BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISX EXCIMER LASER

    MDR report key: 2484126 · Received March 8, 2012

    Report

    Report Number
    3006695864-2012-00038
    Event Type
    Injury
    Date Received
    March 8, 2012
    Date of Event
    July 1, 2010
    Report Date
    May 7, 2012
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    LZS
    PMA / PMN Number
    K000327
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN AMO FIELD SERVICE ENGINEER EXAMINED THE LASER AT THE CUSTOMER'S LOCATION AND NO ISSUES WERE FOUND THAT WERE RELATED TO THE REPORTED EVENT. ALL PERTINENT INFORMATION AVAILABLE TO AMO HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS ORIGINALLY REPORTED AS HAVING AN OVERCORRECTION; HOWEVER, THE CLINIC CORRECTED THEIR INITIAL ASSESSMENT INDICATING THE PATIENT WAS NOT OVERCORRECTED. THE PATIENT'S VISUAL ACUITIES STABILIZED WITHIN THE NORMAL POST OP PERIOD AND SHE REQUIRED NO FURTHER TREATMENT. THE PATIENT WAS 20/20 UNCORRECTED IN EACH EYE. (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. SHOULD NEW INFORMATION BE RECEIVED THAT CHANGES THE FACTS AND/OR CONCLUSION OF THIS REPORT, ANOTHER SUPPLEMENTAL REPORT WILL BE SUBMITTED. PLACEHOLDER.

    Description of Event or Problem · 1

    THE CLINIC REPORTED THAT THE DOCTOR HAD A PHOTOREFRACTIVE KERATECTOMY (PRK) OVERCORRECTION ON (B)(6) 2010. THE EXACT EVENT DATE WAS NOT PROVIDED.

    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 Other