This live webinar series explores technologies to maximize patient outcomes. Register now to get an in-depth look at the latest in Cataract, Refractive Surgery and Ocular Surface advancements from Johnson & Johnson Vision.
This program is intended for US audiences only.
Shachar Tauber, MD
Learning Objectives:
All participants are Johnson & Johnson Vision Paid consultants.
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 photorefractive keratectomy (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 other 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 with Myopia and Myopic Astigmatism.
INDICATIONS AND IMPORTANT SAFETY INFORMATION LipiFlow® Thermal Pulsation System
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INDICATIONS: The LipiFlow® Thermal Pulsation System is intended for the application of localized heat and pressure therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction (MGD), also known as evaporative dry eye or lipid deficiency dry eye.
CONTRAINDICATIONS: Do not use the LipiFlow® System in patients with the following conditions. Use of the device in patients with these conditions may cause injury. Safety and effectiveness of the device have not been studied in patients with these conditions.
PRECAUTIONS:
Use of the LipiFlow® System in patients with the conditions described in the LipiFlow® instructions for use may result in reduced treatment effectiveness because these conditions may cause ocular symptoms unrelated to cystic meibomian glands and require other medical management. Safety and effectiveness of the device have not been studied in patients with these conditions.
WARNINGS: Caution: Use carefully. May cause serious burns. Do not use over sensitive skin areas or in the presence of poor circulation. The unattended use of the device by children or incapacitated persons may be dangerous.
ADVERSE EVENTS: Onset or increase in eyelid/eye pain requiring treatment procedure discontinuation; eyelid irritation or inflammation; ocular surface irritation or inflammation; and ocular symptoms may occur.
ATTENTION: Reference the LipiFlow Thermal Pulsation System Instructions for Use for a complete listing of indications, warnings, and precautions.
CATALYS Precision Laser System
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INDICATIONS: The Johnson & Johnson Vision, Inc. (JJV) Catalys Precision Laser System is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens. Intended uses in cataract surgery include anterior capsulotomy, phacofragmentation, and the creation of single plane and multi-plane arc cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure. CONTRAINDICATIONS: Should not be used in patients with corneal ring and/or inlay implants, severe corneal opacities, corneal abnormalities, significant corneal edema or diminished aqueous clarity that obscures OCT imaging of the anterior lens capsule, patients younger than 22 years of age, descemetocele with impending corneal rupture, and any contraindications to cataract surgery.
IMPORTANT SAFETY INFORMATION: Mild Petechiae and subconjunctival hemorrhage can occur due to vacuum pressure of the suction ring. Potential complications and adverse events include any of those generally associated with cataract surgery.
CAUTION: Should be used only by qualified physicians who have extensive knowledge of the use of this device and have been trained and certified by Johnson & Johnson Vision, Inc. (JJV).
ATTENTION: Reference the labeling for a complete listing of Important Indications and Safety Information.
INDICATIONS and IMPORTANT SAFETY INFORMATION for TECNIS SYMFONY™ and TECNIS SYMFONY™ TORIC EXTENDED RANGE OF VISION IOLs
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INDICATIONS: 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 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. These models of IOLs, ZXR00, ZXT150, ZXT225, ZXT300, and ZXT375, mitigate the effects of presbyopia by providing an extended depth of focus. Compared to an aspheric monofocal IOL, these models of IOLs provide improved intermediate and near visual acuity, while maintaining comparable distance visual acuity. These models of IOLs are intended for capsular bag placement only.
WARNINGS: Patients with any of the conditions described in the Directions for Use may not be suitable candidates for an intraocular lens because the lens may exacerbate an existing condition, may interfere with diagnosis or treatment of a condition, or may pose an unreasonable risk to the patient’s eyesight. Lenses should not be placed in the ciliary sulcus. May cause a reduction in contrast sensitivity under certain conditions, compared to an aspheric monofocal IOL; fully inform the patient of this risk before implanting the lens. Special consideration should be made in patients with macular disease, amblyopia, corneal irregularities, or other ocular disease. 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: a 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.
PRECAUTIONS: Interpret results with caution when refracting using autorefractors or wavefront aberrometers that utilize infrared light, or when performing a duochrome test. Confirmation of refraction with maximum plus manifest refraction technique is recommended. The ability to perform some eye treatments (e.g. retinal photocoagulation) may be affected by the optical design. Target emmetropia for optimum visual performance. Care should be taken to achieve IOL centration, as lens decentration may result in a patient experiencing visual disturbances under certain lighting conditions.
For the TECNIS Symfony™ Toric IOL, variability in any preoperative surgical parameters (e.g. keratometric cylinder, incision location, surgeon’s estimated surgically induced astigmatism and biometry) can influence patient outcomes. Carefully remove all viscoelastic and do not over-inflate the capsular bag at the end of the case to prevent lens rotation.
SERIOUS ADVERSE EVENTS: The most frequently reported serious adverse events that occurred during the clinical trial of the TECNIS Symfony™ lens were cystoid macular edema (2 eyes, 0.7%) and surgical reintervention (treatment injections for cystoid macular edema and endophthalmitis, 2 eyes, 0.7%). No lens-related adverse events occurred during the trial.
ATTENTION: Reference the Directions for Use for a complete listing of Indications and Important Safety Information.
INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR THE TECNIS TORIC 1-PIECE IOL
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INDICATIONS: The TECNIS® Toric 1-Piece posterior chamber lens is indicated for the visual correction of aphakia and pre-existing corneal astigmatism of one diopter or greater in adult patients with or without presbyopia in whom a cataractous lens has been removed by phacoemulsification and who desire improved uncorrected distance vision, reduction in residual refractive cylinder, and increased spectacle independence for distance vision. The device is intended to be placed in the capsular bag.
WARNINGS: Physicians considering lens implantation should weigh the potential risk/benefit ratio for any circumstances described in the TECNIS® Toric 1-Piece IOL Directions for Use that could increase complications or impact patient outcomes. The clinical study did not show evidence of effectiveness for the treatment of preoperative corneal astigmatism of less than one diopter. The TECNIS® Toric 1-Piece IOL should not be placed in the ciliary sulcus. Rotation of the TECNIS® Toric 1-Piece IOL away from its intended axis can reduce its astigmatic correction. Misalignment greater than 30° may increase postoperative refractive cylinder.
PRECAUTIONS: Accurate keratometry and biometry in addition to the use of the TECNIS® Toric Calculator (www.TecnisToricCalc.com) are recommended to achieve optimal visual outcomes. The safety and effectiveness of the toric intraocular lens have not been substantiated in patients with certain preexisting ocular conditions and intraoperative complications. Refer to the TECNIS® Toric 1-Piece IOL Directions for Use for a complete description of the preexisting conditions and intraoperative complications. All preoperative surgical parameters are important when choosing a toric lens for implantation. Variability in any of the preoperative measurements can influence patient outcomes. All corneal incisions were placed temporally in the clinical study. Do not reuse, resterilize, or autoclave.
ADVERSE EVENTS: The most frequently reported cumulative adverse event that occurred during the TECNIS® Toric 1-Piece IOL clinical trial was surgical re-intervention which occurred at a rate of 3.4% (lens repositioning procedures and retinal repair procedures).
ATTENTION: Reference the Directions for Use labeling for a complete listing of Indications and Safety Information.
INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR THE TECNIS® MULTIFOCAL 1-PIECE AND TECNIS® MULTIFOCAL TORIC II IOLs
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INDICATIONS: The TECNIS® Multifocal 1-Piece intraocular lenses are indicated for primary implantation for the visual correction of aphakia in adult patients with and without presbyopia in whom a cataractous lens has been removed by phacoemulsification and who desire near, intermediate, and distance vision with increased spectacle independence. The TECNIS® Multifocal Toric II lens models ZKU150, ZKU225, ZKU300, ZKU375 and ZLU150, ZLU225, ZLU300, ZLU375 are indicated for primary implantation for the visual correction of aphakia and for reduction of residual refractive astigmatism in adult patients with or without presbyopia, with greater than or equal to 1 diopter of preexisting corneal astigmatism, in whom a cataractous lens has been removed in order to provide near, intermediate and distance vision. The IOLs are intended for capsular bag placement only.
WARNINGS: Physicians considering lens implantation should weight the potential risk/benefit ratio for any conditions described in the Directions for Use that could increase complications or impact patient outcomes. Multifocal IOL implants may be inadvisable in patients where central visual field reduction may not be tolerated, such as macular degeneration, retinal pigment epithelium changes, and glaucoma. The lens should not be placed in the ciliary sulcus. Inform patients about the possibility that a decrease in contrast sensitivity and an increase in visual disturbances may affect their ability to drive a car under certain environmental conditions, such as driving at night or in poor visibility conditions. The clinical study of the TECNIS® Toric 1-Piece IOL did not show evidence of effectiveness for the treatment of preoperative corneal astigmatism of less than one diopter. Rotation of the TECNIS® Multifocal Toric II IOL away from its intended axis can reduce its astigmatic correction. Misalignment greater than 30° may increase postoperative refractive cylinder.
PRECAUTIONS: Prior to surgery, inform prospective patients of the possible risks and benefits associated with the use of this device and provide a copy of the patient information brochure to patient. Secondary glaucoma has been reported occasionally in patients with controlled glaucoma who received TECNIS® Multifocal IOL implants. The long term effects of intraocular lens implantation have not been determined.
Accurate keratometry and biometry in addition to the use of the TECNIS® Toric Calculator (www.TecnisToricCalc.com) are recommended to achieve optimal visual outcomes with TECNIS® Multifocal Toric II IOLs. The safety and effectiveness of the toric intraocular lens have not been substantiated in patients with certain preexisting ocular conditions and intraoperative complications. All preoperative surgical parameters are important when choosing a toric lens for implantation. Variability in any of the preoperative measurements can influence patient outcomes. All corneal incisions were placed temporally in the TECNIS® Toric 1-Piece IOL clinical study. Do not reuse, resterilize, or autoclave.
ADVERSE EVENTS: Only the rate (3.3%) of surgical re-interventions, most of which were non-lens-related, in the ZLB00 (+3.25 D) lens group, was statistically higher than the FDA grid rate (for both first and second eyes). The most frequently reported cumulative adverse event that occurred during the TECNIS® Toric 1-Piece IOL clinical trial was surgical re-intervention which occurred at a rate of 3.4% (lens repositioning procedures and retinal repair procedures).
ATTENTION: Reference the Directions for Use for a complete listing of Indications and Important Safety Information.
