BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 19120205 · Received April 16, 2024

    Report

    Report Number
    3012236936-2024-01079
    Event Type
    Injury
    Date Received
    April 16, 2024
    Date of Event
    March 27, 2024
    Report Date
    May 2, 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
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: H4: IN INITIAL REPORT, THE MANUFACTURER DATE PROVIDED WAS INADVERTENTLY REPORTED AS 12/23/2007, HOWEVER THE CORRECT DATE IS 05/31/2005. ADDITIONAL INFORMATION: SECTION B5 - DESCRIBE EVENT OR PROBLEM: THROUGH FOLLOW-UP, WE LEARNED, THAT ISSUES A PERIPHERAL VERTICAL GAS BREAKTHROUGH (VGB) AND OPAQUE BUBBLE LAYER (OBL) OCCURRED. THE PATIENT FULLY RECOVERED WITHOUT ANY TREATMENT. NO FURTHER DETAILS WERE PROVIDED. SECTION H6 -HEALTH EFFECT - CLINICAL CODE: 4581: HS-OPAQUE BUBBLE LAYER. DEVICE EVALUATION: THE FIELD SERVICE ENGINEER (FSE) WENT ON SITE TO EVALUATE THE SYSTEM. PARTS WERE EXCHANGED AND THE SYSTEM WAS ALIGNED AND CALIBRATED. THE SYSTEM MET ALL SPECIFICATIONS AND IS READY FOR USE. 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..

    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: IF IMPLANTED, GIVE DATE: NOT APPLICABLE, AS SYSTEM IS NOT AN IMPLANTABLE DEVICE. SECTION D6B: IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS SYSTEM IS NOT AN IMPLANTABLE DEVICE. SECTION E1 - EMAIL ADDRESS: UNKNOWN, AS INFORMATION WAS REQUESTED BUT NOT PROVIDED. (B)(6). SECTION H3 - OTHER (81): THE DEVICE WAS NOT RETURNED FOR EVALUATION. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD, COMPLAINT TRENDING, AND RISK DOCUMENTATION FOR THIS DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW AND POSSIBLE PRODUCT RETURN AND EVALUATION, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. ATTEMPTS HAVE BEEN MADE TO OBTAIN MISSING INFORMATION. HOWEVER, TO DATE, NO RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BLACKSPOT/ BUTTONHOLE OCCURRED IN THE PATIENT FLAP FOR 3 PATIENTS. NO FURTHER DETAILS PROVIDED. THIS ISSUE OCCURRED THREE TIMES ON THE SAME DAY WITH THREE DIFFERENT PATIENTS. TWO SEPARATE REPORTS ARE BEING SUBMITTED FOR THE OTHER PATIENTS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1063226 INTRALASE FS2 POWERED LASER SURGICAL INSTRUMENT GEX AMO MANUFACTURING USA, LLC 20003K

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other