BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 24040017 · Received January 12, 2026

    Report

    Report Number
    3012236936-2026-000009
    Event Type
    Injury
    Date Received
    January 12, 2026
    Date of Event
    December 19, 2025
    Report Date
    March 5, 2026
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    GEX
    UDI-DI
    05050474540231
    PMA / PMN Number
    K063682
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A2, A4 AND A5: PER REGULATION EU (B)(4) (GENERAL DATA PROTECTION REGULATION), PATIENT IDENTIFIERS WERE NOT COLLECTED OR RECORDED AND THEREFORE ARE NOT AVAILABLE. SECTION D6A - IMPLANT DATE: NOT APPLICABLE. FS LASER IS NOT AN IMPLANTABLE DEVICE. SECTION D6B - EXPLANT DATE: NOT APPLICABLE. FS LASER IS NOT AN IMPLANTABLE DEVICE; THEREFORE, NOT EXPLANTED. SECTION E1 - TELEPHONE NUMBER: (B)(6). SECTION H3 - THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF RECORDS INCLUDING DEVICE HISTORY AND COMPLAINT TRENDING WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION H3 - DEVICE EVALUATED BY MANUFACTURER? YES. DEVICE EVALUATION: SERVICE ONSITE TO EVALUATE THE SYSTEM. SERVICE VERIFIED PARAMETERS WITH THE CUSTOMER THAT POCKET WAS OFF, THIS WAS REASON FOR ALL THE ISSUES. SERVICE VERIFIED THE MELTING, SIDE CUT RETRACES, HORIZONTAL OVERLAP, APPLANATION PRESSURE, ENERGY, AND Z CALIBRATION WAS COMPLETED. THE SYSTEM IS IN SPECIFICATION. THE SYSTEM IS PERFORMING TO SPECIFICATION. DEVICE HISTORY RECORD SHOWS THAT THE SYSTEM AND ITS COMPONENTS MET ALL SPECIFICATIONS PRIOR TO BEING RELEASED. CONCLUSION: BASED ON THE COMPLAINT INVESTIGATION RESULTS, THE PRODUCT WAS RELEASED WITHIN SPECIFICATIONS. NO PRODUCT DEFICIENCY OR PRODUCT MALFUNCTION. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SIDE CUT ISSUES, FLAPS ISSUES AND OPAQUE BUBBLE LAYER (OBL) OCCURRED. THEY COULD NOT SEE THE POCKET. THREE PATIENTS NEEDED CONTACT LENS PROTECTION AFTER SURGERIES DUE TO A DAMAGED EPITHELIUM. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE OF THE THREE PATIENTS. SEPARATE REPORTS WILL BE SUBMITTED FOR THE OTHER PATIENTS. THE REPORTED ISSUES COULD NOT BE SPECIFICALLY LINKED TO ANY SPECIFIC PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56934 INTRALASE FS2 POWERED LASER SURGICAL INSTRUMENT GEX AMO MANUFACTURING USA, LLC 20005K 05050474540231

    Patients

    Seq Age Sex Outcome Treatment
    1