BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 7153157 · Received December 28, 2017

    Report

    Report Number
    3006695864-2017-01421
    Event Type
    Injury
    Date Received
    December 28, 2017
    Date of Event
    November 30, 2017
    Report Date
    March 14, 2018
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS 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 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. IN THE INITIAL REPORT IT WAS REPORTED THAT THE MANUFACTURING DATE FOR THE SYSTEM WAS 10/31/2006 HOWEVER, THE MANUFACTURING SITE HAS PROVIDED THE DATE AS 2007 (ONLY YEAR PROVIDED). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT THE START OF THE TREATMENT THE DOCTOR NOTICED A LARGE BUBBLE NEAR THE POCKET ON THE LEFT EYE. SURGEON STOPPED PROCEDURE AND STATED THIS WAS A VERTICAL GAS BREAKTHOUGH AND DID NOT COMPLETE THE LEFT EYE. PROCEDURE WAS SUCCESSFULLY COMPLETED ON THE RIGHT EYE. SURGEON STATED THAT HE WOULD DETERMINE HOW TO PROCEED. FLAP DEPTH WAS PROGRAMMED AT 100 UM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    931602 INTRALASE FS2 FEMTOSECOND LASER HNO ABBOTT MEDICAL OPTICS 20003D

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention