BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 7371600 · Received March 26, 2018

    Report

    Report Number
    3006695864-2018-00595
    Event Type
    Injury
    Date Received
    March 26, 2018
    Date of Event
    February 23, 2018
    Report Date
    May 11, 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
    OTHER

    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

    FIELD SERVICE SPECIALIST (FSS) VISITED THE ACCOUNT AND CHECKED SYSTEM USING HIS TEST CONES AS THE SITE DID NOT SAVE ANY RELATED TO THE EVENT. HE MEASURED DEPTH IN GEL USING TEST CONES AND FOUND 130 AVERAGE FOR 120 TARGET (WITHIN SPECIFICATION). THEN FSS USED 3 CUSTOMER CONES THAT HAD BEEN USED. ON THE FIRST TWO CONES THE DEPTH WAS 128 (IN RANGE OF THE TEST CONES), THE THIRD CONE MEASURED 111 WHICH IS 20 MICRONS THIN AND NOT IN RANGE. THE CONES THAT HAD SUCTION ISSUES ARE FROM LOT# 60099531. (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENTS HAD LASIK PROCEDURE AND HAD VERTICAL GAS BREAKTHROUGH AND FLAP THICKNESS VARIANCES. THE SURGEON USED A BANDAGE CONTACT LENS POST OP. THE ACCOUNT CANNOT PROVIDE HOW MANY PATIENTS WERE AFFECTED. ALL PATIENTS HAD FLAP LIFTED AND EXCIMER TREATMENT WAS COMPLETED. NO PATIENT HAD UNEXPECTED OUTCOME OR NEEDED FURTHER MEDICAL INTERVENTION. NO PATIENT INTERFACE WAS SAVED. THIS REPORT IS FOR THE INTRALASE LASER. A SEPARATE REPORTS IS BEING SUBMITTED FOR THE PATIENT INTERFACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212406 INTRALASE FS2 FEMTOSECOND LASER HNO JOHNSON & JOHNSON SURGICAL VISION, INC 20003D

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PATIENT INTERFACE LOT UNK