BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISX EXCIMER LASER

    MDR report key: 2409888 · Received January 5, 2012

    Report

    Report Number
    3006695864-2011-00150
    Event Type
    Injury
    Date Received
    January 5, 2012
    Date of Event
    November 30, 2011
    Report Date
    December 7, 2011
    Manufacturer
    AMO MANUFACTURING USA LLC
    Product Code
    LZS
    PMA / PMN Number
    K000327
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EPITHELIAL INGROWTH. NO CLINICAL SUPPORT OR SERVICE WAS REQUESTED. CUSTOMER REPORTING INCIDENT ONLY. ALL PERTINENT INFORMATION AVAILABLE TO AMO HAS BEEN SUBMITTED. SHOULD NEW INFORMATION THAT CHANGES THE FACTS AND/OR CONCLUSION OF THIS REPORT BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CLINIC REPORTED THAT A PATIENT, PREVIOUSLY TREATED FOR A LASER VISION ENHANCEMENT PROCEDURE 4 YEARS AGO, NOW PRESENTS WITH EPITHELIAL INGROWTH RIGHT EYE (OD). (B)(6) 2011, PATIENT PRESENTED FOR FOLLOW-UP AND AGAIN NOTED BLURRY VISION. THE DOCTOR LIFTED THE FLAP AND SCRAPED THE BED AND BACK OF FLAP. PTK (PHOTO REFRACTIVE KERATECTOMY) TREATMENT WAS DELIVERED TO THE BACK OF THE FLAP AND STROMAL BED. THIS IS A RECURRING EVENT FOR THIS PATIENT AND TWO SIMILAR EVENTS WERE REPORTED PREVIOUSLY: (B)(6) 2011 UNDER MW# 3006695864-2011-00109 AND (B)(6) 2011 UNDER MW# 3006695864-2011-00058.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISX EXCIMER LASER LZS AMO MANUFACTURING USA LLC STAR S4 IR

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention