BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX PLUS

    MDR report key: 1221255 · Received November 5, 2008

    Report

    Report Number
    1061857-2008-00186
    Event Type
    Injury
    Date Received
    November 5, 2008
    Date of Event
    January 1, 1995
    Report Date
    October 6, 2008
    Manufacturer
    ALCON - ORLANDO TECHNOLOGY CENTER
    Product Code
    LZS
    PMA / PMN Number
    P930034
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DETERMINATION OF ROOT CAUSE: ASSESSMENT: INVESTIGATION OF THE DEVICE COULD NOT BE PERFORMED BECAUSE NO PROD IDENTIFICATION INF WAS PROVIDED. NON-PROD FACTORS INCLUDING PT RESPONSE TO THE LASER ABLATION, PT HEALING CHARACTERISTICS AND PREOPERATIVE PT SELECTION COULD NOT BE REVIEWED BECAUSE NO PT SPECIFIC/CLINICAL RECORDS WERE PROVIDED FOR REVIEW. IN ADDITION, NO SPECIFIC INFO REGARDING THE TYPE OF 'CORNEAL PROBLEMS' WAS PROVIDED. CONCLUSION: BASED ON THE LIMITED INFO PROVIDED, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FOR THE REPORTED EVENT.

    Description of Event or Problem · 1

    A PT EXPERIENCED CORNEAL PROBLEMS FOLLOWING REFRACTIVE SURGERY. THE PT CONSIDERS THE CORNEAL PROBLEMS WERE DUE TO THE SURGERY. NO CONTACT INFO WAS PROVIDED FOR EITHER THE SURGEON OR THE PT, AND NO FURTHER INFO IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other