BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IFS ADVANCED FEMTOSEC LASER

    MDR report key: 19885724 · Received August 1, 2024

    Report

    Report Number
    3012236936-2024-000211
    Event Type
    Injury
    Date Received
    August 1, 2024
    Date of Event
    May 23, 2024
    Report Date
    December 5, 2024
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    GEX
    PMA / PMN Number
    K141852
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G3: DURING A REVIEW OF THE RECORDS RELATED TO THIS EVENT IT WAS FOUND THAT THE DATE PROVIDED IN THE INITIAL MDR SECTION G3 SHOULD HAVE BEEN POPULATED WITH THE DATE (B)(6) 2024. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: INVESTIGATION WAS UPDATED. THE FOLLOWING CODES ARE NOW ADDED: COMPONENT CODE: 4756 FOR APPROPRIATE TERM/CODE NOT AVAILABLE COMPONENT CODE: 865 FOR LASER RESULT CODE: 659 FOR POWER FLUCTUATION.

    Additional Manufacturer Narrative · 0

    CORRECTION: IN THE INITIAL REPORT IT WAS FORGOTTEN TO MENTION THAT FIELD SERVICE WAS DISPATCHED TO PERFORM SYSTEM EVALUATION FOR TRANSIENT LIGHT SENSITIVITY SYNDROME (TLSS) AND REPLACED PRE EXPANDER, PERFORMED AUTO CORRELATION, SPOT SIZE CAMERA, ALIGNMENTS, GEL EVALUATION AND PERFORM PREVENTATIVE MAINTENANCE. SYSTEM PERFORMING TO SPECIFICATION. ADDITIONAL INFORMATION: 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 & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION A3 AND A4: UNKNOWN/ NOT PROVIDED DEVICE EVALUATION: ON (B)(6) 2024, JNJ CLINICAL APPLICATION SPECIALIST VISITED SITE AND GELLED LASER AT AT 5/5 @ 0.65 WITH 80% MELT, 6/6 @ 0.85 AT 80% MELT AND 7/7 @ 1.05 AT 80% MELT. DOCTOR'S SETTINGS ARE 7/7 WITH BED ENERGY AT 1.0 AND SIDE CUT ENERGY AT 0.90. HIS FLAP THICKNESS IS SET AT 100UM. MAX ENERGY AT STARTUP WAS 2.19UJ. AFTER GELLING, CLINICAL DID AN ENERGY WHEEL INITIALIZATION AND IT WAS 2.26UJ. ROOM TEMPERATURE WAS FOUND AT 65 DEGREE F, HUMIDITY 33%. ON (B)(6) 2024, CLINICAL RETURNED TO SITE AND OBSERVED 13 LASIK CASES PERFORMED BY THE DOCTOR. INTRALASE PERFORMED WELL. INITIAL MAX ENERGY 2.19 AND SUBSEQUENTLY STAYED AT 2.26 THE REST OF THE DAY. TEMP/HUMIDITY STAYED CONSTANT AT 65F/33%. SETTINGS USED WERE 1.00 BED ENERGY, 0.90 SIDE-CUT ENERGY, FLAP THICKNESS 100UM. EASY LIFTS AND DOCTOR WAS HAPPY WITH ITS' PERFORMANCE. MANUFACTURING RECORDS REVIEW: A MANUFACTURER RECORD REVIEW RELATED TO THE DEVICE INCLUDING DEVICE HISTORY RECORD WILL BE PERFORMED. UPON COMPLETION OF THIS REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED THAT CHANGES THE FACTS AND/OR CONCLUSION, A SUPPLEMENTAL MEDWATCH WILL BE FILED. 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

    IT WAS REPORTED THAT PATIENT HAD SURGERY ON (B)(6) 2024 AND HAD A MILD VERTICAL GAS BREAKTHROUGH (VGB). TECHNICIAN BELIEVES THE AFFECTED EYE WAS THE LEFT (OS). THE PROCEDURE WAS COMPLETED. PRE-SURGERY BEST CORRECTED VISUAL ACUITY (BCVA) 20/20. PRESENT STATUS POST SURGERY 20/25+2 RIGHT EYE (OD) - 20/20+ OS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1978413 IFS ADVANCED FEMTOSEC LASER POWERED LASER SURGICAL INSTRUMENT GEX AMO MANUFACTURING USA, LLC J20007D

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Unknown Other