BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 7339488 · Received March 14, 2018

    Report

    Report Number
    3006695864-2018-00525
    Event Type
    Injury
    Date Received
    March 14, 2018
    Date of Event
    February 14, 2018
    Report Date
    April 14, 2018
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    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 NO 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 SURGERY CENTER REPORTED THAT A LASER VISION CORRECTION PATIENT EXPERIENCED BLURRY VISION ON BOTH EYES (OU) ON A 1-MONTH POST-OP EXAM. A BRIEF DESCRIPTION FROM THE SURGERY CENTER INDICATED THE PATIENT HAD BLURRED VISION WITH NO IMPROVEMENT SEEN AND IS CONSTANT WITH NO FLUCTUATIONS. THE SURGERY CENTER ALSO INDICATED THE PATIENT¿S NIGHT VISION IS WORSE AS WELL. THE PATIENT HAS STATED THAT WOULD LIKE THE LASER TREATMENT REVERSED. THE PATIENT¿S CHIEF COMPLAINT WAS OF BLURRED VISION AT A DISTANCE. THE SURGERY CENTER REPORTED THE EVENT IS LASTING AND DISABLING, SIGNIFICANTLY INTERFERING WITH DAILY ACTIVITIES. BCVA FROM (B)(6) 2018: RIGHT EYE POST-OP 20/25 -1.00X -.75 X 20, LEFT EYE POST-OP 20/20 .00 X -1.00 X 160.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183144 INTRALASE FS2 FEMTOSECOND LASER HNO JOHNSON & JOHNSON SURGICAL VISION, INC. 20003D

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other WAVELIGHT SERIAL (B)(4)