BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISX EXCIMER LASER

    MDR report key: 2436884 · Received January 30, 2012

    Report

    Report Number
    3006695864-2012-00007
    Event Type
    Injury
    Date Received
    January 30, 2012
    Date of Event
    January 1, 2007
    Report Date
    January 16, 2012
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    LZS
    PMA / PMN Number
    P930016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF OUR CUSTOMER RECORDS REVEALS THAT THE TREATING FACILITY DID NOT REPORT THIS INCIDENT INTO AMO. 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

    A PT REPORTED SHE HAD LASER VISION CORRECTION IN BOTH EYES 4 YEARS AGO AND HAS EXPERIENCED DIFFICULTY WITH HER VISION IN HER RIGHT EYE. IN ADDITION THE PT REPORTED SHE IS ALSO EXPERIENCING SEVERE DRY EYE. THE PT'S INITIAL TREATMENT WAS FOR MONOVISION AND SHE WAS TREATED FOR NEAR VISION IN HER RIGHT EYE AND FAR VISION IN HER LEFT EYE. SHE INDICATED THAT SHE HAS HAD ONE ENHANCEMENT TREATMENT ON HER RIGHT EYE SINCE THE INITIAL TREATMENT. DURING FOLLOW-UP VISITS WITH HER DOCTOR SHE INDICATED THAT SHE WAS DIAGNOSED WITH MAP DOT DYSTROPHY AND A SCAR IN HER RIGHT EYE. CURRENTLY HER RIGHT EYE IS CORRECTABLE TO 20/50. THE PT HAS BEEN TOLD BY A DIFFERENT EYE CARE PRACTITIONER THAT HER ONLY TREATMENT OPTIONS ARE FOR A CORNEAL TRANSPLANT IN HER RIGHT EYE.

    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