BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FEMTOSECOND LASER

    MDR report key: 11824770 · Received May 14, 2021

    Report

    Report Number
    3006695864-2021-07724
    Event Type
    Injury
    Date Received
    May 14, 2021
    Report Date
    May 14, 2021
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    GEX
    PMA / PMN Number
    K141852
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: EXACT DATES NOT PROVIDED, ARTICLE RECEIVED DATE IS APR 16, 2021. DEVICE EVALUATION: THE PRODUCT TESTING COULD NOT BE PERFORMED AS THE PRODUCT WAS NOT RETURNED. THE REPORTED COMPLAINT CANNOT BE CONFIRMED. MANUFACTURING RECORD EVALUATION: THE MANUFACTURING RECORD REVIEW COULD NOT BE PERFORMED BECAUSE THE SERIAL NUMBER OF THE COMPLAINT PRODUCT IS UNKNOWN. SINCE THE SERIAL NUMBER IS UNKNOWN, THE COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED. CONCLUSION: SINCE THE SAMPLE OF THE COMPLAINT PRODUCT WAS NOT RETURNED, AND SERIAL NUMBER IS UNKNOWN, IT IS NOT POSSIBLE TO DETERMINE A MALFUNCTION AND/OR PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    ARTICLE: VECTOR ANALYSIS OF FEMTOSECOND LASER-ASSISTED ASTIGMATIC KERATOTOMY AFTER DEEP ANTERIOR LAMELLAR KERATOPLASTY AND PENETRATING KERATOPLASTY. A RETROSPECTIVE, COMPARATIVE, INTERVENTIONAL STUDY WAS DONE TO COMPARE THE REFRACTIVE AND KERATOMETRIC CHANGES INDUCED BY FEMTOSECOND LASER ASTIGMATIC KERATOTOMY (AK) FOR SUTURE-OUT POST-KERATOPLASTY ASTIGMATISM IN DEEP ANTERIOR LAMELLAR KERATOPLASTY AND PENETRATING KERATOPLASTY. A TOTAL OF 50 PATIENTS UNDERWENT FEMTOSECOND AK FOR SUTURE-OUT POST-KERATOPLASTY ASTIGMATISM AND WERE DIVIDED INTO TWO GROUPS: PATIENTS WHO UNDERWENT DEEP ANTERIOR LAMELLAR KERATOPLASTY (N=15; GROUP I) AND PATIENTS WHO UNDERWENT PENETRATING KERATOPLASTY (N=35; GROUP II). ASTIGMATIC KERATOTOMY WAS PERFORMED WITH THE IFS LASER (ADVANCED MEDICAL OPTICS, INC.). TWO CASES IN GROUP I HAD AN INCREASE IN ASTIGMATISM (N=2). IN GROUP II, FAILED GRAFT OCCURRED IN ONE EYE (N=1) ONE-YEAR POST-FEMTOSECOND LASER AK IN WHICH THE PATIENT UNDERWENT DEEP ANTERIOR LAMELLAR KERATOPLASTY FOLLOWED BY PHOTOREFRACTIVE KERATECTOMY AS TREATMENT. FURTHER INTERVENTIONS WERE NOT REPORTED A COPY OF THE ARTICLE IS PROVIDED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723147 INTRALASE FEMTOSECOND LASER INTRALASE FEMTOSECOND LASER GEX AMO MANUFACTURING USA, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention