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Connecting the dots: Advancements in cataract surgery Copyright 2022 ASCRS Ophthalmic Corporation. All rights reserved. The views expressed in this publication do not necessarily reflect those of the staff and leadership of EyeWorld and ASCRS, and in no way imply endorsement by EyeWorld and ASCRS. © 2022 Alcon Inc. 4/22 US-CLI-2200084 IMPORTANT PRODUCT INFORMATION ARGOS® Optical Biometer Caution: Federal (U.S.) law restricts this device to the sale by or on the order of a physician. Indications: ARGOS® is a non-invasive, non-contact biometer based on swept-source optical coherence tomography (SS-OCT). The device is in- tended to acquire ocular measurements as well as perform calculations to determine the appropriate intraocular lens (IOL) power and type for implantation during intraocular lens placement. Intended Use: The Reference Image functionality is intended for use as a preoperative and postoperative image capture tool. It is intended for use by ophthalmologists, physicians, and other eyecare professionals and may only be used under the supervision of a physician. Warnings and Precautions: Only properly trained personnel with experience may operate the device and control software and interpret the results. Factors that influence the measurement of patients' eyes are listed in the User Manual (Table 1): pseudophakic eye, wearing contact lenses, fixation problem, cornea opacity, non-intact cornea, refractive surgery, blood in the vitreous humor, retinal detachment, keratoconus, asteroid hyalosis, ambient light in the room, and defor- mation of the corneal shape. Please consider the guidance provided in Table 1 when you encounter these factors. Optical Radiation – This device is equipped with a Class 1 laser light source. Attention: Refer to the ARGOS® User Manual for a complete description of proper use and maintenance, optical and technical specifications, as well as a complete list of warnings and precautions. Clareon® Family of IOLs Caution: Federal law restricts these devices to sale by or on the order of a physician. Indication: The family of Clareon® intraocular lenses (IOLs) includes the Clareon® Aspheric Hydrophobic Acrylic and Clareon® Aspheric Toric IOLs, the Clareon® PanOptix® Trifocal Hydrophobic IOL, Clareon® PanOptix® Toric, Clareon® Vivity™ Extended Vision Hydrophobic Pos- terior Chamber IOL and Clareon® Vivity™ Toric IOLs. Each of these IOLs is indicated for visual correction of aphakia in adult patients following cataract surgery. In addition, the Clareon® Toric IOLs are indicated to correct pre-existing corneal astigmatism at the time of cataract surgery. The Clareon® PanOptix® lens mitigates the effects of presbyopia by pro- viding improved intermediate and near visual acuity, while maintaining comparable distance visual acuity with a reduced need for eyeglasses, compared to a monofocal IOL. The Clareon® Vivity™ 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. All of these IOLs are intended for placement in the capsular bag. Warnings/precautions: General cautions for all Clareon® IOLs: Careful preoperative evaluation and sound clinical judgment should be used by the surgeon to decide the risk/benefit ratio before implanting any IOL in a patient with any of the conditions described in the Directions for Use that accompany each IOL. Physicians should target emmetropia, and ensure that IOL centration is achieved. For the Clareon® Aspheric Toric, PanOptix® Toric and Vivity™ Toric IOLs, the lens should not be implanted if the posterior capsule is ruptured, if the zonules are damaged, or if a primary posterior capsulotomy is planned. Rotation can reduce astigmatic correction; if necessary, lens repositioning should occur as early as possible prior to lens encapsulation. For the Clareon® PanOptix® IOL, some visual effects may be expected due to the superposition of focused and unfocused multiple images. These may include some perceptions of halos or starbursts, as well as other visual symptoms. As with other multifocal IOLs, there is a possibility that visual symptoms may be significant enough that the patient will request explant of the multifocal IOL. A reduction in contrast sensitivity as compared to a monofocal IOL may be experienced by some patients and may be more prevalent in low lighting conditions. Therefore, patients implanted with multifocal IOLs should exercise caution when driving at night or in poor visibility conditions. Patients should be advised that unexpected outcomes could lead to continued spectacle dependence or the need for secondary surgical intervention (e.g., intraocular lens replacement or repositioning). As with other multifocal IOLs, patients may need glasses when reading small print or looking at small objects. Posterior capsule opacification (PCO) may significantly affect the vision of patients with multifocal IOLs sooner in its progression than patients with monofocal IOLs. For the Clareon® Vivity™ IOL, most patients implanted with the Vivity™ IOL are likely to experience significant loss of contrast sensitivity as compared to a monofocal IOL. Therefore, it is essential that prospec- tive patients be fully informed of this risk before giving their consent for implantation of the Clareon® Vivity™ IOL. In addition, patients should be warned that they will need to exercise caution when engaging in activities that require good vision in dimly lit environments, such as driving at night or in poor visibility conditions, especially in the presence of oncoming traffic. It is possible to experience very bothersome visual disturbances, significant enough that the patient could request explant of the IOL. In the parent AcrySof® IQ Vivity™ IOL clinical study, 1% to 2% of AcrySof® IQ Vivity™ IOL patients reported very bothersome star- bursts, halos, blurred vision, or dark area visual disturbances; however, no explants were reported. Prior to surgery, physicians should provide prospective patients with a copy of the Patient Information Brochure available from Alcon informing them of possible risks and benefits associated with these IOLs. Attention: Reference the Directions for Use labeling for each IOL for a complete listing of indications, warnings and precautions. Clareon® Aspheric Family of Hydrophobic Acrylic IOLs with the AutonoMe® Automated Pre-loaded Delivery System Caution: Federal law restricts this device to sale by or on the order of a physician. Indication: The Clareon® Aspheric Hydrophobic Acrylic IOLs include the Clareon® Aspheric and Clareon® Aspheric Toric IOLs and are indicated for primary implantation in the capsular bag in the posterior chamber of the eye for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed. In addition, the Clareon® Aspher- ic Toric IOL is indicated to correct pre-existing corneal astigmatism. Warnings/precautions: The Clareon® IOL is intended for implantation in the capsular bag only. Physicians considering lens implantation under any of the following circumstances should weigh the potential risk/ benefit ratio: patients in whom the posterior capsule is ruptured, zonules are damaged, or primary posterior capsulotomy is planned. Careful preoperative evaluation and sound clinical judgment should be used by the surgeon to decide the risk/benefit ratio before implanting the IOL in a patient with any of the conditions described in the Directions for Use. For the Clareon® Aspheric Toric IOLs, rotation can reduce astigmatic correction; if necessary, lens repositioning should occur as early as possible prior to lens encapsulation. As with any surgical procedure, there is risk involved. Potential complica- tions accompanying cataract and/or IOL implantation surgery may in- clude, but are not limited to, the following: lens epithelial cell on-growth, corneal endothelial cell damage, infection (endophthalmitis), toxic anterior segment syndrome (TASS), retinal detachment, vitritis, cystoid macular edema, corneal edema, pupillary block, cyclitic membrane, iris prolapse, hypopyon, anterior uveitis, hyphema, pigment dispersion, posterior capsule opacification, transient or persistent glaucoma, and secondary surgical interventions. Secondary surgical interventions include, but are not limited to: lens repositioning, lens replacement, vitreous aspiration or iridectomy for pupillary block, wound leak repair, and retinal detachment repair. Prior to surgery, prospective patients should be informed of the possible risks and benefits associated with this IOL as well as the risks and ben- efits associated with cataract surgery. After surgery, physicians should provide an implant card to patients regarding the IOL implanted. DO NOT re-sterilize the Clareon® IOL or the AutonoMe® Delivery System by any method. The device is for single use only. Attention: Refer to the Directions for Use labeling for a complete list of indications, warnings and precautions. ORA SYSTEM® Caution: Federal (U.S.) law restricts this device to the sale by or on the order of a physician. Indications: Federal (U.S.) law restricts this device to the sale by or on the order of a physician. Intended Use: The ORA SYSTEM® technology utilizes wavefront aberrometry data to measure and analyze the refractive power of the eye (i.e., sphere, cylinder, and axis measurements) to support cataract surgical procedures. Warnings and Precautions: The following conditions may make it dif- ficult to obtain accurate readings using the ORA SYSTEM® technology: Patients having progressive retinal pathology such as diabetic retinopathy, macular degeneration, or any other pathology that the physician deems would interfere with patient fixation; Patients having corneal pathology such as Fuchs,' EBMD, keratoco- nus, advanced pterygium impairing the cornea, or any other pathol- ogy that the physician deems would interfere with the measurement process; Patients for which the preoperative regimen includes residual viscous substances left on the corneal surface such as lidocaine gel or viscoelastics; Visually significant media opacity, such as prominent floaters or asteroid hyalosis, will either limit or prohibit the measurement process; or Patients having received retro or peribulbar block or any other treatment that impairs their ability to visualize the fixation light. Use of iris hooks during an ORA SYSTEM® technology image capture will yield inaccurate measurements. In addition: Significant central corneal irregularities resulting in higher order aberrations might yield inaccurate refractive measurements. Post-refractive keratectomy eyes might yield inaccurate refractive measurement. The safety and effectiveness of using the data from the ORA SYSTEM® have not been established for determining treatments involving higher order aberrations of the eye such as coma and spherical aberrations. ORA SYSTEM® technology is intended for use by qualified health personnel only. Improper use of this device may result in exposure to dangerous voltage or hazardous laser-like radiation exposure. DO NOT OPER- ATE THE ORA SYSTEM® in the presence of flammable anesthetics or volatile solvents such as alcohol or benzene, or in locations that present an explosion hazard. Attention: Refer to the ORA SYSTEM® Operator's Manual for a complete description of proper use and maintenance, as well as a complete list of contraindications, warnings and precautions.

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