BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IFS ADVANCED FEMTOSEC LASER

    MDR report key: 14644095 · Received June 9, 2022

    Report

    Report Number
    3012236936-2022-01517
    Event Type
    Injury
    Date Received
    June 9, 2022
    Date of Event
    August 24, 2021
    Report Date
    June 9, 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

    AGE OR DATE OF BIRTH, WEIGHT, ETHNICITY: UNKNOWN/ NOT PROVIDED. DATE OF PUBLICATION USED FOR DATE OF EVENT AUGUST 24, 2021. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION HAS BEEN SUBMITTED. CITATION: MOSHIRFAR, M., HUYNH, R., BUNDOGJI, N., TUKAN, A. N., SANT, T. M., MCCABE, S. E., WEST, W. B., DRENNAN, K., RONQUILLO, Y. C., & HOOPES, P. C. (2021). COMPARISON OF 6.0 MM VERSUS 6.5 MM OPTICAL ZONE ON VISUAL OUTCOMES AFTER LASIK. JOURNAL OF CLINICAL MEDICINE, 10(17), 3776. HTTPS://DOI.ORG/10.3390/JCM10173776.

    Description of Event or Problem · 0

    A RETROSPECTIVE STUDY WAS DONE TO EVALUATE THE VISUAL OUTCOMES IN POST-LASER IN SITU KERATOMILEUSIS (LASIK) EYES TO COMPARE THE PREDICTABILITY, EFFICACY, AND SAFETY OF THE WL EX500 USING 6.0 MM AND 6.5 MM OPTICAL ZONES WITH A 1.25 MM BLEND ZONE. THE IFS INTRALASE (IFS® ADVANCED FEMTOSECOND LASER, JOHNSON AND JOHNSON VISION, USA) WAS USED TO CREATE FLAPS, FOLLOWED BY TREATMENT WITH WL EX500 LASER FOR ALL PATIENTS INCLUDED IN THIS STUDY. A 6.0 MM (N=1332 PATIENTS/EYES) OR 6.5 MM (N=1332 PATIENTS/EYES) OPTICAL ZONE WAS CHOSEN BASED ON RANDOM SELECTION. PATIENTS WERE FURTHER STRATIFIED BASED ON SEVERITY OF MYOPIA (LOW, MODERATE, AND HIGH) AND ASTIGMATISM (LOW AND HIGH). A SUBSET OF EYES FROM THE 6.0 MM (N = 250 PATIENTS) AND 6.5 MM (N = 250 PATIENTS) OPTICAL ZONE GROUPS WERE RETROSPECTIVELY ASSESSED FOR SUBJECTIVE SYMPTOMS OF DRY EYES, GLARE/HALOS, AND OVERALL SATISFACTION FOLLOWING LASIK DOCUMENTED AT ANY POINT PREOPERATIVELY AND WITHIN THE 1-YEAR FOLLOW-UP PERIOD WITHIN THEIR CHARTS. THE REPORTED OUTCOMES WERE: POSTOPERATIVE GLARE AND HALOS: MILD: N=19 (6.0 MM GROUP) AND N=11 (6.5MM GROUP), MODERATE: N=2 (6.0 MM GROUP) AND N=3 (6.5 MM GROUP), SEVERE: N=1 (6.0 MM GROUP). POSTOPERATIVE DRYNESS SYMPTOMS: MILD: N=91 (6.0 MM GROUP) AND N=92 (6.5MM GROUP), MODERATE: N=3 (6.0 MM GROUP) AND N=1 (6.5 MM GROUP). POSTOPERATIVE SUPERFICIAL PUNCTATE KERATITIS (SPK) SYMPTOMS: MILD: N=12 (6.0 MM GROUP) AND N=12 (6.5MM GROUP). MODERATE: N=1 (6.5 MM GROUP). DIFFERENCES BETWEEN UDVA AND CDVA: 3 OR MORE WORSE = 2% OF THE 6.0 MM GROUP, 2 WORSE = 2% OF 6.0 MM AND 6.5% MM GROUPS, 1 WORSE = 9% OF BOTH 6.0 MM AND 6.5 MM GROUPS. CHANGE IN SNELLEN CDVA: LOSS OF 1 LINE = 2% FOR THE 6.0 MM GROUP AND 4% FOR THE 6,5 MM GROUP. ASTIGMATIC CORRECTION AND POSTOPERATIVE ANGLE OF ERROR WERE SIMILAR BETWEEN OPTICAL ZONE SIZES BUT WERE SIGNIFICANTLY WORSE WITH HIGH MYOPIA. OF EYES CATEGORIZED AS MODERATE MYOPIA, THE 6.0 MM GROUP WAS SIGNIFICANTLY MORE MYOPIC POSTOPERATIVELY (MRSE -0.18±0.39 D; SPHERE -0.04 ±_0.38 D). YES TO ENHANCEMENT: N=12 (6.0 MM GROUP) AND N=3 (6.5MM GROUP). 0.4% OF PATIENTS IN THE 6.0 MM GROUP WERE ¿UNHAPPY¿ WITH THEIR VISUAL OUTCOME. THERE WERE NO FURTHER INTERVENTIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2420586 IFS ADVANCED FEMTOSEC LASER POWERED LASER SURGICAL INSTRUMENT GEX AMO MANUFACTURING USA, LLC J20007D 05050474573468

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other