BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 7186422 · Received January 12, 2018

    Report

    Report Number
    3006695864-2018-00075
    Event Type
    Injury
    Date Received
    January 12, 2018
    Date of Event
    December 27, 2017
    Report Date
    March 6, 2018
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    THE CLINIC REPORTED THAT A LASER VISION CORRECTION PATIENT HAD SURGERY ON (B)(6) 2017 AND PRESENTED ON (B)(6) 2017 WITH EPITHELIAL INGROWTH IN THE RIGHT EYE THAT WAS DISCOVERED DURING SLIT LAMP EXAM. A FLAP LIFT AND RINSE WAS SCHEDULED. IT WAS STATED THAT THE PATIENT HAD NO LOSS OF BEST CORRECTED VISUAL ACUITY (BCVA). THE PATIENT HAD NO COMPLAINTS. PATIENT REPORTED SYMPTOMS ARE NOT INTERFERING WITH DAILY ACTIVITIES. BCVA FROM (B)(6) 2017: RIGHT EYE PRE-OP 20/20 .75 X -1.25 X 108, LEFT EYE PRE-OP 20/20 .75 X -1.50 X 75. BCVA FROM (B)(6) 2017: RIGHT EYE POST-OP 20/20 .50 X -.75 X 25, LEFT EYE POST-OP 20/20 .00 X -.75 X 79. THIS REPORT IS FOR THE INTRALASE SYSTEM. A SEPARATE REPORT IS BEING SUBMITTED FOR THE VISX LASER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29705 INTRALASE FS2 FEMTOSECOND LASER HNO ABBOTT MEDICAL OPTICS 20003D

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention VISX 5475