BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IFS ADVANCED FEMTOSEC LASER

    MDR report key: 14648310 · Received June 9, 2022

    Report

    Report Number
    3012236936-2022-01518
    Event Type
    Injury
    Date Received
    June 9, 2022
    Date of Event
    May 19, 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, SEX, WEIGHT, AND ETHNICITY: UNKNOWN/ NOT PROVIDED. DATE OF PUBLICATION USED AS DATE OF EVENT: MAY 19, 2021 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. CITATION: MOSHIRFAR, M., MEGERDICHIAN, A., WEST, W. B., MILLER, C. M., SPERRY, R. A., NEILSEN, C. D., TINGEY, M. T., & HOOPES, P. C. (2021). COMPARISON OF VISUAL OUTCOME AFTER HYPEROPIC LASIK USING A WAVEFRONT-OPTIMIZED PLATFORM VERSUS OTHER EXCIMER LASERS IN THE PAST TWO DECADES. OPHTHALMOLOGY AND THERAPY, 10(3), 547¿563. HTTPS://DOI.ORG/10.1007/S40123-021-00346-1.

    Description of Event or Problem · 0

    A ONE-CENTER, RETROSPECTIVE NON-COMPARATIVE STUDY WAS DONE TO ANALYZE THE REFRACTIVE OUTCOMES OF LASIK IN HYPEROPIA AND HYPEROPIC ASTIGMATIC EYES USING THE WAVE-FRONT OPTIMIZED LASER PLATFORM (THE ALLEGRETTO EX500 LASER) AND PERFORM A HISTORICAL COMPARISON WITH OTHER EXCIMER LASERS WITHIN THE PAST TWO DECADES. A TOTAL OF IN 265 PATIENTS (N= 379 EYES: N= 181 RIGHT EYES AND N= 198 LEFT EYES) WERE INCLUDED. LASER IN SITU KERATOMILEUSIS (LASIK) WAS PERFORMED THROUGH A STANDARD TECHNIQUE: A CORNEAL FLAP WAS CREATED USING THE INTRALASE IFS FEMTOSECOND LASER (JOHNSON AND JOHNSON, USA) THEN A CORNEAL ABLATION WAS PERFORMED USING THE ALLEGRETTO EX500 EXCIMER LASER WITH AN OPTICAL ZONE OF 6.00¿8.90 MM. AT 3 MONTHS POSTOPERATIVELY, AND ONLY FIVE (2.2%) OF THE 226 EYES LOST TWO OR MORE SNELLEN LINES. AT 1 YEAR POSTOPERATIVELY, ONLY TWO (1.1%) OF 189 EYES LOST TWO OR MORE SNELLEN LINES OF CORRECTED DISTANCE VISUAL ACUITY (CDVA). EYES WITH A NEGATIVE SPHERE AT BASELINE THAT WERE INCLUDED IN THE STUDY RECEIVED A HYPEROPIC ASTIGMATIC ABLATION AND WERE TREATED FOR THE PURPOSES OF MONOVISION AND THE INDUCTION OF ADDITIONAL MYOPIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2289872 IFS ADVANCED FEMTOSEC LASER POWERED LASER SURGICAL INSTRUMENT GEX AMO MANUFACTURING USA, LLC J20007D 05050474573468

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other