LenSx, a form of cataract surgery that uses an advanced laser to make the necessary incision, removes those potential barriers to success and provides a less risky and more precise option for patients with cataracts. J Cataract Refract Surg. May 2018 in COMPLIANCE. 0000052798 00000 n
Auto-capture mode automatically records measurements when the patient is optimally aligned, without requiring any extra steps. The arcuate incisions made by the LenSxLaser are customizable and can be created to an exact 80% depth. New Cars Back Item. Designed for use in both anterior and posterior segment surgeries, the system can assist in a variety of surgical applications beyond phacoemulsification, including coaxial and bimanual irrigation/aspiration, bipolar coagulation, vitrectomy and viscous fluid and air exchange operations. Cataract surgery corrects vision problems by replacing a cloudy lens with a transparent one. At the end of the case, the DMM sends surgical data back to the Vision Planner14: An image of the final IOL position at the end of the case can be captured and stored for future reference.12, Dynamic overlays can help to precisely execute incisions14, Image-guided integration can help to achieve greater capsulorhexis accuracy15, Precisely align toric IOLs according to your planned implantation axis, mapped to your patients unique limbal and iris landmarks14, An image of the final IOL position is captured and stored for future reference12, Disclaimer: (1) These images are for illustrative purposes only and may not reflect the current product and (2) The patient information is hypothetical and not based on real patient data, For relevant training content from industry thought leaders. Nikon AF-S Zoom-Nikkor Instruction Manual. endstream
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Rayon / Hemp. Setup instructions, pairing guide, and how to reset. Mastropasqua L, Toto L, Mastropasqua A, et al.
Through continuous innovation, the LenSx Laser with ASCEND Technology sets the standard at the cornea, capsule and lens, optimizing cataract refractive procedures and consistently hitting refractive targets for the widest range of patients. The LenSx Laser (http://goo.gl/z5OP0t) for refractive cataract surgery has been described as a surgical breakthrough. Only properly trained personnel with experience may operate the device and control software and interpret the results. Request Sample. LENSX LASER SYSTEM OPERATOR'S MANUAL Alcon LenSx, Inc. 33 Journey Aliso Viejo, CA 92656 Date of Issue: January 2011 Alcon Laboratories, Inc. Distrubuted By: 6201 South Freeway Fort Worth, TX 761342099 Alcon Laboratories, UK Ltd. Pentagon Park, Boundary Way Hemel Hempstead Hertfordshire, HP2 7UD, UK DRAFT 0086 fLENSX LASER SYSTEM OPERATOR'S Zhang X, et al. Select below for other countries. Filkorn et al. Femtosecond laser versus manual clear corneal incision in cataract surgery. AI-LenSx Femto Cataract Laser Surgery can correct the cylinder by three ways. China : Does the applicant or authorized agent so certify? 1. All of the statements herein and the Some platforms use a liquid optic interface while others use a soft hydrogel interface, which have differences in fixating the eye during the procedure. Spain 0000018265 00000 n
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Chan T, et al. IdeaPad 3 Series Manual. This edition contains a wide range of articles evaluating current practice and research, as well as innovations that directly affect ophthalmologists. Innovation in the surgical platform technology is ongoing. Name of test firm and contact person on file with the FCC: WILLFUL FALSE STATEMENTS MADE ON THIS FORM ARE PUNISHABLE BY FINE AND IMPRISONMENT The ARGOS Biometer is faster than other market-leading biometers.1-5 With a biometric data capture time of less than1second and a higher scanning speed, 50% faster than IOLMaster* 700, the ARGOS Biometer allows for enhanced efficiency and accuracy of eye measurements.1,9. Uruguay The LenSx Laser System should only be operated by a physician trained in its use. * Requires VERION Digital Marker L (with LenSx). The LenSx Laser, Catalys* and Victus* systems use high-definition optical coherence tomography (HD OCT), while LENSAR* uses Scheimpflug imaging technology. J&J subsequently expanded the case to cover copyright infringement claims and began a parallel challenge to Alcon in Europe. France Predictive accuracy of partial coherence interferometry and swept-source optical coherence tomography for intraocular lens power calculation. Copyright 2023 Touch Medical Media. Shammas HJ, Shammas MC, Jivrajka RV, Cooke DL, Potvin R. Effects on IOL power calculation and expected clinical outcomes of axial length measurements based on multiple vs single refractive indices. Brazil Tamaoki A, Kojima T, Hasegawa A, et al. 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 deformation of the corneal shape. Lens Fragmentation contained in this application pursuant to 47 CFR 0.459 of the Commission Rules? CAUTION: Federal Law restricts this device to sale and use by or on the order of a physician or licensed eye care practitioner. Date of Issue: February 2011. Show all Leica Laboratory Equipment manuals. ChristieCleaning Projector Optics.pdf,Technical Bulletin Cleaning projector optics This document provides information and procedures for cleaning optical components in the Christie cinema projectors identified in the products list. John Davidson, MD, 3085 Loma Vista Road, Ventura, CA 93003, US. 0000004090 00000 n
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Experience complete integration for intelligent planning and empowered execution with enhanced precision at every step. See Prices; Nikon Camera Lens 17-55mm. 64 0 obj
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ISO 5-8. Does this application include a request for confidentiality for any portion(s) of the data Alcon agreed to pay Johnson & Johnson $199 million to settle a dispute over laser-assisted cataract surgery devices. The device is intended 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. 4. "An Evaluation of the Femto Second LenSx assisted Cataract Surgeries compared to normal . * Trademarks are the property of their respective owners. There was also a decrease in central endothelial cell loss.10 A study by Mayer showed significantly less endothelial cell loss with LenSxLaser cases compared to manual phacoemulsification. 9. A full list of approved disinfection agents can be found at www.epa.gov. 0000008360 00000 n
Aperio ImageScope DX. SMARTCataract automatically evaluates patient data and takes surgeon preferences, preferred formulas and lens types to efficiently guide the surgical planning stage. The Patient Interface is intended for single use only. PLoS ONE. ARGOS Biometer has shown better acquisition rates in dense cataract compared to IOLMaster 700 (1), IOLMaster 500 and LENSTAR LS900 (2). J Cataract Refract Surg. It is made from 70% rayon and 30% cellulose. Clinical evaluation of a new swept-source optical coherence biometer that uses individual refractive indices to measure axial length in cataract patients. 4 - Contraindicaciones. Please provide feedback for this on the following(scale 1-5, 1 strongly disagree; 5 strongly agree): Laser cataract surgery (LCS) offers several surgical advantages over manual cataract surgery: the laser fragments the lens and creates corneal incisions and capsulotomies with a level of precision, control and reproducibility unachievable with manual techniques. The interface gently makes contact rather than first fitting a suction ring directly onto the patients eye followed by docking the patient up to the laser objective head.40, Some platforms possess a fixed bed, which can help stabilize the head during image capture and treatment, but brings with it the necessity of moving a patient to another bed for the remainder of the surgery.19. Clinical evaluation of a new swept-source optical coherence biometer that uses individual refractive indices to measure axial length in cataract patients. Pages: 34. To request a consultation, click here: http://goo.gl/AvJ4aa Kerry Solomon, MD1101 Clarity RdMt Pleasant, SC 29464(843) 881-3937 Ecuador In this side-by-side video comparison video, Dr. Robert Weinstock highlights the evolved efficiencies of the LENSAR Laser System and the key differences between procedures performed with the LENSAR Laser versus the LenSx Laser, from patient data entry to toric IOL implantation. Symptoms will worsen & may lead to loss of vision. Uruguay Laser cataract surgery, LenSx Laser, femtosecond laser technology, Several factors point to a potentially precipitous rise in the need for cataract surgery in the near future: population growth, increased awareness of and demand for excellent unaided vision, and the collateral benefits of improved vision after surgery. 5. Accuracy of predicting refractive outcomes using swept-source optical coherence tomography in nuclear cataracts. "H Djd3X$v H(q The LenSx and Catalys laser platforms demonstrate similar capsulotomy outcomes. ZEISS IOLMaster 700 510k Submission 2015. manuals. BUY A NEW CAR ONLINE. In 1996, Dr. Solomon performed the first LASIK procedure in South Carolina. Argentina LenSx Laser System Device Cleaning Date: July 15th 2020 The United States Centers for Disease Control and Prevention (CDC) includes 70% Isopropyl alcohol in its recommendations for disinfecting against COVID-19. *Prospective, multicenter study investigated performance of FLACS at 1 month post-op in Chinese patients (n = 1542 eyes). I have found the OCT imaging useful in revealing lens thickness. Touch Medical Media Group Holdings Limited, a private limited company registered in England and Wales at Lancashire Gate | 21 Tiviot Dale | Stockport | Cheshire | SK1 1TD | UK with registered number 08197142. touchOPHTHALMOLOGY is for informational purposes and intended for healthcare professionals only. It helps us to continually improve our products. VERION Reference Unit User Manual Part I. reported significantly worse corrected distance visual acuity at one month in eyes operated with manual versus laser techniques, which they attributed to the possible inducement of higher-order aberrations secondary to lens tilt in the manual group that could not be corrected with spectacles.13 The authors noted that IOL decentration correlated with changes in manifest refraction at one month and one year after surgery and that capsulotomies created with the LenSx Laser yielded a more stable refractive outcome. Accuracy of IOL power formulas with true axial length versus simulated axial length measurement in 318 eyes using an OCT biometer. By clicking Yes. 2009;25(12):10531060. Clinical evaluation of a new swept-source optical coherence biometer that uses individual refractive indices to measure axial length in cataract patients, Comparing the new SS-OCT biometer ARGOS (OCTB1), which uses individual refractive indices to measure axial length, with the IOLMaster 700 (OCTB2) and OA-2000 (OLCR), which use equivalent refractive index, Shammas HJ, Ortiz S, Shammas MC, Kim SH, Chong C. Biometry measurements using a new large-coherence-length swept-source optical coherence tomographer, Evaluating the repeatability and reproducibility of the measurements obtained with the ARGOS and to compare them with the results obtained with the IOLMaster 500, An Y, Kim H, Joo C-K. SoftFitTM PI uses a soft contact lens insert at the interface to minimize corneal compression. Alcon sponsored the publication of this promotional piece. Hong Kong *Glaucoma is not a contraindication when these procedures are performed using the LenSx. 13. Discard used Patient Interfaces as medical waste. At 3000 A-Lines/sec as compared to 2000 A-Line/sec for IOLMaster* 700 With capture times as low as 0.6 seconds. 0000002723 00000 n
hbbd```b`` She is a consultant to and speaker for Alcon. PLoS One. J&J accused Alcon in 2020 of infringing on 12 of its U.S. patents by selling the LenSx Laser System. But how does it differ from traditional methods for removing cataracts? Future Directions Ophthalmology. Select below for other countries. Use of disposables other than those manufactured by Alcon may affect system performance and create potential hazards. 2017;43:486491. Numerous studies have shown reduced endothelial cell loss and reduced postoperative inflammation with LCS.20,34,35, Roberts et al. Paper presented at: ASCRS; May 5-9, 2017; Los Angeles, CA. 1993 ES300. 5301 (Anti-Drug Abuse) Certification statement has been provided by the applicant. Italy J Cataract Refract Surg. Owner's Manuals Online Repair Manuals We're committed to providing service and repair information in accordance with EU guidelines. Chen X, Chen K, He J, Yao K. Comparing the curative effects between femtosecond laser-assisted cataract surgery and conventional phacoemulsification surgery: a meta-analysis. 7. Chile I continue to believe this technology delivers greatly now and even has the potential to deliver more moving forward. * Requires VERION Digital Marker L (with LenSx, The Alcon Cataract Refractive Suite allows you to experience complete. South Korea 1. VERION Digital Marker M User Manual. They can be under the "exhibits" tab below. Colombia LenSx Crnea. Retrospective chart review of 231 patients for LenSx and manual groups. Kendall Donaldson, MD, MS LenSx user for 4 years Kendall E. Donaldson, MD, MS, is an associate . Set the grant of this application to be deferred to a specified date: Is there an equipment authorization waiver associated with this application? Brazil - Iunderstand that this platform Is directed to Healthcare Professionals only and that I am a licensed Healthcare Professional. at Alcons state-of-the-art training facilities, Hands-on training with Alcon advanced With online access at any time, you can find the information that you need when you need it most. The ARGOS Biometer utilises SS-OCT-enhanced keratometry with angle-to-angle, cornea-to-retina, real-time OCT guidance, allowing the user to monitor patient alignment and fixation and helping acquisition of accurate measurements every time.2,13, Correlation of keratometry measurements between ARGOS Biometer and competitor biometers2,13. Alcon Data on File 2019, report # SD-18-0001-670-01. 2. 0000093732 00000 n
CAS Iberia Team. 2017;43:480485. LCS has been studied in a number of complicated cataract scenarios, including intumescent white cataracts, traumatic cataracts, and eyes with concomitant phacomorphic glaucoma.22,2426, One particular complicated patient type is the posterior pole cataract patient. This review discusses state-of-the-art LCS technologies, how they differ from manual techniques and between platforms, and how this growing sector of LCS will continue to meet the demands of cataract surgery. 2019;19:1-13. The user manual is designed to give you all the inside tips, instructions and general information you need to get the best performance out of your product. This page is available in English. There are important distinctions among the various femtosecond laser platforms that affect surgical technique. * Trademarks are the property of their respective owners. Smart Clock Essential Manual. Offers advanced IOL power calculation with the ability to easily compare formulas and IOLs on the same page, Provides built-in optimisation algorithms to support ongoing personalisation of your SIA and A-constants, Navigate and track every step of your surgery in real time using your patients unique eye landmarks, Step-by-step procedural navigation using CENTURION. Russia, Asia Pacific The LenSx and Catalys laser platforms demonstrate similar capsulotomy outcomes. There are five femtosecond laser platforms approved for use during cataract surgery: LenSx Laser (Alcon); Catalys* (AMO); LENSAR* (LENSAR Inc); Victus* (Bausch & Lomb); and FEMTO LDV Z8* (Ziemer Ophthalmic Systems AG). 2016;42:50-61. Tamaoki A, Kojima T, Hasegawa A, et al. most are cross-trained in multiple specialties, CAS offer assistance with patient application for . Yeu E, et al. J Korean Ophthalmol Soc. Akman A, Asena L, Gngr SG. Smart Clock 2 Manual. Compared to IOLMaster* 700 (1,4), IOLMaster* 500 (2,3), LENSTAR* LS900 (2). A cadaver eye study showed that cataract incisions made with a femtosecond laser were reproducible and stable, and were less likely to leak or become deformed during intraoperative maneuvers as compared to manual incisions.11 Mastropasqua et al. Poor architecture of the main clear corneal incision (CCI) is a primary factor leading to surgically induced astigmatism (SIA), which can have consequences for post-surgical vision.10 The importance of such consequences may be magnified when implanting a multifocal or toric IOL. 4 - Contraindicaciones 5 - Manejo de las complicaciones. have been made with the manufacturer to ensure that production units of this equipment Alcon lensx user manual pdf 1 LENSX LASER SYSTEM OPERATOR S MANUAL Alcon LenSx, Inc. 33 Journey Aliso Viejo, CA USA Date of Issue: February 2011 Distrubuted By: Alcon Laboratories, Inc South Freeway Fort Worth, TX USA Alcon Laboratories, UK Ltd. Pentagon Park, Boundary Way Hemel Hempstead Hertfordshire, HP2 7UD, UK Rev. Select below for other countries. The ARGOS Biometer keratometry measurements show high correlation with IOLMaster* 500, IOLMaster* 700 and LENSTAR*.2,13. Per patient, significant time savings were observed in the following categories15*: Overall, LenSx was significantly faster than CATALYS, with total time savings of 2.86 minutes., * Trademarks are the property of their respective owners. ISO 5-8. The PI design is a critical differentiating factor in the various platforms. 12. B 2 LenSx Laser System 0000089128 00000 n
Laser Cataract SurgeryDefining the Principle Quick Guide Charging the Battery with the Charger Connecting to a Pc. hb```c``YRAbl,`@: Alcon's LenSx Laser. for possession or distribution of a controlled substance. VERION Reference Unit User Manual Part II. 1 and its accessories. Lensx 90 is engineered for extreme softness and for use in the cleaning of delicate lens surfaces. Intraoperative Uses Corneal Incisions Value in Health. Check if a local MyAlcon page for your country to access country product information. however, the applicant remains responsible for all statements in this application. 2017;43:16 21. The remaining characters of the FCC ID, 8065998162, are often associated with the product model, but they can be random. * Compared to IOLMaster 700 (1,4), IOLMaster 500 (2,3), LENSTAR LS900 (2). In an editorial, Alpins and Stamatelatos describe the vector planning approach, [], touchREVIEWS in Ophthalmology. For example, the grantee code for FCC ID: Y5I8065998162 is Y5I. 0000058734 00000 n
The company says the new interface uses a proprietary soft contact lens technology designed to enable the natural curvature of the cornea to conform to a soft contact lens insert, allowing a secure and gentle fit to a patient's eye while minimizing corneal distortion. 2006-2023 Lexus, a Division of Toyota Motor Sales, U.S.A., Inc. All information presented herein is based on data available at the time of posting, is subject to change without notice and pertains specifically to mainland U.S.A. vehicles only (may differ in the state of Hawaii, Puerto Rico, the U.S. Virgin Islands and in other regions). 15. Aperio GT 450. VERION Digital Marker L User Manual. Legion Y520 Tower Series Quick Start Guide. Differences in energy expenditure for conventional and femtosecond-assisted cataract surgery using 2 different phacoemulsification systems. Alcon Laboratories, Inc. 6201 South Freeway Distrubuted By: Fort Worth, TX 76134-2099 USA Alcon Laboratories, UK Ltd. Pentagon Park, Boundary Way Hemel Hempstead Hertfordshire, HP2 7UD, UK. HWk0Gk,Y
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$t}|:|~>EZ*x! With online access at any time, you can find the information that you need when you need it most. Clinical evaluation of a new swept-source optical coherence biometer that uses individual refractive indices to measure axial length in cataract patients. !?+;t>Z -X;WVk5H' >tWs7uR-/7hszE^,! Manual is suitable for 5 more products: Lumix DMC-FX12 DMC-FX10A - Lumix Digital Camera DMC-FX12S - Lumix Digital Camera DMCFX10S - Lumix Digital Camera DMC-FX12K - Lumix Digital Camera. VERION Digital Marker L User Manual. Europe / Middle East / Africa 2018. Jan 15, 2021. LenSx Laser System Bring proven precision and safety to every cataract procedure with the LenSx Laser, featuring ASCEND Technology the market leading femtosecond platform.1-13 Get Started Proven Precision Reproducibility and accuracy at every step.3-7 Compared to manual procedures, LenSx Laser delivers: This page is available in English. It allows for confidence in refractive outcomes even in the case of grade 4+ cataract patients.12. Whang W, Yoo Y, Kang M, et al. Quick Reference Manual Owner's Manual Owner's Manual. 2016;1(1):1-4. 0000006949 00000 n
Accuracy of Predicting Refractive Outcomes Using Swept-source Optical Coherence Tomography in Nuclear Cataracts, Evaluating the accuracy of predicting refractive outcomes of swept-source optical coherence tomography based on biometry (ARGOS; Movu Inc., Santa Clara, CA, USA) in nuclear cataracts, Shammas HJ, Shammas MC, Jivrajka RV, Cooke DL, Potvin R. Effects on IOL Power Calculation and Expected Clinical Outcomes of Axial Length Measurements Based on Multiple vs Single Refractive Indices, Comparing axial length measurements based on multiple specific refractive indices for each segment of the eye to those obtained using a single refractive index for the entire eye and to evaluate the subsequent effects on IOL power calculation, For relevant training content from industry thought leaders, 1.
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k=]dd$pWM))%e:l%t3|ur>Unpl'zTU\\s1DXP The LenSx Laser post- SoftFitTM PI produced the fewest edge anomalies and the highest degree of reproducibility in performing the capsulotomy relative to Catalys* and Victus*.8 Every platform, except the LenSx Laser post-SoftFitTM PI, generated statistically significantly less homogeneous capsulotomies as compared to manually created capsulotomies.8 Regression analysis found the homogeneity of capsulotomies performed with the LenSx Laser post- SoftFitTM PI platform to be similar to those created manually. Sci Rep. 2018;8(1):13732. Singapore. 0000089165 00000 n
It is intended for use by ophthalmologists, physicians, and other eye-care professionals and may only be used under the supervision of a physician. Singapore. Holladay et al. Europe / Middle East / Africa used electron microscopy to analyze the edge characteristics of capsulorhexes cut with manual techniques compared with capsulotomies performed with two generations of the LenSx Laser platform (LenSx Laser pre-SoftFitTM PI version 2.16 and LenSx Laser post-SoftFitTM PI version 2.20), two generations of the Victus* platform (Victus I version 2.5 and Victus II version 2.7SP2), and Catalys* (version 2.15.13). 3 - Instrumentacin y tcnica. Alcon equipment, Made up of tenured ophthalmic technicians JCataract Refract Surg. HVoF~7/t|:/ @c]f{H:c R[)d#eG#yyZUl^IM~"[,ZE@I.2*l6oPz8@RU,$dH4|~e
_OC.0#e ]ED']S;Fyei"/2I"_e3TkJ,T*DiKu#c%fOA!IEK]*C 2019 ASCRS ASOA Annual Meeting. United Kingdom - English, Americas Identifying anatomic landmarks with anterior segment imaging is a critical component of LCS to ensure proper placement of the anterior capsular opening. 142 0 obj
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showed using the LenSx Laser to perform the capsulotomy yielded significantly improved overlap of the capsulotomy and the IOL optic and enabled significantly greater circularity compared to manual techniques.16 In this study, horizontal decentration was >0.4 mm at one week, one month, and one year after surgery in four, three, and five eyes, respectively, in the manual group, and none at all time points in the femtosecond laser group.16 The authors concluded IOL decentration was six times more likely in the manual versus laser group.16 A subsequent study by the same group demonstrated that IOL decentration correlated with changes in manifest refraction at one month and one year after surgery and that capsulotomies created with the LenSx Laser yielded a more stable refractive outcome.13, Bala et al. Hussaindeen JR, Mariam EG, Arunachalam S, et al. 2019;19:7. Available at: http://www.un.org/en/development/desa/population/ publications/pdf/ageing/WorldPopulationAgeing2013.pdf (accessed September 30, 2015). International Journal of Open Access Ophthalmology. Shammas HJ, Ortiz S, Shammas MC, Kim SH, Chong C. Biometry measurements using a new large-coherence-length swept-source optical coherence tomographer. applicable rules, and (3) compliance of the equipment with the applicable technical rules. 0000039391 00000 n
* Trademarks are the property of their respective owners. * This comprehensive tool eliminates the need for complicated online and manual calculations while continuing to optimise patient outcomes with Image Guidance by Alcon.5, * Barrett Total K formula can be used if posterior keratometry is manually entered into the planning software, The ARGOS Biometer captures a reference image of each patients unique eye during measurement. User Manual. Capsulotomy %PDF-1.5
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Is the equipment in this application part of a system Is there a KDB inquiry associated with this application? Spain If an agent has signed this application on behalf of the applicant, a written letter of China Translating several documents such as information sheets, short papers, user manuals and/or safety documents in several international languages ( English - French - German ) Documents were provided by NGO's or organizations within the UN. Posted: 12/18/2018. described a lens fragmentation technique creating concentric circles before aspiration in eyes with posterior polar cataracts.27 Conventional hydrodelineation, referenced in that study, includes a risk for inadvertent cortical cleaving that does not present when using the femtosecond laser. *Based on a real-world, prospective, observational, time-and-motion study with 89 patients undergoing cataract surgery across two surgery centers in the US. May 2019. endstream
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LRI or Limbal Relaxing Incisions. Nikon Micro-Nikkor Camera Lens User Manual. Colombia 2015;41(5):1109-1110. Mayer et al. Click to search Enter search text. that operates with, or is marketed with, another device that requires an equipment authorization? For relevant training content from industry thought leaders, LenSx Laser Important Product Information. I am equally certain the growing body of literature confirms this belief. 1. Tamaoki A, Kojima T, Hasegawa A, et al. You are accessing Alcon's INTERNATIONAL online platform for Healthcare Professionals (MyAlcon). %%EOF
exhibits attached hereto, are true and correct to the best of my knowledge and belief. Mexico Wilcoxon signed rank test. 6. In addition to the application, the FCC also publishes internal images, external images, user manuals, and test results for wireless devices.