BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 7528590 · Received May 20, 2018

    Report

    Report Number
    3006695864-2018-01120
    Event Type
    Injury
    Date Received
    May 20, 2018
    Date of Event
    April 20, 2018
    Report Date
    June 12, 2018
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF RECORDS RELATED TO THE DEVICE INCLUDING COMPLAINT TRENDING, AND RISK DOCUMENTATION WILL BE PERFORMED. UPON COMPLETION OF THIS REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    IN INITIAL REPORT, IT WAS INDICATED THERE WAS NO ADDITIONAL INFORMATION PROVIDED, HOWEVER, ADDITIONAL INFORMATION WAS PROVIDED THAT STRIAE WAS THE ISSUE REPORTED AND WAS INCLUDED IN THE INITIAL REPORT. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LASER VISION CORRECTION PATIENT HAD SURGERY ON (B)(6) 2018 AND ON (B)(6) 2018 WAS PRESENTED WITH STRIAE. A FLAP LIFT AND IRRIGATION WAS PERFORMED IN THE RIGHT EYE (OD) POST TREATMENT. IT WAS STATED THAT THE PATIENT HAD NO LOSS OF BEST CORRECTED VISUAL ACUITY (BCVA). PATIENT REPORTED THE SYMPTOMS ARE NOT INTERFERING WITH DAILY ACTIVITIES. ALTHOUGH ATTEMPTS WERE MADE FOR ADDITIONAL INFORMATION, NONE HAS BEEN PROVIDED. BCVA FROM (B)(6) 2018: RIGHT EYE PRE-OP 20/20 -.75 X-.50 X 4, LEFT EYE PRE-OP 20/20 -1.00 X -.25 X 9. THIS REPORT IS FOR THE FEMTO LASER EQUIPMENT. A SEPARATE REPORT WILL BE FILED FOR THE EXCIMER LASER EQUIPMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371043 INTRALASE FS2 FEMTOSECOND LASER HNO JOHNSON & JOHNSON SURGICAL VISION, INC 20003D

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention