BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS ITEC PRELOADED 1-PIECE IOL

    MDR report key: 7509469 · Received May 12, 2018

    Report

    Report Number
    2648035-2018-00702
    Event Type
    Injury
    Date Received
    May 12, 2018
    Date of Event
    April 9, 2018
    Report Date
    May 11, 2018
    Manufacturer
    JOHNSON AND JOHNSON SURGICAL VISION, INC.
    Product Code
    HQL
    UDI-DI
    05050474558298
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF EXPLANTED; GIVE DATE: N/A (NOT APPLICABLE). THE INTRAOCULAR LENS REMAINS IMPLANTED. (B)(4). DEVICE EVALUATION: THE LENS REMAINS IMPLANTED. THE FIBER COULD NOT BE REMOVED. THE COMPLAINT REPORTED COULD NOT BE CONFIRMED. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE PRODUCT WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATIONS. A SEARCH REVEALED THAT NO ADDITIONAL COMPLAINTS FOR THIS ORDER NUMBER HAVE BEEN RECEIVED. LABELING REVIEW: THE DIRECTIONS FOR USE (DFU) WERE REVIEWED. THE DFU PROVIDE THE CUSTOMER WITH PROPER USAGE INSTRUCTIONS AND GUIDELINES. 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 · 1

    IT WAS REPORTED THAT DURING CATARACT SURGERY, WHILE AND AFTER IMPLANTING THE INTRAOCULAR LENS (IOL) IN THE PATIENT'S LEFT EYE, THE DOCTOR OBSERVED UNDER HER SURGICAL MICROSCOPE A FLOATING FIBER-LIKE PARTICLE IN THE ANTERIOR CHAMBER AS SHE WAS RUNNING THE IRRIGATION ASPIRATION (IA) CANNULA IN THE EYE TO ASPIRATE THE ALCON PROVISC OVD FROM THE EYE. AFTER A FEW SECONDS RUNNING THE IA, THE ¿¿SPINNING¿¿ FIBER COULD NOT BE SEEN ANYMORE. THE DOCTOR THEREFORE ASSUMED IT HAD BEEN ASPIRATED OUT OF THE EYE AS DESIRED THROUGH THE IA TUBING. ON POST OP DAY 1 VISIT ((B)(6)), THE PATIENT¿S VISION SEEMED NORMAL (6/6+) AND PATIENT WAS SATISFIED. THERE WAS NO INFLAMMATION. HOWEVER, AT SLIT LAMP OBSERVATION, THE DOCTOR IDENTIFIED THAT SAME CLEAR, LONG (ESTIMATED TO 3 MM), SOMEHOW CURLY FIBER STUCK IN THE ANGLE (NASAL TRABECULAR MESHWORK) OF HER PATIENT¿S LEFT (OS) EYE. AFTER CONSULTING WITH HER COLLEAGUE, A SECOND SURGERY WAS PLANNED AND PERFORMED THAT SAME NIGHT ((B)(6), 7 PM) TO ATTEMPT REMOVING THE PARTICLE FROM ITS POSITION. DURING THIS SECONDARY SURGERY, THE DOCTOR WENT IN THE ANTERIOR CHAMBER AT LEAST 3 TIMES WITH THE IA CANNULA AND ASPIRATED THOROUGHLY ALTHOUGH THE FIBER COULD NOT BE SEEN AT ANY TIME UNDER THE SURGICAL MICROSCOPE VIEW. THE FOLLOWING DAY (POST OP DAY 2, (B)(6)), THE DOCTOR SAW THE PATIENT AT HER CLINIC AND DISCOVERED, UNDER SLIT LAMP VIEW THAT THE FIBER WAS STILL IN THE ANGLE AND HAD NEVER MOVED FROM ITS INITIAL POSITION DESPITE THE SECONDARY SURGERY. THERE WAS NO ABNORMAL INFLAMMATION AND A NORMAL VISION (6/9 IMPROVABLE TO 6/7.5) WITH A GRADING OF THE ANTERIOR CHAMBER CELLS OF 1+ ACCORDING TO THE DOCTOR, CONSIDERING THE IMPACT OF THE SECONDARY SURGERY. AFTER CONSULTING HER COLLEAGUE AGAIN AND AFTER EXPLAINING THE SITUATION TO THE PATIENT, ALL 3 DECIDED TO NOT GO UNDER SURGERY AGAIN. THE DOCTOR WOULD COMMIT TO CLOSELY MONITOR THE SITUATION OVER THE NEXT WEEKS OR SO. THE PATIENT WAS SEEN BY THE DOCTOR AGAIN ON (B)(6). THERE WAS NO INFLAMMATION, SATISFYING VISION (6/7.5 +2) AND STABLE, ½+ ANTERIOR CHAMBER CELLS GRADING. THE SLIGHTLY WAVY CLEAR FIBER APPEARS TO STILL BE STUCK IN THE SAME POSITION. THE HEALING PROCESS SEEMS VERY GOOD AND PATIENT SHOWS NO SIGN OF INFLAMMATORY RESPONSE ACCORDING TO DR. CORBIN WHO WILL CONTINUE TO MONITOR THE PATIENT¿S SITUATION IN THE NEAR FUTURE. HOWEVER, NO MORE ATTEMPT TO REMOVE THE FIBER IS PLANNED AT THE TIME OF THIS REPORT. THERE WAS NO NEED FOR SUTURES, VITRECTOMY OR INCISION ENLARGEMENT. IT WAS NOTED THAT THE FIBER-LIKE PARTICLE IS NOT VISIBLE UNDER THE SURGICAL MICROSCOPE (AFTER THE SECONDARY SURGERY); IT CAN ONLY BE SEEN UNDER SLIT-LAMP VIEWING. VISUAL ACUITY POST-OPERATIVE: 6/6 AT POST OP DAY 1, 6/9 (6/7.5) MORNING AFTER SECONDARY SURGERY, 6/7.5++ AT POST OP DAY 4. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON AND JOHNSON SURGICAL VISION, INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352095 TECNIS ITEC PRELOADED 1-PIECE IOL MONOFOCAL IOLS HQL JOHNSON AND JOHNSON SURGICAL VISION, INC. PCB00 05050474558298

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention