BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KERATOME, AC-POWERED

    MDR report key: 11532523 · Received March 19, 2021

    Report

    Report Number
    3006695864-2021-07368
    Event Type
    Injury
    Date Received
    March 19, 2021
    Date of Event
    February 11, 2021
    Report Date
    March 19, 2021
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    HNO
    PMA / PMN Number
    K141852
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE OR DATE OF BIRTH, WEIGHT AND ETHNICITY: UNKNOWN, NOT PROVIDED. (B)(6). FIELD SERVICE ENGINEER SERVICED THE SYSTEM AND REPORTED THAT ON Z-CALIBRATION TEST, WAS FOUND -37 FOR -25 Z BASELINE, PERFORMING A FLAP OF 159 M FOR 120 M OF DEPTH. Z-CALIBRATION BASELINE WAS CORRECTED TO -25 M AND THE FLAP DEPTH MEASURE WAS 144 M. Z- CALIBRATION BASELINE WAS CORRECTED TO -15 M AND THE MEASURE FLAP DEPTH WAS 128 M. SYSTEM RELEASED FOR SURGERIES. A REVIEW OF THE RECORDS RELATED TO THIS EQUIPMENT THAT INCLUDED LABELING, MANUAL, AND RISK DOCUMENTATION REVIEWS FOR THIS EQUIPMENT WAS PERFORMED. EQUIPMENT LABELING PROVIDES POSSIBLE COMPLICATIONS THAT CAN BE CAUSED BY THE SURGICAL/TREATMENT PROCEDURE BEING PERFORMED. THE TREND REVIEW SHOWS THAT THERE IS NOT A 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 SURGICAL VISION HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE POSITIONING THE RING SEGMENT, IT MADE A PERFORATION THROUGH THE ENDOTHELIUM. NO OTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419685 KERATOME, AC-POWERED FEMTOSECOND LASER HNO AMO MANUFACTURING USA, LLC 20003K

    Patients

    Seq Age Sex Outcome Treatment
    1 Other