BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 6927553 · Received October 7, 2017

    Report

    Report Number
    3005675890-2017-00062
    Event Type
    Injury
    Date Received
    October 7, 2017
    Date of Event
    June 26, 2017
    Report Date
    November 21, 2017
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 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

    THE SURGERY CENTER REPORTED THAT A LASER VISION CORRECTION PATIENT PRESENTED A FIBER UNDER THE LASIK RIGHT EYE FLAP AT A ONE MONTH POST OP EXAM. THE PATIENT COMPLAINED OF BLURRY DISTANCE VISION ON RIGHT EYE AND SEES A SPEC ON RIGHT EYE IN MIRROR. THE FLAP WAS RINSED AND LIFTED TO RESOLVE ISSUE. IT WAS REPORTED THAT PATIENT SYMPTOMS RESOLVED ON (B)(6) 2017. BCVA FROM (B)(6) 2017. RIGHT EYE PRE-OP 20/20 -3.25 X -.75 X 0. LEFT EYE PRE-OP 20/20 -3.50 X -.75 X 9.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707332 INTRALASE FS2 FEMTOSECOND LASER HNO ABBOTT MEDICAL OPTICS 20003D

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Required Intervention