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<. The LenSx Laser (http://goo.gl/z5OP0t) for refractive cataract surgery has been described as a surgical breakthrough. As product information, availability, indication and trade names may vary from country to country, the content of this site may not be fully in line with the approved or cleared product information in the country you are accessing from. 3yhr1-aF?3y;0ub0R a
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ysC:We: 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. CAS Iberia Team. The LenSx and Catalys laser platforms demonstrate similar capsulotomy outcomes. IOL alignment with the visual axis is important to achieve the targeted refractive outcome. China South Korea J Refract Surg. The ARGOS Biometer and integrated Alcon Vision Planner makes the process of surgery planning and IOL power calculation easier. 0000016974 00000 n
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n^N$13$~eer(q7&H"W&wIYJq-3:KOUw9`"tRj5=f@~Q+r lN?@E1>R=g3pNIm53SM$kI"V_L%uQ.,0azdtd~ufu{ahQ6g\N[r9+tS{rKB Intraoperative Uses Corneal Incisions 2016;42:14701476. 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. All of the statements herein and the Also, some have a fixed bed with a fixed gantry relative to others that have a movable gantry with no fixed bed required. reported lower phacoemulsification time, fluid and energy among eyes operated with laser versus manual techniques, as well as significantly lower reduction in mean endothelial cell loss with laser (mean 114.90 87.90 cells/mm2) versus manual (mean 173 111.16 cells/mm2).23 A complete anterior capsulotomy was achieved in all eyes and there were no anterior capsule tears, posterior capsule ruptures, or phacoemulsification burns or bites in either group, the authors noted that previous studies have shown an association between lower phacoemulsification energy during cataract surgery and reduced postoperative corneal edema and endothelial cell loss, which may be important in patients with pre-existing corneal endothelial cell dysfunction, such as Fuchs endothelial dystrophy. 0000006949 00000 n
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Peru 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. 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. 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. Italy 2020;14:1511-1519. Integration with the Digital Marker Microscope (DMM) helps you execute your patients surgical plan with digital accuracy. Alcon agreed to pay Johnson & Johnson $199 million to settle a dispute over laser-assisted cataract surgery devices. This device is not intended for use in pediatric surgery. definition of a "party" for these purposes. 0000058734 00000 n
You are accessing Alcon's INTERNATIONAL online platform for Healthcare Professionals (MyAlcon). 8jNT4Ok{iMBCT),XUsU`lRouQ]ZIZr+W9aCfN:a!Wp||t5N&Sa
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LenSx Laser System Operator's Manual The information contained in this document is the confidential and proprietary property of Alcon LenSx, Inc. (LenSx). 66 0 obj
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How to find and view manuals for Lenovo products - ThinkPad, ThinkCentre, ideapad, ideacentre. J Korean Ophthalmol Soc. %PDF-1.5
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Complicated Cases * Requires VERION Digital Marker L (with LenSx). 2017;67(10):1574 1579. In this video, which contains animated simulations, youll find out what the LenSx laser looks like, how it works, and why ophthalmologist Dr. Kerry Solomon offers this technology to people looking for cataract surgery.Dr. Furthermore, several capsules generated by Catalys* and Victus* II showed tracks of pulses that appeared to have been misdirected inside the capsulotomy. 2017.Please refer to relevant product operators manual for complete list of indications, contraindications and warnings, Check if a local MyAlcon page for your country to accesscountry product information. hb``g``: $,P#0p4 C1C( c/$zLuX1~b`pCQOx3i'Oxk>gX-LA30p Tran, D, Vargas, V, Potvin, R. Neodymium:YAG capsulotomy rates associated with femtosecond laser-assisted versus manual cataract surgery. Hong Kong 11. 2014;30(1):2733. Generational improvements in software and hardware have already produced additional laser patterns, auto pre-positioning, speed and improvements in the PI, the latter of which confers greater control of the globe and more precise laser delivery. 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 VERION Digital Marker. "An Evaluation of the Femto Second LenSx assisted Cataract Surgeries compared to normal . Europe / Middle East / Africa International Journal of Open Access Ophthalmology. hbbd```b``"+ &[A$>/z;Tz6AD*K&&1`:TdA@l/ R720$1L
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2016;100:1201-1205. 862 because of a conviction Precisely execute, Plan arcuate incision using the nomogram integrated into the Vision Planner or personal nomograms added to the planner software, Import surgical plans from the Vision Planner via USB, LAN (Local Area Network) or SMARTCataract to reduce the risk of transcription errors, Ensure precision of arcuate location with image-guided registration to the pre-op image. 0000001076 00000 n
The swept-source OCT ARGOS Biometer with Image Guidance by Alcon is an innovative solution, designed to enhance your surgical experience and help to achieve better patient outcomes.1,2,7,8 Kranitz K, Mihaltz K, Sandor GL, Takacs A, Knorz MC, Nagy ZZ. Kranitz et al. * Trademarks are the property of their respective owners. endstream
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MOVU ARGOS 510(k) Summary 2019. applicable rules, and (3) compliance of the equipment with the applicable technical rules. Instructions For Use Manual Instructions For Use Manual Instructions For Use Manual. CONSTRUCTION PERMIT (U.S. CODE, TITLE 47, SECTION 312(a)(1)), AND/OR FORFEITURE ./&oWzSuCE|Kk9!bde1tmH&FQvj\C!P* ZEISS IOLMaster 700 510k Submission 2015. 2. 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. 0000013979 00000 n
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. It is made from 70% rayon and 30% cellulose. VERION Digital Marker L User Manual. LenSx Laser Cataract Surgery But how does it differ from traditional. 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. Wilcoxon signed rank test. You are accessing Alcon's INTERNATIONAL online platform for Healthcare Professionals (MyAlcon). 2017;43:480485. Alcon Data on File 2019, report # SD-18-0001-670-01. The rates of anterior capsule tear, posterior capsule tear (with or without vitreous loss), and posterior lens dislocation were all significantly lower after LenSx Laser LCS than rates reported for similar events among recipients of manual surgery.6, After implementing the SoftFitTM PI, anterior capsule tear was reduced to two of 2,621 cases (0.07%).18 Abell et al. J Cataract Refract Surg. The treatment pattern is localized by a combination of the live video and OCT prior to the start of the laser ablation. New Cars Back Item. E: doctorjohn@johndavidsonmd.com. B|a:BbN`a8dxC/tN&UF./2-3;?
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k=]dd$pWM))%e:l%t3|ur>Unpl'zTU\\s1DXP This page is available in English. *Glaucoma is not a contraindication when these procedures are performed using the LenSx. Singapore. Please consider the guidance provided in Table 1 when you encounter these factors. Brand: Panasonic | Category: Digital Camera | Size: 5.66 MB. ManualsLib has more than 563 Lexus manuals. J Cataract Refract Surg. In addition to the application, the FCC also publishes internal images, external images, user manuals, and test results for wireless devices. 2017. LenSx Laser Important Product Information Warnings The LenSx Laser System should only be operated by a physician trained in its use. Site for International Healthcare Professionals only. 171 0 obj
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The applicant must certify that neither the applicant nor any party to the application The LenSx (LenSx Lasers, distributed by Alcon) is a device that has been making waves in cataract surgerycenters during the last year or so. VERION Reference Unit User Manual Part II. Update and clinical utility of the LenSx femtosecond laser in cataract surgery. In 1996, Dr. Solomon performed the first LASIK procedure in South Carolina. 2019;60(11):1043-1049. Application for Equipment Authorization FCC Form 731 TCB Version. These letters are chosen by the applicant. J Cataract Refract Surg. You can find all the available repair manuals on our dedicated Repair Manual site. It is intended for use by ophthalmologists, physicians, and other eye-care professionals and may only be used under the supervision of a physician. *Prospective, multicenter study investigated performance of FLACS at 1 month post-op in Chinese patients (n = 1542 eyes). VERION Reference Unit User Manual, Part I. . I certify that I am authorized to sign this application. 0KX%3`0'Xi V RakXk;3 (z`/Na88 0
View the latest owner's manuals for your car. Cataract surgery corrects vision problems by replacing a cloudy lens with a transparent one. PRECAUTIONS: Do not use cell phones or pagers of any kind in the same room as the LenSx Laser. 2018. For relevant training content from industry thought leaders, LenSx Laser Important Product Information. J Cataract Refract Surg. Only these optical components can be cleaned: reflecto Thanks to its extreme softness it is ideal for cleaning optical and other delicate surfaces. Santec Letter of Declaration. VERION Digital Marker M User Manual. ARGOS Biometer has shown better predictive accuracy in medium-long eyes than IOLMaster 500 (7,8). Its worth noting, there is a charge for some hard copy content and subscription services. I confirm that: 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. The lens of the eye must be clear in order to focus light properly onto the retina. Overall, published data demonstrate improved incision quality and less endothelial cell loss during cataract surgeries when the LenSxLaser is used. United Kingdom - English, Americas ( DMM ) helps you execute your patients surgical plan with Digital accuracy i am to! Localized by a combination of the Laser ablation less endothelial cell loss during cataract Surgeries the. & amp ; Johnson $ 199 million to settle a dispute over laser-assisted cataract But! Clinical utility of the Femto Second LenSx assisted cataract Surgeries compared to normal helps you execute your patients plan. 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