BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_INTRALASE FS1_FEMTOSECOND LASER

    MDR report key: 19316233 · Received May 14, 2024

    Report

    Report Number
    3012236936-2024-000139
    Event Type
    Injury
    Date Received
    May 14, 2024
    Date of Event
    January 11, 2022
    Report Date
    May 14, 2024
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    HNO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UNKNOWN/NOT PROVIDED DATE OF PUBLICATION USED AS DATE OF EVENT. JANUARY 11, 2022 THE DEVICE WAS NOT AVAILABLE FOR EVALUATION. THE SERIAL NUMBER FOR THE DEVICE WAS NOT PROVIDED; THEREFORE, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF THERE IS ANY FURTHER RELEVANT INFORMATION RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. CITATION: PEDRO BERTINO, MD, ARTICLE: INTRASTROMAL CORNEAL RING SEGMENTS FOLLOWED BY PRK FOR POST KERATOPLASTY HIGH ASTIGMATISM: PROSPECTIVE STUDY J CATARACT REFRACT SURG 2022; 48: 912¿923. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    THE FOLLOWING ARTICLE WAS RECEIVED BASED ON A LITERATURE REVIEW: A PROSPECTIVE INTERVENTIONAL STUDY WAS DONE TO EVALUATE REFRACTIVE AND TOPOGRAPHIC RESULTS OF THE ASSOCIATION OF INTRASTROMAL CORNEAL RING SEGMENTS (ICRS) WITH PHOTOREFRACTIVE KERATECTOMY (PRK) FOR THE CORRECTION OF HIGH (>6.0 DIOPTERS [D]) POSTKERATOPLASTY ASTIGMATISM (PKA). A TOTAL OF 30 EYES OF 29 WHO WERE INTOLERANT TO CONTACT LENS FITTING, AND WITH CORNEAL ASTIGMATISM HIGHER THAN 6.0 D WERE TREATED BY THE COMBINATION OF ICRS AND PRK. ALL PATIENTS UNDERWENT FEMTOSECOND LASER¿ASSISTED (INTRALASE FS 60KHZ; ABBOTT MEDICAL OPTICS, INC.) IMPLANTATION OF ICRS (FERRARA RING; AJL OPHTHALMIC S.A.). THERE WERE 3 CASES OF ENDOTHELIAL PERFORATION DURING ICRS TUNNEL CREATION. IN ALL THESE 3 EYES, THE PROCEDURE WAS POSTPONED FOR 30 DAYS AND THEN PERFORMED UNEVENTFULLY. THERE ARE NO INDICATIONS IN THE ARTICLE OF ANY INTERVENTIONS PROVIDED. OTHER JNJ PRODUCTS WERE MENTIONED BUT NO COMPLAINTS WERE REPORTED AGAINST THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    488633 UNK_INTRALASE FS1_FEMTOSECOND LASER FEMTOSECOND LASER HNO AMO MANUFACTURING USA, LLC UNK-INTRALASE

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other