BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 20272950 · Received September 20, 2024

    Report

    Report Number
    3012236936-2024-000248
    Event Type
    Injury
    Date Received
    September 20, 2024
    Date of Event
    August 21, 2024
    Report Date
    September 20, 2024
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    GEX
    PMA / PMN Number
    K063682
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A2, A4 AND A5: PER REGULATION EU 2016/679 (GENERAL DATA PROTECTION REGULATION), PATIENT IDENTIFIERS WERE NOT COLLECTED OR RECORDED AND THEREFORE ARE NOT AVAILABLE. SECTION D6A - IMPLANT DATE: NOT APPLICABLE. THE INTRALASE FS2 IS NOT AN IMPLANTABLE DEVICE. SECTION D6B - EXPLANT DATE: NOT APPLICABLE. THE INTRALASE FS2 IS NOT AN IMPLANTABLE DEVICE; THEREFORE, NOT EXPLANTED. SECTION E1 - TELEPHONE NUMBER: (B)(6). DEVICE EVALUATION: THE FIELD SERVICE ENGINEER (FSE) WENT ON SITE TO EVALUATE THE SYSTEM. A GEL CHECK WAS PERFORMED. THE SYSTEM IS PERFORMING TO SPECIFICATION. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE DEVICE WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. CONCLUSION: AS A RESULT OF THE INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE FLAP WAS NOT CUT CORRECTLY DURING LASIK SURGERY AND THAT THE FLAP COULD NOT BE FOLDED DOWN. THROUGH FOLLOW UPS WE LEARNED THAT AFTER THE OPERATION WAS STOPPED, THE PATIENT WAS FITTED WITH A BANDAGE LENS. A CORNEAL OPTICAL COHERENCE TOMOGRAPHY (OCT) WAS PERFORMED THE FOLLOWING DAY. NO FURTHER MEASURES HAVE BEEN TAKEN TO DATE. NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1801904 INTRALASE FS2 POWERED LASER SURGICAL INSTRUMENT GEX AMO MANUFACTURING USA, LLC 20003K

    Patients

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