BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FS LASER SYSTEM

    MDR report key: 21565568 · Received March 10, 2025

    Report

    Report Number
    3012236936-2025-000069
    Event Type
    Injury
    Date Received
    March 10, 2025
    Date of Event
    January 23, 2025
    Report Date
    April 11, 2025
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    GEX
    UDI-DI
    05050474573451
    PMA / PMN Number
    K063682
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: SALES REP DISCUSSED LASER ENERGY SETTINGS WITH SURGEON WHO REPORTED THAT EVENT WAS NOT LASER RELATED. A REVIEW OF THE DEVICE HISTORY RECORD, COMPLAINT TRENDING, AND RISK DOCUMENTATION FOR THIS DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. CONCLUSION: AS A RESULT OF THE INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTION: SECTION H6 TYPE OF INVESTIGATION: IN THE INITIAL REPORT CODE WAS SUBMITTED AS #10 HOWEVER, THE CORRECT CODE IS #4114. ADDITIONAL INFORMATION: MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE DEVICE WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT FROM CASE DAY ON (B)(6) 2025 PRESENTED WITH DIFFUSE LAMELLAR KERATITIS (DLK) BOTH EYES (OU) ON DAY 1 POST OP. PATIENT VISION WAS 20/200 OU. SURGEON STARTED PATIENT WITH STEROID DROP EVERY 2 HOURS FOR 24 HOURS AND THEN STARTED ON ORAL STEROID FOR A 14 DAY TAPER DOSE. SURGEON SAW PATIENT ON (B)(6) 2025 AND LEFT EYE (OS) INFLAMMATION APPEARED TO RESOLVE BUT RIGHT EYE (OD) STILL PRESENTED WITH MILD INFLAMMATION AND WAS CONTINUING WITH STEROID DROPS EVERY 4 HOURS. ON (B)(6) 2025 VISIT OS VISION WAS 20/20 AND OD WAS 20/40. SURGEON WILL SEE PATIENT IN TWO WEEKS AND WILL PROVIDE UPDATE IF FURTHER TREATMENT IS NEEDED. LASER ENERGY SETTINGS WERE DISCUSSED WITH SURGEON AND SURGEON STATED THAT SHE DOESN'T FEEL IT IS LASER INVOLVEMENT BUT FEELS THAT IT IS PATIENT SPECIFIC AS HE HAD OTHER HEALTH RELATED ISSUES AROUND THE SAME TIME, HE HAD THE LASIK PROCEDURE. ADDITIONAL INFORMATION RECEIVED: PRE LASIK-VISUAL ACUITY (VA): SANS CORRECTED; OD 20/350, OS 20/300, OU 20/300, WITH CORRECTION DVO¿S; OD 20/20 OS 20/20-1 OU 20/20. POST LASIK VA 1 DAY; OD 20/60, OS 20/25-1, OU 20/20, 2 DAY; OD 20/250, OS 20/25+2, STARTED ON ORAL PRED, 3 DAY; OD 20/60-2, OS 20/20, 5 DAY; OD 20/25-1, OS 20/25-1, 8 DAY; OD 20/60, OD 20/25, OU 20/30+3, 12 DAY; OD 20/50, OS 20/25, OU 20/30, TAPERING ORAL PRED, 19 DAY; OD 20/50, OS 20/25-2, OU 20/20-2, 1 MONTH; OD 20/50, OS 20/70, OU 20/30, RECURRENCE OF DEFECT, RESTART ORAL PRED, 1 MONTH 1 DAY; OD 20/40+1, OS 20/40+1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2091757 FS LASER SYSTEM POWERED LASER SURGICAL INSTRUMENT GEX AMO MANUFACTURING USA, LLC 20005D 05050474573451

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Male Required Intervention