BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAR S4-IR-ETL EXCIMER LASER

    MDR report key: 2950680 · Received February 8, 2013

    Report

    Report Number
    3006695864-2013-00032
    Event Type
    Injury
    Date Received
    February 8, 2013
    Date of Event
    November 30, 2012
    Report Date
    January 29, 2013
    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

    (B)(4): THE AMO CLINICAL DEVELOPMENT MANAGER WENT ON SITE AND PROVIDED SURGICAL SUPPORT TO THE CLINIC AND TREATING DOCTORS. THE CALIBRATION PLASTICS FOR TREATING DAYS WERE REVIEWED AND ALL WERE FOUND TO BE WITHIN SPECIFICATION. SURGICAL PROCEDURES AND CLEANING PROTOCOLS WERE REVIEWED. THE CLINICAL DEVELOPMENT MANAGER WAS NOT ABLE TO PINPOINT A SPECIFIC CAUSE FOR THE UNDERCORRECTIONS. THE AMO FIELD SERVICE ENGINEER CONDUCTED A THOROUGH INSPECTION OF THE EQUIPMENT AND FOUND THE LEFT OCULAR OF THE MICROSCOPE WAS OFF BY PLUS 1.5 DIOPTER AND CALIBRATION CUTS AND THE BEAM PROFILE WERE NOT ADJUSTING. THE FIELD SERVICE ENGINEER REPLACED COMPONENTS TO IMPROVE PERFORMANCE AND CORRECT THE ISSUES FOUND AND PERFORMED SYSTEM ALIGNMENTS AND CALIBRATIONS. ALL PERTINENT INFORMATION AVAILABLE TO AMO HAS BEEN SUBMITTED.  (B)(4): PLACEHOLDER.

    Description of Event or Problem · 1

    THE DOCTOR REPORTED THAT A LASER VISION CORRECTION PATIENT PRESENTED AT THE ONE MONTH POST OP EXAMINATION WITH AN UNDERCORRECTION IN BOTH EYES FOLLOWING A LASIK TREATMENT. THE PATIENT''S POST OP BCVA IS 20/25 IN THE RIGHT EYE AND 20/30 IN THE LEFT EYE. THE PATIENT''S UCVA IS 20/40 IN EACH EYE.

    Description of Event or Problem · 1

    THE DOCTOR REPORTED THAT A LASER VISION CORRECTION PATIENT PRESENTED AT THE ONE MONTH POST OP EXAMINATION WITH AN UNDERCORRECTION IN BOTH EYES FOLLOWING A LASER PRK TREATMENT. THE PATIENT''S POST OP BCVA IS 20/25 IN THE RIGHT EYE AND 20/30 IN THE LEFT EYE. THE PATIENT'S UCVA IS 20/40 IN EACH EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54400 STAR S4-IR-ETL EXCIMER LASER EXCIMER LASER LZS ABBOTT MEDICAL OPTICS S4-IR-ETL

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Other