BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 7233334 · Received January 31, 2018

    Report

    Report Number
    3006695864-2018-00179
    Event Type
    Injury
    Date Received
    January 31, 2018
    Date of Event
    December 8, 2017
    Report Date
    March 5, 2018
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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 JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    THE SURGERY CENTER REPORTED THAT A LASER VISION CORRECTION PATIENT PRESENTED WITH AN ABNORMALITY UNDER THE FLAP ON THE LEFT EYE (OS) AT A POST-OPERATIVE EXAM. THE DAY OF INITIAL TREATMENT WAS ON (B)(6) 2017 AND THE DATE OF DISCOVERY WAS ON (B)(6) 2017. THE PATIENT¿S CHIEF COMPLAINT WAS OF IRREGULAR ASTIGMATISM. THE PATIENT HAD COMMENTED ON FUZZY VISION AND WEIRD SHADOW. TOPICAL STEROID DOSAGE WAS INCREASED AND A FLAP LIFT AND RINSE WAS PERFORMED TO RESOLVE SYMPTOMS. BEST CORRECTED VISUAL ACUITY (BCVA) FROM (B)(6) 2017: RIGHT EYE PRE-OP 20/20 -5.25 X .00 X 90, LEFT EYE PRE-OP 20/20 -5.50 X -.25 X 100. BCVA FROM (B)(6) 2017: RIGHT EYE POST-OP 20/20 -.25 X -.25 X 13, LEFT EYE POST-OP 20/20 3.50 X -4.75 X 128.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76612 INTRALASE FS2 FEMTOSECOND LASER HNO ABBOTT MEDICAL OPTICS 20003D

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention