BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 7322182 · Received March 7, 2018

    Report

    Report Number
    3006695864-2018-00454
    Event Type
    Injury
    Date Received
    March 7, 2018
    Date of Event
    February 3, 2018
    Report Date
    April 6, 2018
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC
    Product Code
    HNO
    UDI-DI
    05050474573451
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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 JOHNSON & JOHNSON SURGICAL VISION, INC HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SURGEON HAD 2 EYES THAT PRESENTED WITH DIFFUSE LAMELLAR KERATITIS (DLK) GRADE 1+ POST SURGERY. THE SURGEON DID NOT CLARIFY IF THE EYES BELONGED TO THE SAME PATIENT OR IF THEY BELONGED TO DIFFERENT PATIENTS. SURGEON INCREASED THE TOPICAL STEROID DROPS EVERY 1-2 HRS FOR 2 DAYS AND DLK WAS RESOLVED AT LAST VISIT. NO LOSS OF BEST CORRECTED VISUAL ACUITY REPORTED. SEVERAL ATTEMPTS TO CLARIFY WITH THE ACCOUNT IF MORE THAN ONE PATIENT WAS INVOLVED HOWEVER, NO ADDITIONAL INFO HAD BEEN PROVIDED AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164099 INTRALASE FS2 FEMTOSECOND LASER HNO JOHNSON & JOHNSON SURGICAL VISION, INC 20005D 05050474573451

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention