BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 6896544 · Received September 27, 2017

    Report

    Report Number
    3006695864-2017-00802
    Event Type
    Injury
    Date Received
    September 27, 2017
    Date of Event
    September 1, 2017
    Report Date
    October 31, 2017
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HNO
    UDI-DI
    05050474573451
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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

    (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 TRANSIENT LIGHT SENSITIVITY IN BOTH EYES (OU) AT THE 3 MONTH POST-OPERATIVE EXAM. THE PATIENT¿S COMMENTS WERE DIFFICULT TO WORK AND DIFFICULTY KEEPING EYES OPEN. IT WAS INDICATED THAT THE EVENT WAS LASTING AND DISABLING, SIGNIFICANTLY INTERFERING WITH DAILY ACTIVITIES. TOPICAL STEROID DOSAGE WAS INCREASED TO TREAT THE SYMPTOMS. BCVA FROM (B)(6) 2017: RIGHT EYE PRE-OP 20/15 -5.50 X -.75 X 0, LEFT EYE PRE-OP 20/15 -5.50 X -1.25 X 0. ON (B)(6) 2017 UNCORRECTED VISUAL ACUITY (UCVA) 20/20.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    676255 INTRALASE FS2 FEMTOSECOND LASER HNO ABBOTT MEDICAL OPTICS 20005D 05050474573451

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention WAVELIGHT SERIAL NO. (B)(4)