BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LADARVISION 4000

    MDR report key: 824050 · Received February 28, 2007

    Report

    Report Number
    1061857-2007-00022
    Event Type
    Injury
    Date Received
    February 28, 2007
    Date of Event
    October 6, 2006
    Report Date
    November 29, 2006
    Manufacturer
    ALCON - ORLANDO TECHNOLOGY CENTER
    Product Code
    DZS
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SYSTEM PERFORMANCE VERIFICATION WAS PERFORMED ON THIS SYSTEM. ANALYSIS INDICATES THE SYSTEM WAS OPERATING WITHIN SPECIFICATIONS FOR THE RECORDED PARAMETERS DURING THE TIME OF THIS PATIENT'S SURGERY. DETERMINATION OF ROOT CAUSE: 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 WERE REVIEWED. IN THIS CASE, SPECIFIC NON-PRODUCT FACTORS THAT COULD HAVE CONTRIBUTED TO THE LOSS OF BCVA FOR THE OS COULD NOT BE DETERMINED. NO COMMENTS OR EXPLANATIONS WERE DOCUMENTED BY THE SITE NOR WERE ADDITIONAL TESTS (SUCH AS PIN-HOLE ACUITY) WERE PERFORMED TO CONFIRM OR DENY THE LOSS OF BCVA. IN REGARDS TO THE INDUCED ASTIGMATISM FOR BOTH EYES, POSTOPERATIVE TOPOGRAPHIES WERE NOT PROVIDED TO DETERMINE THE CAUSE OF THE INDUCED ASTIGMATISM, THEREFORE SPECIFIC NON-PRODUCT FACTORS COULD NOT BE DETERMINED. FOR THE .75D OVERCORRECTION NOTED FOR THE OS, NO SPECIFIC NON-PRODUCT FACTORS COULD BE DETERMINED. CONCLUSION: BASED ON THE INFORMATION PROVIDED, AN INDIVIDUAL PATIENT RESPONSE AND HEALING CHARACTERISTICS MAY HAVE CONTRIBUTED TO THE OUTCOMES.

    Description of Event or Problem · 1

    A SYSTEM OPERATOR REPORTS ONE CUSTOM PATIENT WITH AN OVERCORRECTION POST-OP. PATIENT RECORDS PROVIDED INDICATE AT APPROXIMATELY 3.5 MONTHS POST-OP, THIS PATIENT WAS OVERCORRECTED BY .75 DIOPTERS IN THE LEFT EYE. DURING THE INVESTIGATION, IT WAS FOUND THAT THIS PATIENT ALSO EXHIBITED A 2-LINE DECREASE IN BCVA IN THE LEFT EYE AND BOTH EYES EXHIBITED A SLIGHT INCREASE IN ASTIGMATISM; -1 DIOPTER IN THE RIGHT EYE AND -.75 DIOPTERS IN THE LEFT EYE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other