BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LADARVISION

    MDR report key: 844007 · Received April 25, 2007

    Report

    Report Number
    1061857-2007-00173
    Event Type
    Injury
    Date Received
    April 25, 2007
    Date of Event
    February 23, 2006
    Report Date
    December 6, 2006
    Manufacturer
    ALCON - ORLANDO TECHNOLOGY CENTER
    Product Code
    DZS
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DETERMINATION OF ROOT CAUSE: ASSESSMENT: A SURGERY DATABASE PERFORMANCE VERIFICATION WAS CONDUCTED ON THIS SYSTEM. THE ANALYSIS INDICATED THE LASER PERFORMANCE FACTORS ANALYZED WERE OPERATING WITHIN SPECIFICATION DURING THIS PATIENT'S SURGERIES. PATIENT RECORDS WERE REVIEWED FOR NON-PRODUCT FACTORS INCLUDING PATIENT RESPONSE TO THE LATER ABLATION, PATIENT HEALING CHARACTERISTICS AND PREOPERATIVE PATIENT SELECTION. NO SPECIFIC NON-PRODUCT FACTORS COULD BE IDENTIFIED OR THE INITIAL OVERCORRECTION NOTED. FOLLOWING THE ENHANCEMENT, THE RECORDS INDICATE POSTOPERATIVE COMPLICATIONS FOR THE LEFT EYE INDICATING A FLAP LIFT-REFLOAT AND REFRACTIVE INSTABILITY. THE RECORDS DO NOT INDICATE ANY POTENTIAL CONTRIBUTING FACTORS FOR THE DECREASED BCVA IN THE LEFT EYE; HOWEVER, PRE-ENHANCEMENT MEASUREMENTS AS WELL AS THE POST-ENHANCEMENT TOPOGRAPHIES SUGGEST A THIN CORNEA FOR THE LEFT EYE. IT IS NOT UNCOMMON FOR THE CORNEA TO DEMONSTRATE A HYPEROPIC-ASTIGMATIC REFRACTIVE ERROR SECONDARY TO CORNEAL THINNING. 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

    A SURGEON REPORTS A PATIENT THAT IS OVERCORRECTED FOLLOWING REFRACTIVE SURGERY. PATIENT RECORDS WERE PROVIDED AND INDICATE AT 6 MONTHS POST-OP, THIS PATIENT EXHIBITED A 1D OVERCORRECTION IN THE LEFT EYE AND BCVA IN THE LEFT EYE DECREASED FROM 20/20 PRE-OP TO 20/25. AN ENHANCEMENT WAS PERFORMED 8 MONTHS FOLLOWING THE INITIAL PROCEDURE. AT APPROXIMATELY 6 WEEKS POST-ENHANCEMENT, THE OVERCORRECTION HAD RESOLVED; HOWEVER, BCVA WAS NOW 20/40. UCVA IMPROVED FROM 20/CF PRE-OP TO 20/50-2 AT 6-WEEKS POST-ENHANCEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other