Johnson & Johnson Vision Announces New Data, Products, and Physician Resources to Elevate Patient Care at AAO 2019
- U.S. FDA approves Wavefront-Guided PRK, giving the iDESIGN® Refractive Studio the most extensive Wavefront-Guided indications available in the U.S, including LASIK, PRK and monovision procedures
- TECNIS SimplicityTM Delivery System launches in the U.S. as a preloaded, fully disposable IOL delivery system for improved efficiency for practices and enhanced safety for cataract patients1
- Launch of new program for eye care practices, CHiME, with the unveiling of state-of-the-art inventory management system
Santa Ana, Calif. October 11, 2019 – Johnson & Johnson Vision, a global leader in eye health, is announcing a series of breakthrough data, technology, and products at the upcoming 2019 American Academy of Ophthalmology (AAO) Annual Meeting in San Francisco, CA. The company will be announcing the U.S. Food & Drug Administration (FDA) approval of the iDESIGN Refractive Studio Wavefront-guided PRK indication and the availability of TECNIS Simplicity Delivery System.
“Innovation comes in many forms - ranging from products and treatment techniques, to innovations that make practice management easier so that ophthalmologists can focus on the work that matters most – helping patients see better, connect better, live better,” said Tom Frinzi, Worldwide President, Surgical, Johnson & Johnson Vision. “As a global leader in eye health, we’re moving the needle on all these fronts. At AAO, we are announcing our new IOL insertion system TECNIS Simplicity, adding a PRK indication to our industry-leading iDESIGN Refractive Studio, and introducing CHiME Manage, a new innovation in inventory management.”
TECNIS Simplicity Delivery System
Johnson & Johnson Vision innovations go beyond improving patient outcomes to improving care delivery for surgeons as well. TECNIS Simplicity Delivery System, now FDA-approved, is a new preloaded, fully disposable intraocular lens delivery system that is designed to prevent loading errors, simplify lens delivery, and protect against contamination to help elevate the standard of care for patients when paired with a TECNIS 1-piece IOL.1
“The TECNIS Simplicity makes preloaded delivery simple and efficient for all the team members in the operating room. In my own experience, preloaded lens technology has improved my efficiency and care for patients during cataract surgery,” said Preeya Gupta, MD†, Corneal Specialist at Duke University Eye Center. The TECNIS 1-piece IOL is now available preloaded in the TECNIS Simplicity Delivery System in the United States.
New Data & FDA Approval for Wavefront-Guided PRK Indication for iDESIGN Refractive Studio
The FDA has approved the use of Wavefront-Guided PRK for the iDESIGN Refractive Studio, expanding options for surgeons across LASIK, PRK and monovision procedures. New clinical data being presented at AAO, raises the barǂ for the industry in visual acuity outcomes and patient satisfaction for the WFG-PRK procedure2:
- 99% of patients achieved 20/16 or better binocular uncorrected visual acuity (UCVA) at six-months postop
- 99% of subjects reported being very satisfied to completely satisfied with their vision 6-months postop
"The FDA approval makes the iDESIGN Refractive Studio the first and only system with a Wavefront-Guided PRK indication. This expands a patient’s options for truly personalized laser vision correction, and opens the door for wider adoption of this amazing technology," said Christopher Blanton, MD†, President of Inland Eye Institute in Colton, CA.
The new software will be commercially available in the first quarter of 2020.
New Offerings for Eye Care Professionals to Aid in Practice Management
Johnson & Johnson Vision is announcing CHiME, a new program committed to allowing ophthalmologic practices the freedom to focus on what matters most – patient care. CHiME tests and launches offerings for today’s busy practices with a goal of making their customer experience effortless.
Building on the unveiling of Customer Connect, a breakthrough e-commerce system launched earlier this year, Johnson & Johnson Vision is introducing CHiME Manage - an all-inclusive smart inventory management system that will automate the inventory process for its products, while also providing safeguards in patient care. CHiME Manage will help practices plan and optimize inventory utilization, streamline ordering, provide valuable insight with actionable reporting, reduce human picking errors, and assist in expiration management. The cabinet will be revealed at AAO and piloted in several practices across the U.S. this fall.
Johnson & Johnson Vision
At Johnson & Johnson Vision, part of Johnson & Johnson Medical Devices Companies,* we have a bold ambition: to change the trajectory of eye health around the world. Through our operating companies, we deliver innovation that enables eye care professionals to create better outcomes for patients throughout their lives, with products and technologies that address unmet needs including refractive error, cataracts and dry eye. In communities with greatest need, we work in collaboration to expand access to quality eye care, and we are committed to helping people see better, connect better and live better. Visit us at www.jjvision.com. Follow @JNJVision on Twitter and Johnson & Johnson Vision on LinkedIn.
About Johnson & Johnson Medical Devices Companies*
At Johnson & Johnson Medical Devices Companies, we are helping people live their best lives. Building on more than a century of expertise, we tackle pressing healthcare challenges, and take bold steps that lead to new standards of care while improving people’s healthcare experiences. In surgery, orthopaedics, vision and interventional solutions, we are helping to save lives and paving the way to a healthier future for everyone, everywhere.
* The Johnson & Johnson Medical Devices Companies comprise the surgery, orthopaedics, vision and interventional solutions businesses within Johnson & Johnson’s Medical Devices segment.
† Drs. Preeya Gupta and Chris Blanton are paid consultants to Johnson & Johnson Surgical Vision.
ǂ Based on FDA manufacturer excimer platform results, head to head studies, non-comparative studies, and podium abstracts & posters, iDESIGN has been shown to deliver 20/16 or better visual outcomes in majority of myopia patients. Data available upon request.
1 TECNIS ® 1 IOL with TECNIS ® Simplicity TM Delivery System [DFU, package insert]. Santa Ana,
Calif. Johnson & Johnson Surgical Vision. 2019.
2 PMA P930016/S057: FDA Summary of Safety and Effectiveness Data
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All trademarks are the intellectual property of Johnson & Johnson Surgical Vision, Inc.
© Johnson & Johnson Surgical Vision, Inc. 2019
Important Safety Information
INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR TECNIS® MONOFOCAL 1-PIECE IOL
Rx Only
INDICATIONS
TECNIS® 1-Piece Lenses are indicated for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. These devices are intended to be placed in the capsular bag.
PRECAUTIONS
Do not resterilize the lens. Most sterilizers are not equipped to sterilize the soft acrylic material without producing undesirable side effects. Do not soak or rinse the intraocular lens with any solution other than sterile balanced salt solution or sterile normal saline. Do not store the lens in direct sunlight or at a temperature greater than 113°F (45°C). Do not autoclave the intraocular lens. Please refer to the specific instructions for use provided with the insertion instrument or system for the amount of time the IOL can remain folded before the IOL must be discarded. When the insertion system is used improperly, the haptics of the TECNIS® 1-Piece Lens may become damaged.
WARNINGS
Physicians considering lens implantation should weigh the potential risk/benefit ratio for any conditions described in the TECNIS®
1-Piece IOL Directions for Use that could increase complications or impact patient outcomes. These conditions include recurrent severe anterior or posterior segment inflammation or uveitis; patients in whom the intraocular lens may affect the ability to observe, diagnose, or treat posterior segment diseases; surgical difficulties at the time of cataract extraction, which may increase the potential for complications (e.g., persistent bleeding, significant iris damage, uncontrolled positive pressure or significant vitreous prolapse or loss); a compromised eye due to previous trauma or developmental defects in which appropriate support of the IOL is not possible; circumstances that would result in damage to the endothelium during implantation; suspected microbial infection; or patients in whom neither the posterior capsule nor the zonules are intact enough to provide support for the IOL. Children under the age of 2 years are not suitable candidates for intraocular lenses. The TECNIS® 1-Piece IOL should not be placed in the ciliary sulcus.
ADVERSE EVENTS
In 3.3% of patients, reported adverse events of cataract surgery with the 1-Piece IOL included macular edema. Other reported reactions occurring in less than 1% of patients were secondary surgical intervention (pars plana vitrectomy with membrane peel) and lens exchange (due to torn lens haptic).
INDICATIONS AND IMPORTANT SAFETY INFORMATION for the TECNIS ® 1-Piece IOL with the
TECNIS SIMPLICITY™ Delivery System
Rx Only
ATTENTION
Reference the Directions for Use labeling for a complete listing of indications and important safety
information.
INDICATIONS
The TECNIS SimplicityTM Delivery System is used to fold and assist in inserting the TECNIS ® 1-Piece intraocular lens for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. These devices are intended to be placed in the capsular bag.
PRECAUTIONS
This is a single use device, do not re-sterilize the lens or the TECNIS Simplicity™ Delivery System. Most sterilizers are not equipped to sterilize the soft acrylic material and the preloaded inserter material without producing undesirable side effects. Do not store the device in direct sunlight or at a temperature under 5°C (41°F) or over 35°C (95°F). Do not autoclave the TECNIS Simplicity™ Delivery System. Do not advance the lens unless ready for lens implantation. The contents are sterile unless the package is opened or damaged. The recommended temperature for implanting the lens is at least 17°C (63°F). The use of balanced salt solution (BSS) or viscoelastics is required when using the TECNIS Simplicity™ Delivery System. For optimal performance when using OVD, use the HEALON ® family of viscoelastics. The use of BSS with additives has not been studied for this product. Do not use if the TECNIS Simplicity™ Delivery System has been dropped or if any part was inadvertently struck while outside the
shipping box. The sterility of the TECNIS Simplicity™ Delivery System and/or the lens may have been compromised. When the insertion system is used improperly, the haptics of the TECNIS ® 1-piece lens may become damaged.
WARNINGS
Physicians considering lens implantation under any of the following circumstances should weigh the potential risk/benefit ratio: a. Patients with recurrent severe anterior or posterior segment inflammation or uveitis. b. Patients in whom the intraocular lens may affect the ability to observe, diagnose or treat posterior segment diseases. c. Surgical difficulties at the time of cataract extraction, which may increase the potential for complications (e.g., persistent bleeding, significant iris damage, uncontrolled positive pressure or significant vitreous prolapse or loss). d. A compromised eye due to previous trauma or developmental defect in which appropriate support of the IOL is not possible. e. Circumstances that would result in damage to the endothelium during implantation. f. Suspected microbial infection. g. Patients in whom neither the posterior capsule nor the zonules are intact enough to provide support for the IOL. Children under the age of 2 years are not suitable candidates for intraocular lenses. Do not attempt to disassemble, modify or alter the TECNIS Simplicity™ Delivery System or any of its components, as this can significantly affect the function and/or structural integrity of the design. Do not use if the cartridge of the TECNIS Simplicity™ Delivery System is cracked or split prior to implantation. Do not implant the lens if the rod tip does not advance the lens or if it is jammed in the TECNIS Simplicity™ Delivery System. During initial lens advancement, quick advancement of the plunger is needed. Do not stop or reverse
while advancing the plunger. Doing so may result in improper folding of the lens. After initial lens advancement and the half turn rotation step, do not move the plunger forward until ready for lens implantation. Doing so may result in the lens being stuck in the cartridge. The lens and TECNIS Simplicity™ Delivery System should be discarded if the lens has been folded within the cartridge for more than 10 minutes. Not doing so may result in the lens being stuck in the cartridge. Johnson & Johnson Surgical Vision, Inc. single-use medical devices are labeled with instructions for use and handling to minimize exposure to conditions which may compromise the product, patient, or the user. When used according to the directions for use, the TECNIS Simplicity™ Delivery System minimizes the risk of infection and/ or inflammation associated with contamination. The reuse / re-sterilization / reprocessing of Johnson & Johnson Surgical Vision, Inc. single-use devices may result in physical damage to the medical device, failure of the medical device to perform as intended, and patient illness or injury due to infection, inflammation, and/or illness due to product contamination, transmission of infection, and lack of product sterility. The TECNIS ® 1-Piece IOL should be placed entirely in the capsular bag. Do not place the lens in the ciliary sulcus. Use of methyl cellulose viscoelastics is not recommended as they have not been validated with the TECNIS Simplicity™ Delivery System.
ADVERSE EVENTS
The most frequently reported adverse event that occurred during the clinical trial of the 1-Piece IOL was cystoid macular edema, which occurred at a rate of 3.3%. Other reported events occurring in less than 1% of patients were secondary surgical intervention (0.8%, vitrectomy) and lens exchange (0.8%, due to torn lens haptic).
STAR S4 IR® Excimer Laser System and the iDESIGN® Refractive Studio
INDICATIONS AND IMPORTANT SAFETY INFORMATION for the STAR S4 IR® Excimer Laser System and the
iDESIGN® Refractive Studio for Wavefront-Guided Photorefractive Keratectomy (PRK)
INDICATIONS: The STAR S4 IR® Excimer Laser System and the iDESIGN® Refractive Studio is indicated for wavefront-guided photorefractivekeratectomy (PRK) in patients: with myopia, with or without astigmatism, as measured by iDESIGN ® Refractive
Studio System with spherical equivalent up to -8.00 D, and cylinder up to -3.00 D, with agreement between
manifest refraction (adjusted for optical infinity) and iDESIGN ® Refractive Studio System refraction as follows:
Spherical Equivalent: Magnitude of the difference is less than 0.625 D, Cylinder: Magnitude of the difference is less
than or equal to 0.5 D, in patients 18 years of age or older; with refractive stability (a change of ≤1.0 D in manifest
refraction spherical equivalent for a minimum of 12 months prior to surgery), and with wavefront capture
diameter of at least 4 mm.
CONTRAINDICATIONS: iDESIGN ® System driven PRK surgery is contraindicated in patients with any type of active
connective tissue disease or autoimmune disease, in patients with signs of keratoconus, abnormal corneal
topography, and degenerations of the structure of the cornea, in patients whose corneal thickness would cause
anticipated treatment would violate the posterior 250 microns (μm) of corneal stroma, in patients with
uncontrolled diabetes, in patients with active eye infection or active inflammation, in patients with recent herpes
eye infection or problems resulting from past infection, in patients with significant dry eyes. If the patients have
severely dry eyes, PRK may increase the dryness. This may or may not go away. Severe eye dryness may delay
healing or interfere with the surface of the eye after surgery. It may result in poor vision after PRK.
WARNINGS AND PRECAUTIONS: iDESIGN ® System driven PRK surgery is not recommended in patients have
systemic diseases that may affect wound healing, such as controlled autoimmune, or connective tissue disease, or
controlled diabetes, have an immunocompromised status or take medications that may result in a weakened
immune system such as antimetabolites for any medical conditions or affect wound healing such as Isotretinoin
(Accutane), have a history of Herpes simplex or Herpes zoster keratitis, have glaucoma, In patients with a cardiac
pacemaker, implanted defibrillator or another implanted electronic device, have mild to moderate dry eye, have
decreased vision in one eye (e.g., amblyopia). Surgeons are reminded that they should instruct the patient to fixate
on the Patient Fixation LED during surgery with or without the use of the ActiveTrak System. Please refer to
Operator’s Manual for a list of additional Precautions.
CAUTION: U.S. Federal law restricts this device to sale, distribution, and use by or on the order of a physician or
other licensed eye care practitioner who has been trained in the calibration and operation of this device.
ADVERSE EVENTS: Please refer to Operator’s Manual for a list of Adverse Events and Complications in clinical
studies for wavefront-guided PRK Patients Myopia and Myopic Astigmatism.
For further information, contact:
Allie Holmes
Johnson & Johnson Vision
949-244-7012 (mobile)
Jamie Hall
Pascale Communications, LLC
724-417-0167 (mobile)
jamie@pascalecommunications.com
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