Healthcare Industry News: U.S. Food and Drug Administration
News Release - November 9, 2017
Johnson & Johnson Vision Announces Series of Product Milestones and Launches Across Portfolio at American Academy of Ophthalmology 2017 MeetingMore than 350,000 TECNIS Symfony® and Symfony® Toric lenses, the first-ever extended depth of focus presbyopia correcting lenses, now in use by cataract patients worldwide
CATALYS® System Mobile Patient Bed now available, designed to ensure patient comfort and optimize physician workflow from start-to-finish during cataract procedures
TearScience LipiScan® and LipiFlow® now available in more than 800 eye care practices to image meibomian glands and treat meibomian gland dysfunction
iDESIGN® System achieves FDA approval for expanded indications in the U.S. with the most recent approval of hyperopia, with and without astigmatism
SANTA ANA, Calif., Nov. 9, 2017 -- (Healthcare Sales & Marketing Network) -- Johnson & Johnson Vision announced today a series of product milestones and launches supporting its growing portfolio, designed to improve and restore sight for patients worldwide. These will be showcased during the American Academy of Ophthalmology (AAO) 2017 Meeting in New Orleans, November 11-14.
"The milestones and launches announced during AAO 2017 serve to underscore Johnson & Johnson Vision's progress toward our aspiration to become a world leader in eye health," said Tom Frinzi, Worldwide President, Surgical Vision, Johnson & Johnson Vision. "We are proud to provide eye care professionals with the tools and innovations to help millions of patients every year achieve their best possible vision and eye health."
More than 350,000 TECNIS Symfony® and Symfony® Toric Lenses Implanted
As the first-ever extended depth of focus presbyopia correcting intraocular lenses (IOLs), TECNIS Symfony® lenses are able to mitigate the effects of presbyopia while delivering high-contrast vision. By age 80, more than half of all Americans either have a cataract or have had cataract surgery.1
CATALYS® System Mobile Patient Bed Now Available
The new mobile bed ensures patients are comfortable from start-to-finish during cataract procedures, allowing them to relax in one, ergonomically-designed and adjustable bed, without needing to change positions or beds. Workflow is also optimized for physicians as the bed integrates simply and seamlessly with the CATALYS® System through Bluetooth connectivity.
TearScience LipiScan® and LipiFlow® Now Available in Over 800 Offices
Now part of Johnson & Johnson Vision, TearScience LipiScan® and LipiFlow® technologies are now available in more than 800 optometrist and ophthalmologist offices in the U.S. and Canada. The news precedes the roll-out of a reduced pricing structure to enable more eye care professionals to access the latest technologies to rapidly image meibomian glands and treat meibomian gland dysfunction (MGD), a leading cause of dry eye. Dry eye affects more than 340 million people around the world2 and MGD is a leading cause of dry eye3—found in 86% of dry eye patients.4
iDESIGN® System Now Approved by FDA for Expanded Indications
The iDESIGN® System is now approved by the U.S. Food and Drug Administration for the following indications: myopia with and without astigmatism, hyperopia with and without astigmatism, and mixed astigmatism. The Company has also launched a new campaign, "When You Measure Better, You Treat Better," to underscore the importance of a wavefront-guided treatment approach to support excellent patient results. A three-second scan with the iDESIGN® System gathers over 1,200 micro readings, including information on the patient's wavefront aberrometry, wavefront refraction, corneal topography, keratometry, and pupillometry. This data is then used to create a personalized LASIK treatment, which achieves 20/16 or better vision for the majority of myopic eyes.
Educational Opportunities of Note During AAO
Johnson & Johnson Vision is proud to demonstrate its commitment to equipping eye care professionals with the tools, knowledge and skills to deliver the best outcomes for patients.
The Company is proud to announce a three-year grant to the International Society of Refractive Surgery (ISRS), a partner of the AAO, to sponsor a new externship program. Though this initiative, surgeons can learn and work side-by-side with leading experts throughout Africa, Europe and the Middle East. More information is available at: https://isrs.aao.org/externships.
A number of educational activities will also be available at the Company's booth (#125) and throughout the meeting. On-site attendees can participate in demonstrations featuring the new CATALYS® System Mobile Patient Bed, iDesign® System, WHITESTAR SIGNATURE® Pro Phacoemulsification System, and Tear Science's LipiScan® and LipiFlow® technologies.
"Assessing Vision Beyond Snellen Acuity: What Cataract Surgeons Need to Know About Optical Quality" David Chang, MD, Tuesday, November 14, 9:00-10:00 AM, Room 397, Floor 3 This instructional course will provide a practical, non-mathematical understanding of how optical principles apply to patient care. At the conclusion, attendees will be able to describe the impact of optics on visual quality and the methods used to assess these indices in the clinical setting, as they relate to the TECNIS® Family of IOLs.
"Advancements in Wavefront-Guided Technologies" Saturday and Sunday, November 11-12, 1:00 PM and 2:00 PM, Booth #125 These two presentations will provide information on taking LASIK procedures to the next level.
"Phaco, Laser, and Ocular Surface Management Demonstrations" Saturday and Sunday, November 11-12, 10:00 AM-4:00 PM, Booth #125 A variety of expert-led demonstrations will provide a chance for up-close learning.
Saturday and Sunday, November 11-12, 10:00 AM-4:00 PM, Booth #125 Individual sessions will be available with experts on surgical practice and procedures to ask questions and gain insights on the latest techniques and technologies. Reserve your timeslot at: boothprograms.jnjvisionsurgicaleducation.com.
Johnson & Johnson Vision
Johnson & Johnson Vision, through its operating companies, is committed to improving and restoring sight for patients worldwide. Since debuting the world's first disposable soft contact lens in 1987, Johnson & Johnson Vision Care, Inc. has been helping patients see better through their world-leading ACUVUE® Brand Contact Lenses portfolio. In 2017, with the addition of Abbott Medical Optics, Inc., the Johnson & Johnson Surgical Vision business, Johnson & Johnson invested further in eye health by expanding into cataract surgery, laser refractive surgery (LASIK) and consumer eye health. Serving more than 60 million patients a day across 103 countries, Johnson & Johnson Vision is committed to helping more people in more places improve or restore their sight. Dual headquartered in Jacksonville, Florida, and Santa Ana, California, Johnson & Johnson Vision has more than 10,000 employees worldwide.
INDICATIONS and IMPORTANT SAFETY INFORMATION for TECNIS SYMFONY and TECNIS SYMFONY TORIC IOLs
INDICATIONS FOR USE
The TECNIS Symfony Extended Range of Vision IOL, Model ZXR00, is indicated for primary implantation for the visual correction of aphakia, in adult patients with less than 1 diopter of pre-existing corneal astigmatism, in whom a cataractous lens has been removed. The lens mitigates the effects of presbyopia by providing an extended depth of focus. Compared to an aspheric monofocal IOL, the lens provides improved intermediate and near visual acuity, while maintaining comparable distance visual acuity. The Model ZXR00 IOL is intended for capsular bag placement only.
The TECNIS Symfony Toric Extended Range of Vision IOLs, Models ZXT150, ZXT225, ZXT300, and ZXT375, are indicated for primary implantation for the visual correction of aphakia and for reduction of residual refractive astigmatism in adult patients with greater than or equal to 1 diopter of preoperative corneal astigmatism, in whom a cataractous lens has been removed. The lens mitigates the effects of presbyopia by providing an extended depth of focus. Compared to an aspheric monofocal IOL, the lens provides improved intermediate and near visual acuity, while maintaining comparable distance visual acuity. The Model Series ZXT IOLs are intended for capsular bag placement only.
May cause a reduction in contrast sensitivity under certain conditions, compared to an aspheric monofocal IOL. Inform patients to exercise special caution when driving at night or in poor visibility conditions. Some visual effects may be expected due to the lens design, including: perception of halos, glare, or starbursts around lights under nighttime conditions. These will be bothersome or very bothersome in some people, particularly in low-illumination conditions, and on rare occasions, may be significant enough that the patient may request removal of the IOL.
Rotation of the Tecnis Symfony Toric IOLs away from their intended axis can reduce their astigmatic correction, and misalignment ?30° may increase postoperative refractive cylinder. If necessary, lens repositioning should occur as early as possible prior to lens encapsulation.
Reference the Directions for Use for a complete listing of Indications and Important Safety Information.
iDESIGN® Advanced WaveScan Studio System and STAR S4 IR® Excimer Laser System
Healthcare Professional Indications and Important Safety Information
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. ATTENTION: Reference the Operator's Manuals for the STAR S4 IR® Excimer Laser System and iDESIGN® Advanced WaveScan Studio (iDESIGN®) System for a complete listing of Indications and Important Safety Information. INDICATIONS: The STAR S4 IR® Excimer Laser and the iDESIGN® System is indicated for wavefront-guided LASIK in patients with myopia as measured by the iDESIGN® System up to -11.00 D SE, with up to -5.00 D cylinder; in patients with hyperopia with or without astigmatism as measured by the iDESIGN® System up to +4.00 D SE, with up to +2.00 D cylinder; and in patients with mixed astigmatism as measured by the iDESIGN® System where the magnitude of the cylinder (1.0 D to 5.0 D) is greater than the magnitude of the sphere, and the cylinder and sphere have opposite signs; with agreement between manifest refraction (adjusted for optical infinity) and the iDESIGN® System refraction of 1) SE: magnitude of the difference is ? 0.625 D, and 2) cylinder: magnitude of the difference is = 0.5 D; with patients 18 years of age and older, and with refractive stability (a change of = 1.0 D in sphere or cylinder for a minimum of 12 months prior to surgery). CONTRAINDICATIONS: Laser refractive surgery is contraindicated for: patients with collagen vascular, autoimmune, or immunodeficiency diseases, pregnant or nursing women, patients with signs of corneal abnormalities including signs of keratoconus, abnormal corneal topography, epithelial basement membrane disease (EBMD) and degenerations of the structure of the cornea, patients with symptoms of significant dry eyes, patients whose corneal thickness would cause the anticipated treatment to violate the posterior 250 microns (µm) of corneal stroma, and in patients with advanced glaucoma, and uncontrolled diabetes. If the patients have severely dry eyes, LASIK may increase the dryness; this may or may not go away. Severe eye dryness may delay healing of the flap or interfere with the surface of the eye after surgery; it may result in poor vision after LASIK. WARNINGS AND PRECAUTIONS: LASIK is not recommended in patients who: have systemic diseases likely to affect wound healing, such as autoimmune connective tissue disease, diabetes or an immunocompromised status, have a history of Herpes simplex or Herpes zoster keratitis, have severe allergies or tendency rub their eyes often, have glaucoma, elevated IOP, ocular hypertension or being followed for possible glaucoma (glaucoma suspect), are taking the medication Isotretinoin (Accutane®), are taking antimetabolites for any medical conditions. The safety and effectiveness of this laser for LASIK correction have NOT been established in patients: with progressive refractive errors, ocular disease, corneal abnormality, previous corneal or intraocular surgery, or trauma in the ablation zone, who are taking the medication Sumatriptan (Imitrex®), or Amiodarone hydrochloride (Cordarone®), with corneal neovascularization within 1.0 mm of the ablation zone, over the long term (more than 1 year after surgery for myopia and more than 2 years for mixed astigmatism), for patients who engage in activities that could endanger or damage the LASIK flap, for patients who have a family history of degenerative corneal disease, history of inflammation of the eye, for patients who have a history of crossed eyes (strabismus) or who have undergone strabismus surgery, prior LASIK or Refractive Surgery, with history of any eye diseases or abnormalities such as corneal scars or active disease, and whose BSCVA is worse than 20/20. To reduce the risk of corneal ectasia, the posterior 250 microns (µm) of corneal stroma should not be violated. The treatment of highly myopic eyes necessitates the removal of significant amounts of corneal tissue. The iDESIGN® System calculates the estimated residual bed depth using the pachymetry and intended flap thickness entered by the user. Actual flap thicknesses may vary. If the estimated residual stromal bed is = 320 microns, an in-the-bed pachymetric measurement should be performed.
ADVERSE EVENTS: Possible adverse events include loss of best spectacle corrected visual acuity (BSCVA), serious Transient Light Sensitivity Syndrome, serious primary open angle glaucoma, miscreated flap, melting of the flap, severe glare, and severe dry eyes. Complications can include corneal edema, epithelial ingrowth, diffuse lamellar keratitis, foreign body sensation, and pain.
© 2017 Abbott Medical Optics, Inc. TECNIS Symfony, iDESIGN, CATALYS, WHITESTAR SIGNATURE, LipiScan and LipiFlow are trademarks owned by or licensed to Abbott Medical Optics, Inc., its subsidiaries or affiliates. All other trademarks are the intellectual property of their respective owners. PP2017OTH0817
- "Cataract." https://nei.nih.gov/health/cataract. Accessed November 2017.
- MarketScope: 2016 Dry Eye Products Report: A Global Market Analysis for 2015 to 2021: pg. 56.
- Nichols KK, Foulks GN, Bron AJ, et al. The International Workshop on Meibomian Gland Dysfunction: Executive Summary. Investigative Ophthalmology & Visual Science. 2011;52(4):1922-1929.
- Lemp MA, Crew LA, Bron AJ, et al. Distribution of aqueous-deficient and evaporative dry eye in a clinic-based patient cohort: a retrospective study. Cornea. 2012;31(5):472-478.
Source: Johnson & Johnson
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