BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S4-IR-ETL

    MDR report key: 6947042 · Received October 12, 2017

    Report

    Report Number
    3006695864-2017-00888
    Event Type
    Injury
    Date Received
    October 12, 2017
    Date of Event
    August 9, 2017
    Report Date
    December 5, 2017
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    LZS
    UDI-DI
    05050474573413
    PMA / PMN Number
    P930016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A RECORD REVIEW WAS PERFORMED. A PRODUCT DEFICIENCY REVIEW WAS PERFORMED AND THERE IS NO PRODUCT DEFICIENCY IDENTIFIED. A DOCUMENT, SERVICE HISTORY, AND TRENDING WAS REVIEWED. THERE IS NOT A RECOGNIZABLE ADVERSE TREND. THE RISKS AND MITIGATIONS ASSOCIATED WITH THE COMPLAINT ISSUE ARE IDENTIFIED IN EXISTING RISK DOCUMENTS AND NO NEW RISKS WERE IDENTIFIED AS PART OF THIS INVESTIGATION. A LABELING REVIEW WAS CONDUCTED; THE OPERATOR MANUAL FOR THE SYSTEM WAS REVIEWED AND FOUND TO INCLUDE ADEQUATE INSTRUCTIONS FOR USE, WARNINGS AND OPERATIONAL ERRORS. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRESENTED FOR THE 3 MONTH POST OP VISIT ON (B)(6) 2017 WITH MILD HAZE IN BOTH EYES. THE HAZE WAS ABOVE AND BELOW THE VISUAL AXES. AT THE 6 MONTHS POST OP VISIT ON (B)(6) 2017 THE HAZE APPEARED MORE DENSE BUT WAS STILL LOCATED ONLY ABOVE AND BELOW THE VISUAL AXIX AND WAS AGAIN NOT CONSIDERED TO BE VISUALLY SIGNIFICANT AS UNCORRECTED VISUAL ACUITY WAS 20/16 IN RIGHT EYE AND 2016 IN LEFT EYE (20/13 BOTH EYES). AT THAT VISIT, THE SUBJECT WAS TREATED WITH FML EVERY 2 HOURS FOR 2 WEEKS. THE SUBJECT WAS SEEN ON THE (B)(6) AND PLACED ON A 6 WEEK FML TAPER ON THAT LAST VISIT. SUBJECT WAS SCHEDULED FOR (B)(6) 2017 BUT DID NOT ATTEND. THIS REPORT IS FOR THE VISX SYSTEM. A SEPARATE REPORT IS BEING SUBMITTED FOR THE IDESIGN SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724361 S4-IR-ETL EXCIMER LASER LZS ABBOTT MEDICAL OPTICS 0030-4864 05050474573413

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention