BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAR S4-IR-ETL EXCIMER LASER

    MDR report key: 2832270 · Received November 14, 2012

    Report

    Report Number
    3006695864-2012-00177
    Event Type
    Injury
    Date Received
    November 14, 2012
    Date of Event
    March 16, 2012
    Report Date
    October 18, 2012
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    LZS
    PMA / PMN Number
    P930016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CLINIC DID NOT REQUEST FIELD SERVICE ON THEIR SYSTEM HOWEVER THEY DID REQUEST CLINICAL SUPPORT. THE AMO CLINICAL DEVELOPMENT MANAGER PROVIDED CLINICAL SUPPORT TO THE SITE AND MADE RECOMMENDATIONS ON IMPROVING OUTCOMES WHICH INCLUDED IMPROVING WAVESCAN CAPTURES. THE STAFF WAS REMINDED ON THE DISCONTINUANCE OF CONTACT LENS PRIOR TO TREATMENTS AND THE IMPORTANCE OF MAINTAINING THE HUMIDITY AND TEMPERATURE OF THE SUITE. THE CLINICAL DEVELOPMENT MANAGER ALSO ADVISED THE CUSTOMER TO HAVE A PREVENTIVE MAINTENANCE (PM) PERFORMED ON THEIR WAVESCAN SINCE THIS HAD NOT BEEN PERFORMED WITHIN THE LAST THREE YEARS. A REVIEW OF FIELD SERVICE RECORDS REVEALED THAT AN AMO FIELD SERVICE ENGINEER SERVICED THE EXCIMER LASER PRIOR TO THE PATIENT'S TREATMENT AND THE SYSTEM WAS WITHIN SPECIFICATION AT THE COMPLETION OF THE SERVICE. THE EXCIMER LASER WAS ALSO SERVICED FOR A PREVENTIVE MAINTENANCE ABOUT FOUR MONTHS AFTER THE TREATMENT AND NO ISSUES WERE FOUND. ALL PERTINENT INFORMATION AVAILABLE TO AMO HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    THE DOCTOR REPORTED THAT A LASER VISION CORRECTION PATIENT PRESENTED WITH AN UNDERCORRECTION AND LOSS OF BEST CORRECTED VISUAL ACUITY (BCVA) AT A THREE MONTH POST OP EXAMINATION IN THE LEFT EYE. THE PATIENT WAS FURTHER DIAGNOSED WITH SUPERFICIAL PUNCTATE KERATITIS (SPK) IN THE LEFT EYE AND THIS WAS NOTED AS THE CAUSE OF THE LOSS OF BCVA. THE PATIENT'S BCVA AT THREE MONTHS WAS 20/25 IN THE RIGHT EYE AND 20/30 IN THE LEFT EYE. AT THE FIVE MONTH POST OP EXAM THE PATIENT'S UNCORRECTED VISUAL ACUITY WAS 20/25 IN THE RIGHT EYE AND 20/25 IN THE LEFT EYE. THE PATIENT WAS TREATED WITH TOPICAL LUBRICANTS AND PUNCTAL PLUGS. THE DOCTOR REQUESTED CLINICAL SUPPORT BE PERFORMED TO REVIEW STAFF PROCEDURES AND FOR OPTIMIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STAR S4-IR-ETL EXCIMER LASER EXCIMER LASER LZS ABBOTT MEDICAL OPTICS S4-IR-ETL

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention