPECIFICATIONS DURING THIS PATIENT'S SURGERY. NON-PRODUCT FACTORS INCLUDING PATIENT RESPONSE TO THE LASER ABLATION, PATIENT HEALING CHARACTERISTICS AND PREOPERATIVE PATIENT SELECTION COULD NOT BE REVIEWED AS THE SURGEON DECLINED TO PROVIDE ANY PATIENT INFORMATION. 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 REPORTED OVERCORRECTION. HOWEVER, THE NON-PRODUCT RELATED FACTORS MENTIONED ABOVE COULD NOT BE RULED OUT AND MAY HAVE BEEN CONTRIBUTORS.

    Description of Event or Problem · 1

    A SYSTEMS OPERATOR REPORTS 5 PATIENTS WITH OVERCORRECTIONS FOLLOWING LASIK SURGERY. THE SURGEON DECLINED TO PROVIDE ANY PATIENT INFORMATION, SO THE AMOUNT OF THE OVERCORRECTIONS IS NOT KNOWN. THIS PATIENT IS BEING REPORTED UNDER MANUFACTURER'S REPORT #1061857-2006-00227. THE OTHER 4 PATIENTS ARE BEING REPORTED UNDER MANUFACTURER'S REPORT#: 1061857-2006-00228, 1061857-2006-00229, 1061857-2006-00230, 1061857-2006-00231.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LADARVISION 4000 OPHTHALMIC EXCIMER LASER SYSTEM LZS ALCON LABORATORIES IRELAND LTD, ALCON ORLANDO TECH CTR NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other