BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IFS

    MDR report key: 7238472 · Received February 2, 2018

    Report

    Report Number
    3006695864-2018-00185
    Event Type
    Injury
    Date Received
    February 2, 2018
    Date of Event
    January 5, 2018
    Report Date
    March 9, 2018
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HNO
    UDI-DI
    05050474573468
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FIELD SERVICE SPECIALIST VISITED THE ACCOUNT AND CHECKED SYSTEM. SYSTEM WAS OK AND PREVENTIVE MAINTENANCE WAS PERFORMED. COMPLETED FEMTO STANDARD SERVICE CALL CHECK LIST AND SYSTEM MEETS SPECIFICATIONS. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: A REVIEW OF THE RECORDS RELATED TO THE DEVICE THAT INCLUDED LABELING, MANUALS, TRENDING, AND RISK DOCUMENTATION WAS PERFORMED. THE TREND REVIEW SHOWS THAT THERE IS NOT SIGNIFICANT CHANGE OVER HISTORICAL COMPLAINT LIMITS AND NO 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. THERE WAS NO PRODUCT DEFICIENCY IDENTIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LASER VISION CORRECTION PATIENT HAD SURGERY ON (B)(6) 2018 AND PRESENTED ON (B)(6) 2018 WITH TRACE 1- 2+ CELL DIFFUSE LAMELLAR KERATITIS (DLK) IN BOTH (OU) EYES. THE TOPICAL STEROID DOSAGE WAS INCREASED UNTIL IT RESOLVED. IT WAS STATED THAT THE PATIENT HAD NO LOSS OF BEST CORRECTED VISUAL ACUITY (BCVA) AND NO SURGICAL INTERVENTION WAS PERFORMED. SURGEON REPORTED THAT ALL EYES NOTED TO HAVE DLK HAD BLEEDING DUE TO SMALL EYES AND BELIEVES THIS MAY HAVE BEEN A FACTOR. HE ALSO STATED THAT THE LIFTS WERE VERY EASY AND HE DROPPED HIS BED ENERGY FROM .90 TO .85. PATIENT POST OP UNCORRECTED VISUAL ACUITY (UCVA) 20/20 BOTH EYES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81880 IFS FEMTOSECOND LASER HNO ABBOTT MEDICAL OPTICS J20007D 05050474573468

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention