BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 7368916 · Received March 26, 2018

    Report

    Report Number
    3006695864-2018-00582
    Event Type
    Injury
    Date Received
    March 26, 2018
    Report Date
    April 25, 2018
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LASER EQUIPMENT WAS EXAMINED AND TESTED AT THE CUSTOMER LOCATION BY JOHNSON & JOHNSON APPLICATION SUPPORT MANAGER (ASM). THE ASM FOUND NO ISSUES AND INDICATED THE DEVICE AND SETTINGS WERE APPROPRIATE, HOWEVER, THE ASM ADJUSTED THE BED ENERGY SETTINGS TO MAKE LIFTS EASIER. THE ADJUSTED SETTING WAS NOT RELATED TO THE DLK REPORTED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    MANUFACTURER DATE IN INITIAL REPORT WAS INCORRECT AS YEAR SHOULD HAVE BEEN 2007. 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 PRESENTED WITH BILATERAL GRADE 3 OF DIFFUSE LAMELLAR KERATITIS (DLK). A FLAP LIFT AND RINSE WAS PERFORMED TO RESOLVE THE DLK. THE SURGERY CENTER REPORTED THE SYMPTOMS WERE RESOLVED WITHOUT VISION ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213423 INTRALASE FS2 FEMTOSECOND LASER HNO JOHNSON & JOHNSON SURGICAL VISION, INC 20003D

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention