IT S A GLOBAL LEADER. IT S PROVEN.

Transcription

1 isert Preloaded IOL System IT S A GLOBAL LEADER. IT S PROVEN. IT S isert. isert delivers the combination of simple operation, outstanding visual quality, and procedural efficiency.

2 LEADERSHIP, WITH VISION At Bausch + Lomb, we ve consistently demonstrated an unwavering commitment to helping ophthalmic surgeons grow practices and improve patient care. And nowhere is this dedication more evident than in our strong and diversified portfolio of ophthalmic surgical products. By integrating the isert preloaded IOL delivery system into the Bausch + Lomb family of surgical platforms and technologies, that tradition continues. isert PRELOADED IOL DELIVERY SYSTEM Implanted in millions of eyes worldwide, the isert platform delivers the combination of simple operation, outstanding visual quality, and procedural efficiency. isert delivers all the benefits of preloaded technology, including: A GLOBAL MARKET LEADER No time-consuming preparation, cleaning, or sterilization No insertion of lens into the cartridge EXCELLENT IOL DELIVERY PREDICTABILITY No risk of IOL contamination as with open handling No mechanical damage to IOL from contact with instruments No loss of IOL on operating table HIGH-QUALITY VISION WITH AN ASPHERIC BALANCED CURVE (ABC) DESIGN LENS

3 DELIVERY, WITH EASE With outstanding control of IOL delivery, isert provides performance that s both predictable and reproducible. It reduces the time-consuming steps of inserter preparation, cleaning, and sterilization. And its ergonomically-designed twist-style injector facilitates simple, smooth IOL implantation. TRUE THREE-STEP LOADING isert doesn t require multiple actions under each of its master steps. Unlike other such systems, isert delivers three-step loading that only requires three steps Infuse OVD into the injector through the infusion port Press the release tabs to remove the cover from case Push the slider down to remove it from the case

4 INNOVATIVE ABC DESIGN, WITH Square edge design IOLs are associated with minimized posterior capsular opacification (PCO)5 VISIBLE RESULTS The isert lens with proprietary Aspheric Balanced Curve (ABC) design delivers high-quality vision by: Correcting for positive spherical aberration of the cornea1 Aspheric Balance Curve design optic Compensating for decentration1 Reducing coma aberrations1 Providing excellent contrast sensitivity over a wide range of lighting conditions1 Lathe-cut, hydrophobic acrylic Effect of Decentration on Contrast 1 Contrast Spheric Aspheric HOYA Aperture 4.0 mm Spatial freq 50 c/mm Decentration (mm) Reports show the mean value of decentration in a pseudoaphakic eye is mm. 2-4 A MTF study shows isert demonstrates higher performance than both spherical and negative aspheric IOLs within the range of mean decentration. Blue PMMA haptic tips provide increased visualization during lens preparation and implantation

5 isert Delivers Long-term Vision for Your Patients and Your Practice. As a global leader in preloaded IOL Systems with over 4,000,000 procedures 6 isert delivers excellent ease of use, predictability of delivery, and visual quality. And isert delivers a unique negative aspheric lens that compensates for decentration, delivers excellent contrast sensitivity. 1 Combined with the resources and support of Bausch + Lomb, isert can help you achieve outstanding outcomes and continued practice success. SPECIFICATIONS Model Name Recommended Starting A-Constant Overall Diameter Diopter Powers isert * 12.5 mm +6.0 D to +30.0D in 0.5 D steps isert * 12.5 mm +6.0 D to +30.0D in 0.5 D steps isert * 12.5 mm +6.0 D to +30.0D in 0.5 D steps isert * 12.5 mm +6.0 D to +30.0D in 0.5 D steps Characteristics Optic Body Diameter Shape Optic Material Haptic Material 6.0 mm Biconvex Soft Acrylic Model 250 and 251: Soft Acrylic and PMMA Model 230 and 231: PMMA Refractive Index Model 230 and 250: Model 231 and 251: Incision Size Model 250 and 251: Incision as small as 2.4mm *A-constant are estimates only. It is recommended that each surgeon develop his or her own values. Model 230 and 231: Incision as small as 2.65mm INDICATIONS: isert 250 and isert 251 IOL 1-piece lenses are indicated for implantation after extracapsular extraction or phacoemulsification of cataracts in adults. The lens is intended for placement in the capsular bag. WARNINGS: Before implanting isert 250 and isert 251 IOL 1-piece lenses in patients, preoperative evaluation should be performed by a surgeon to consider the potential benefit/risk ratio. PRECAUTIONS: The lens may stiffen due to the ambient temperature; therefore, it is recommended that the lens be left at a temperature of 21 to 25 C for at least 30 minutes. Handle the lens with care to prevent haptic damage due to excessive twisting, strong impact, or excessive pressure. The sodium hyaluronate ophthalmic viscosurgical device (OVD) to be infused into the injector should be allowed to attain room temperature prior to use. After use, discard the injector as medical waste. Do not store the product where exposure to gas may take place. Store at room temperature. Do not resterilize or reuse either the injector or the intraocular lens. ADVERSE EVENTS: The incidence of adverse events experienced during the clinical trial was comparable to or lower than the incidence reported in the historic control ( FDA grid ) population. As with any surgical procedure, there is risk involved. ATTENTION: Refer to the Directions for Use labeling for a complete listing of indications, warnings and precautions, clinical trial information, etc. CAUTION: Federal (USA) law restricts this device to the sale by or on the order of a physician. INDICATIONS: The Hoya isert 230 and isert 231 intraocular lenses (IOLs) are indicated for primary implantation in the capsular bag of the eye for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed. WARNINGS: Physicians considering lens implantation under any of the following circumstances should weigh the potential risk/benefit ratio. PRECAUTIONS: Do not attempt to resterilize the lens as this can produce 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 lens in direct sunlight or at a temperature greater than 25 C / 77 F. Do not autoclave the intraocular lens. ADVERSE EVENTS: Clinical investigation was carried out by the HOYA ispheric Model YA-60BB, which is a parent model for Hoya isert Models 230 and 231 IOLs. The incidence of adverse events experienced during the clinical trial was comparable to, lower than, or not statistically different than the incidence reported in the historic control ( FDA grid ) population. As with any surgical procedure, there is risk involved. ATTENTION: Reference to the Directions for Use labeling for a complete listing of indications, warnings and precautions, clinical trial information, etc. CAUTION: Federal (USA) law restricts this device to the sale by or on the order of a physician. 1. Jackson M. Aspheric Balanced Curve (ABC) IOL technology: an enhanced aspheric effect with better clinical outcomes. Presented at American Society of Cataract and Refractive Surgeons (ASCRS); April 20-24, 2012; Chicago, IL. 2. Oshika T., et al. Influence of tilt and decentration of scleral-sutured intraocular lens on ocular higher-order wavefront aberration. Br J Ophthalmol 2007;91: Rosales P, Marcos S. Phakometry and lens tilt and decentration using a custom-developed Purkinje imaging apparatus: validation and measurements. J Opt Soc Am A Opt Image Sci Vis. 2006;23(3): Baumeister M, Neidhardt B, Strobel J, Kohnen T. Tilt and decentration of three-piece foldable high-refractive silicone and hydrophobic acrylic intraocular lenses with 6-mm optics in an intraindividual comparison. Am J Ophthalmol. 2005;140(6): Buehl W, Findl O. Effect of intraocular lens design on posterior capsule opacification. J Cataract Refract Surg. 2008;34: Data on file. Bausch + Lomb is a trademark of Bausch & Lomb Incorporated or its affiliates. isert is a trademark of Hoya Surgical Optics GmbH used under license Bausch & Lomb Incorporated. H USA.16