BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LADARVISION 4000

    MDR report key: 1082580 · Received July 25, 2008

    Report

    Report Number
    1061857-2008-00167
    Event Type
    Injury
    Date Received
    July 25, 2008
    Date of Event
    May 1, 2008
    Report Date
    June 27, 2008
    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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DETERMINATION OF ROOT CAUSE: ASSESSMENT: A SURGERY PERFORMANCE VERIFICATION WAS CONDUCTED ON THIS SYSTEM FROM EVENT DATE THROUGH THE FOLLOWING MONTH. THE ANALYSIS DETERMINED THAT THE LASER PERFORMANCE FACTORS ANALYZED WERE OPERATING WITHIN SPECIFICATION DURING THE TIME OF THIS PATIENT'S SURGERY. NON-PRODUCT FACTORS INCLUDING PT RESPONSE TO THE LASER ABLATION, PT HEALING CHARACTERISTICS AND PREOPERATIVE PT SELECTION COULD NOT BE REVIEWED AS THE SURGEON DECLINED TO PROVIDE ANY SPECIFIC PT INFO. HIS LAST STATEMENT REGARDING THE PATIENT'S VISION DOES NOT INDICATE BCVA OR UCVA AND THERE ARE NO PRE-OPERATIVE MEASUREMENTS FOR COMPARISON. 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 DECREASE IN BCVA. HOWEVER, THE NON-PRODUCT RELATED FACTORS MENTIONED ABOVE MAY HAVE BEEN CONTRIBUTOR.

    Description of Event or Problem · 1

    A SURGEON REPORTS ONE PT WITH DECREASED BCVA FOLLOWING LASIK SURGERY. FOLLOW-UP WITH THE SURGEON INDICATES THE PATIENT'S VISION HAS RETURNED TO 20/20, THE TOPOGRAPHIES LOOK WELL CENTERED, THE EPITHELIAL IRREGULARITIES HAVE CLEARED WITH THE USE OF DRY EYE MEDICATION AND PUNCTAL PLUGS. THE SURGEON ALSO STATED THE PT HAS NOT BEEN HARMED OR INJURED. THE SURGEON DID NOT PROVIDE ANY INFO REGARDING THIS PATIENT'S PRE-OP BCVA MEASUREMENT AND HAS DECLINED TO PROVIDE ANY OTHER INFO REGARDING THIS PT, AND REQUESTED WE NOT CONTACT HIM ANY FURTHER REGARDING THIS MATTER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other