BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IFS ADVANCED FEMTOSEC LASER

    MDR report key: 14639279 · Received June 8, 2022

    Report

    Report Number
    3012236936-2022-01507
    Event Type
    Injury
    Date Received
    June 8, 2022
    Date of Event
    June 3, 2021
    Report Date
    June 8, 2022
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    GEX
    UDI-DI
    05050474573468
    PMA / PMN Number
    K141852
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF PUBLICATION USED FOR DATE OF EVENT (B)(6) 2021. A REVIEW OF THE RECORDS RELATED TO THE DEVICE THAT INCLUDED LABELING, MANUALS, TRENDING, AND RISK DOCUMENTATION REVIEWS WAS PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) SHOWED THAT THE SYSTEM AND ITS COMPONENTS MET ALL SPECIFICATIONS PRIOR TO BEING RELEASED. 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. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON HAS BEEN SUBMITTED. CITATION: MOSHIRFAR, M., WEST, D. G., MILLER, C. M., WEST, W. B., MCCABE, S. E., SHMUNES, K. M., BAKER, P. A., RONQUILLO, Y. C., & HOOPES, P. C. (2021). INCIDENCE, RISK, AND VISUAL OUTCOMES AFTER REPOSITIONING OF ACUTE NON-TRAUMATIC FLAP DISLOCATIONS FOLLOWING FEMTOSECOND-ASSISTED LASIK. JOURNAL OF CLINICAL MEDICINE, 10(11), 2478. HTTPS://DOI.ORG/10.3390/JCM10112478.

    Description of Event or Problem · 0

    LITERATURE ARTICLE TITLE INCIDENCE, RISK, AND VISUAL OUTCOMES AFTER REPOSITIONING OF ACUTE NON-TRAUMATIC FLAP DISLOCATIONS FOLLOWING FEMTOSECOND-ASSISTED LASIK. A RETROSPECTIVE STUDY WAS DONE TO ANALYZE THE INCIDENCE AND OUTCOMES OF FLAP REPOSITIONING (FR) FOR ACUTE FLAP DISLOCATION AND VISUALLY SIGNIFICANT STRIAE IN PATIENTS UNDERGOING FEMTOSECOND LASER-ASSISTED LASIK (FS-LASIK). FROM A TOTAL OF 21,536 EYES THAT UNDERWENT FS-LASIK WITH EITHER WAVELIGHT FS200 (ALCON LABORATORIES), ZEISS VISUMAX (CARL ZEISS MEDITEC, INC.) OR AMO IFS (JOHNSON & JOHNSON VISION), 70 EYES REQUIRED FR DUE TO POST-OPERATIVE COMPLICATIONS (FLAP DISLOCATION N=25 EYES; STRIAE N=45 EYES). AMONG THE 70 EYES THAT UNDERWENT FR, 59 EYES USED AMO IFS FOR FEMTOSECOND FLAP CREATION. IT WAS REPORTED THAT 8.6% OF EYES HAVE 3 OR MORE WORSE UNCORRECTED DISTANCE VISUAL ACUITY (UDVA), 6.9% OF EYES WITH 2 WORSE UDVA, AND 16% OF THE EYES WITH 1 WORSE UDVA. FURTHERMORE, FOUR EYES (5.7%) LOST ONE OR MORE SNELLEN LINES OF CORRECTED DISTANCE VISUAL ACUITY (CDVA), WITH ONE EYE LOSING TWO LINES OF CDVA AND THREE EYES LOSING ONE LINE OF CDVA. IT WAS ALSO REPORTED THAT A LARGE ANGLE OF ERROR OF REFRACTIVE ASTIGMATISM WAS FOUND IN THREE OUT OF FOUR OF THESE EYES, WHICH COULD ACCOUNT FOR THE REDUCTION IN PERCEIVED CDVA. IT IS NOT CLEAR WHETHER THESE EVENTS WERE ATTRIBUTED WITH THE USE OF THE J&J DEVICE/S OR COMPETITOR PRODUCTS. FURTHER TREATMENT WAS NOT REPORTED. FOUR EYES (5.7%) LOST ONE OR MORE SNELLEN LINES OF CDVA, WITH ONE EYE LOSING TWO LINES OF CDVA AND THREE EYES LOSING ONE LINE OF CDVA. OF THESE FOUR EYES, TWO HAD A PREOPERATIVE CDVA OF 20/15 WITH A POSTOPERATIVE CDVA OF 20/20. HOWEVER, IT IS IMPORTANT TO NOTE THAT THE EXAMINER MAY NOT ALWAYS CHECK BEYOND THE 20/20 SNELLEN LINE, WHICH COULD ACCOUNT FOR THE APPARENT REDUCTION IN CDVA IN EYES WITH A PREOPERATIVE CDVA OF 20/15.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2421406 IFS ADVANCED FEMTOSEC LASER POWERED LASER SURGICAL INSTRUMENT GEX AMO MANUFACTURING USA, LLC J20007D 05050474573468

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other| R