BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 7398497 · Received April 5, 2018

    Report

    Report Number
    3006695864-2018-00692
    Event Type
    Injury
    Date Received
    April 5, 2018
    Date of Event
    March 2, 2018
    Report Date
    May 22, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ACCOUNT REPORTED THAT PATIENT IS STILL EXPERIENCING BLURRY VISION WITH CENTRAL HAZE ON (B)(6) 2018. DURING FOLLOW UP APPOINTMENT ON (B)(6) 2018 BEST CORRECTED VISUAL ACUITY (BCVA) WAS 20/40 AND THERE WAS NO HAZE. CONDITION IS IMPROVING AND VISION IS STABLE. BCVA FROM (B)(6) 2018. RIGHT EYE POST-OP 20/50 -.50 X -1.25 X 72; LEFT EYE POST-OP 20/15 .00 X .00 X 90. SURGEON REPORTED THAT WILL CONTINUE TO FOLLOW UP PATIENT AS CONDITION TAKES APPROXIMATELY 1 YEAR TO HEAL. ALSO 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 MITIGATION 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

    (B)(4). 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. 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 CENTRAL TOXIC KERATOPATHY IN RIGHT EYE. THE SURGEON WAS CONSULTED AND RECOMMENDED DISCONTINUING THE PRED-GATI 4 TIMES A DAY AND START LOTEMAX GEL 4 TIMES A DAY, MURO128 SOLUTION 4 TIMES A DAY AND MURO128 UNGUENT AT BEDTIME IN THE RIGHT EYE. THE PATIENT RAN OUT OF THE LOTEMAX GEL TWO WEEKS LATER BUT CONTINUED TO USE THE MURO 128 SOLUTION AND GEL. THE PATIENT IS NOW PREGNANT AND WILL NOT RESUME THE LOTEMAX GEL BUT WILL CONTINUE TO USE THE MURO 128 SOLUTION AND GEL. SHE WILL RETURN FOR FOLLOW-UP IN ONE MONTH. THE TOPICAL STEROID DOSAGE WAS INCREASED. IT WAS STATED THAT THE PATIENT HAD LOSS OF BEST CORRECTED VISUAL ACUITY (BCVA). THE PATIENT COMPLAINED OF BLURRED VISION. PATIENT REPORTED SYMPTOMS ARE INTERFERING WITH DAILY ACTIVITIES. BCVA FROM (B)(6) 2018. RIGHT EYE PRE-OP 20/20 -4.50 X -1.00 X 170. LEFT EYE PRE-OP 20/20 -4.25 X -1.00 X 5. BCVA FROM (B)(6) 2018. RIGHT EYE POST-OP 20/40. LEFT EYE POST-OP 20/10.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241886 INTRALASE FS2 FEMTOSECOND LASER HNO JOHNSON & JOHNSON SURGICAL VISION, INC 20003D

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention WAVELIGHT (B)(4)| WAVELIGHT (B)(4)