BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 19264979 · Received May 7, 2024

    Report

    Report Number
    3012236936-2024-000130
    Event Type
    Injury
    Date Received
    May 7, 2024
    Date of Event
    April 11, 2024
    Report Date
    June 20, 2024
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    GEX
    PMA / PMN Number
    K063682
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H11. ADDITIONAL NARRATIVE, SECTION H6, COMPONENT CODE, 896 - OSCILLATOR. SECTION H6, INVESTIGATION FINDINGS, 610 - LOSS OF POWER. THE MANUFACTURING RECORDS FOR THE DEVICE WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION A2, AND A4: REQUESTED BUT NOT PROVIDED. DEVICE EVALUATION: A FIELD SERVICE ENGINEER (FSE) WAS ONSITE TO PERFORM A SERVICE CHECK. FSE REPLACED THE LASER DIODE DRIVERS. SYSTEM PERFORMING TO SPECIFICATIONS. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    CUSTOMER REPORTED HORIZONTAL GAS BREAKS ON PATIENT'S LEFT FLAP. FLASHING BY THE FLAP POCKET. FLAT LIFTED OKAY. NO PATIENT INJURY, TREATMENT COMPLETED OKAY. POCKET SETTINGS WERE CHANGED, AND NO FURTHER CASES RESULTED WITH HORIZONTAL GAS BREAKTHROUGH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782649 INTRALASE FS2 POWERED LASER SURGICAL INSTRUMENT GEX AMO MANUFACTURING USA, LLC R20003D

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose Other