BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IFS ADVANCED FEMTOSEC LASER

    MDR report key: 11827080 · Received May 14, 2021

    Report

    Report Number
    3006695864-2021-07693
    Event Type
    Injury
    Date Received
    May 14, 2021
    Report Date
    May 14, 2021
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    GEX
    PMA / PMN Number
    K141852
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE PRODUCT TESTING WAS NOT PERFORMED. THE REPORTED COMPLAINT CANNOT BE CONFIRMED. 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 AND THE REPORTED ISSUE COULD NOT BE VERIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    LITERATURE TITLE: FEMTOSECOND LASERASSISTED DEEP ANTERIOR LAMELLAR KERATOPLASTY FOR KERATOCONUS: MULTISURGEON RESULTS KUNAL A. GADHVI, VITO ROMANO, LUIS FERNA¿ NDEZ-VEGA CUETO, FRANCESCO AIELLO, ALEXANDER C. DAY, DANIEL M. GORE, AND BRUCE D. ALLAN. A SINGLE-CENTER, COMPARATIVE, RETROSPECTIVE INTERVENTIONAL CASE WAS DONE TO COMPARE THE CLINICAL OUTCOMES IN FEMTOSECOND LASERASSISTED DEEP ANTERIOR LAMELLAR KERATOPLASTY (F-DALK) TO MANUAL NON-LASER DEEP ANTERIOR LAMELLAR KERATOPLASTY (M-DALK) FOR KERATOCONUS IN A MULTISURGEON PUBLIC HEALTHCARE SETTING. FIFTY-EIGHT EYES OF 55 PATIENTS UNDERWENT F-DALK. MUSHROOM CUT PATTERN WAS PROGRAMMED IN BOTH DONOR AND HOST CORNEAS USING THE INTRALASE ENABLED KERATOPLASTY (IEK) TAB OF TREATMENT PLANNING SOFTWARE ON AN INTRALASE IFS FEMTOSECOND LASER (J&J VISION) USING DEFAULT ENERGY AND SPOT SEPARATION SETTINGS THROUGHOUT. INTRAOPERATIVE COMPLICATIONS IN THE F-DALK GROUP: 15 OUT OF 58 EYES HAD INTRAOPERATIVE PERFORATIONS; 2 OF WHICH REQUIRED CONVERSION TO PENETRATING KERATOPLASTY. POST-OPERATIVE COMPLICATIONS IN THE F-DALK GROUP: 2 EYES DEVELOPED DOUBLE ANTERIOR CHAMBER; THESE WERE TREATED WITH POSTOPERATIVE ANTERIOR CHAMBER AIR INJECTION. 1 EYE HAD PERSISTENT DOUBLE AC AFTER AIR INJECTION BECAUSE DESCEMET MEMBRANE WAS NOT REMOVED IN THE DONOR CORNEA INTRAOPERATIVELY; REVISION SURGERY WAS DONE TO REMOVE THE PERSISTENT DM. A COPY OF THE ARTICLE HAS BEEN ATTACHED TO THIS FOLDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724284 IFS ADVANCED FEMTOSEC LASER FEMTOSECOND LASER GEX AMO MANUFACTURING USA, LLC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention