BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 7447521 · Received April 20, 2018

    Report

    Report Number
    3006695864-2018-00838
    Event Type
    Injury
    Date Received
    April 20, 2018
    Date of Event
    March 21, 2018
    Report Date
    April 20, 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
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF RECORDS RELATED TO THE DEVICE INCLUDING LABELING, 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. (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 A LASER VISION CORRECTION PATIENT HAD SURGERY ON (B)(6) 2018 AND PRESENTED ON (B)(6) 2018 WITH RHEGMATOGENOUS RETINAL DETACHMENT (RRD) IN RIGHT EYE. IT WAS STATED THAT THE PATIENT HAD LOSS OF BEST CORRECTED VISUAL ACUITY (BCVA). THE PATIENT COMPLAINED OF RESTRICTED NASAL VISUAL FIELD IN RIGHT EYE WITH FLASHES AND FLOATERS. PATIENT REPORTED SYMPTOMS ARE INTERFERING WITH DAILY ACTIVITIES AND WAS REFERRED TO A RETINAL SPECIALIST. BCVA FROM (B)(6) 2018: RIGHT EYE PRE-OP 20/20 -5.25 X -1.50 X 7, LEFT EYE PRE-OP 20/20 -6.50 X -.50 X 9. BCVA FROM (B)(6) 2018: RIGHT EYE POST-OP 20/150 .00 X .00 X 90, LEFT EYE POST-OP 20/20 .25 X -.75 X 168.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290545 INTRALASE FS2 FEMTOSECOND LASER HNO JOHNSON & JOHNSON SURGICAL VISION, INC 20005D 05050474573451

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other WAVELIGHT (B)(4)