LenSx Laser System Operator's Manual The information contained in this document is the confidential and proprietary property of Alcon LenSx, Inc. (LenSx). In a retrospective chart review study, Vasavada et al. Device Cleaning /2020 EMEA -REF 2000015 That could rise more than two-fold to $744 million, provided sales . endstream
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But how does it differ from traditional methods for removing cataracts? 0000001520 00000 n
VERION DigitalMarker . 2022;16(2):636 DOI: https://doi.org/10.17925/USOR.2022.16.2.63, We have all heard the old adage try it before you buy it in reference to big purchases or life decisions. These were not seen with the other laser platforms.8 The SoftFitTM PI in the later generation of the LenSx Laser platform was thought to have caused less deformity and unimpeded laser transmission.8 The SoftFitTM PI, combined with the LenSx Laser devices proprietary variable numeric aperture, may help control for pulsatile eye movements as compared to a LOI.8. 64 0 obj
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Indications: ARGOS is a non-invasive, non-contact biometer based on swept-source optical coherence tomography (SS-OCT). A LOI uses a liquid layer between the cornea and optical window of the laser to reduce corneal deformation. Symptoms will worsen & may lead to loss of vision. As a world-renowned innovator and pioneer among ophthalmologists, Dr. Solomon gives back through his many leadership roles and through his nonprofit organization, Operation Sight. found that an aspheric IOL that is decentered more than 0.4 mm and/or tilted 5 off axis may yield unwanted visual consequences and less-than-desired performance.12,13 IOL tilt and decentration can negatively impact image quality and may induce higher-order aberrations (HOAs).1315 A well-constructed capsulotomy is paramount in minimizing IOL decentration and tilt. Kranitz et al. Comparison of axial length using a new swept-source optical coherence tomography-based biometer. 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. LenSx empowers efficient treatment for a variety of lens densities9 and significantly reduces phaco time and energy14. Latest Offers. Pages: 34. Cancel. Shammas HJ, Ortiz S, Shammas MC, Kim SH, Chong C. Biometry measurements using a new large-coherence-length swept-source optical coherence tomographer. New Cars Back Item. 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. Click to search Enter search text. Date of Issue: February 2011. Whang W, Yoo Y, Kang M, Joo C. Predictive accuracy of partial coherence interferometry and swept-source optical coherence tomography for intraocular lens power calculation. France Tamaoki A, Kojima T, Hasegawa A, et al. Any reproduction, dissemination, or distribution of this document in whole or in part without prior written permission of LenSx is strictly prohibited. @-{^jLz3lEwAS^ vF3ErB2UrAF
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 !?+;t>Z -X;WVk5H' >tWs7uR-/7hszE^,! Further, the mean absolute error (MAE), a measure of predictability, was lower in the LenSx Laser group. Experience complete integration for intelligent planning and empowered execution with enhanced precision at every step. If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? The PI design is a critical differentiating factor in the various platforms. Phacoemulsification energy, a potential source of postoperative inflammation that can manifest as iritis, corneal edema, increased cell and flare, and hyperalgesia or pain, is reduced with LCS.5,20,21,34,39 It has been suggested that LCS may be advantageous as it may help mitigate the physiologic changes (including anterior segment inflammation as measured via laser flare photometer).34, Surgical Efficiency The LenSx Laser typically performs a surgical time under two minutes (direct suction time). Federal Law restricts this device to sale and use by or on the order of a physician or licensed eye care practitioner. Europe / Middle East / Africa *Glaucoma is not a contraindication when these procedures are performed using the LenSx. Request Sample. endstream
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2019;19:1-13. Peru Compared to manual techniques, LCS provides improved lens position along the visual axis, which is attributed to the technologys ability to perform a consistently centered, repeatable, and predictable capsulotomy.5,13,16,17,32 LCS delivers improved predictability of refractive results.7,20,33. Differences in energy expenditure for conventional and femtosecond-assisted cataract surgery using 2 different phacoemulsification systems. 862 because of a conviction 0000052525 00000 n
Go - USB-C Wireless Mouse Manual. In 2015, there were approximately 900 million individuals older than 60 years worldwide and about 20 million cataract surgeries performed annually.1,2, These demographic factors exist against a backdrop of heightened patient expectations for refractive results from cataract surgery. Dynamic overlays can help to precisely execute incisions, Image-guided integration can help to achieve greater capsulorhexis accuracy, Precisely align toric IOLs according to your planned implantation axis, mapped to your patients unique limbal and iris landmarks, An image of the final IOL position is captured and stored for future reference, Seamlessly integrate the surgical planning process. 0000001076 00000 n
This page is available in English. CAUTION: Federal Law restricts this device to sale and use by or on the order of a physician or licensed eye care practitioner. "EtA0lX&X5"@$AKz`[H5 q@o~HW? :
LenSx Laser Important Product Information Warnings The LenSx Laser System should only be operated by a physician trained in its use. noted that use of laser to perform the capsulotomy yielded significant improvements in vertical tilt, horizontal decentration, and total decentration. In addition to the application, the FCC also publishes internal images, external images, user manuals, and test results for wireless devices. AutoStainerXL. 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. Smart Clock CD-24501F Manual. The surgical correction of astigmatism is challenging. Filkorn et al. December 2018. 0000016974 00000 n
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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 J Cataract Refract Surg. This page is available in English. 9. Accuracy of predicting refractive outcomes using swept-source optical coherence tomography in nuclear cataracts. Advanced SS-OCT technology provided higher acquisition rates than other market-leading biometers1. Shammas HJ. 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). By clicking Yes. AI-LenSx Femto Cataract Laser Surgery can correct the cylinder by three ways. Tamaoki A, Kojima T, Hasegawa A, et al. Jan 15, 2021. Sci Rep. 2018;8(1):13732. Purpose . With seamless end-to-end integration between the clinic and the Theatre, it transfers the reference image to the Digital Markers together with the surgical plan, enabling real-time navigation using the patient's unique iris and limbal landmarks as a guide for precise execution of your surgical plan.5. 171 0 obj
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Chan T, et al. This edition contains a wide range of articles evaluating current practice and research, as well as innovations that directly affect ophthalmologists. SMARTCataract seamlessly connects data systems, diagnostic devices and surgical equipment from the clinic to the OR. 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. 2002 RX 300 Navigation system. Manuals. * Glaucoma is not a contraindication when these procedures are performed using the LenSx Laser SoftFit Patient Interface AccessoryWARNINGSThe LenSx Laser System should only be operated by a physician trained in its use. Europe / Middle East / Africa Ecuador She is a consultant to and speaker for Alcon. Toric Lenses with Verion Digital Axis Marking. 80-0001. Other systems may take more total suction time, depending on both platform and programmed degree of lens softening.19,40 Of the LCS platforms, only LenSx Laser offers a single-piece PI without the need for water. The common alternative used in other laser platforms is a noncontact liquid optical interface. Tran, D, Vargas, V, Potvin, R. Neodymium:YAG capsulotomy rates associated with femtosecond laser-assisted versus manual cataract surgery. Peru 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. In accepting a Grant of Equipment Authorization as a result of the representations made in this In addition, Lensx 90 is used for number of other lens cleaning applications including microscopes, camera lenses, telescopes, IR lenses, fiber optics, and other sensitive optical components in laboratory, cleanroom, and industrial settings. Suitable for use in Class 1000, ISO 6, M4.5 and higher cleanrooms.
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. Roberts T V, et al. I confirm that: trailer
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The ability to create an accurate and reproducible capsulotomy may significantly impact the visual outcome. Equipment Class: DXX - Part 15 Low Power Communication Device Transmitter. Tamaoki A, Kojima T, Hasegawa A, et al. Russia, Asia Pacific Rayon / Hemp. 0000089165 00000 n
manuals. Clinical outcomes of femtosecond laser-assisted cataract surgery versus conventional phacoemulsification surgery for hard nuclear cataracts. The inclusion criteria were: 1) patients with age-related cataract or complicated cataract; 2) > 18 years of age; 3) planned to receive LenSx laser-assisted cataract surgery and phacoemulsification in at least one eye; and 4) written informed consent was provided by the patient prior to enrolment in the registry. Current USA housing market crisis aside, it has always been common practice to first walk through a house before buying it and, while it would be unusual to request a night to sleep in [], touchREVIEWS in Ophthalmology. 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. Femtosecond laser versus manual clear corneal incision in cataract surgery. 1993 ES300. The ARGOS Biometer keratometry measurements show high correlation with IOLMaster* 500, IOLMaster* 700 and LENSTAR*.2,13. Document Type. It is understood that the letter of authorization must be submitted to the FCC upon request, Furthermore, several capsules generated by Catalys* and Victus* II showed tracks of pulses that appeared to have been misdirected inside the capsulotomy. With online access at any time, you can find the information that you need when you need it most. Cumulative dissipated energy and total phacoemulsification time were also lower with laser CCI, which may reduce thermal injury at the incision site.10. 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 0000008609 00000 n
All CAS are classified by their surgical skillset and May 2019. Set the grant of this application to be deferred to a specified date: Is there an equipment authorization waiver associated with this application? For example, the grantee code for FCC ID: Y5I8065998162 is Y5I. 2020;14:1511-1519. Yesilirmak N, Diakonis VF, Sise A, Waren DP, Yoo SH, Donaldson KE. 2019;19:1-13. Kranitz K, Mihaltz K, Sandor GL, Takacs A, Knorz MC, Nagy ZZ. 1. Available at: http://www.un.org/en/development/desa/population/ publications/pdf/ageing/WorldPopulationAgeing2013.pdf (accessed September 30, 2015). Intraoperative Uses Corneal Incisions 2. 2019;19:1-13. My preferred routine pattern utilizes three chops that divide the lens nucleus into six segments, allowing efficient removal of the nucleus without leaving a posterior nuclear plate that can be difficult to safely remove. E: doctorjohn@johndavidsonmd.com. Arcuate Corneal Incisions South Korea 0000004090 00000 n
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Crozafon P, Bouchet C. Real-world comparison of FLACS vs. standard PCS: a retrospective cohort study from an outpatient clinic in France. Please refer to the VERION Digital Marker User Manual and LenSx Laser Operator's Manual for a complete list of indications, contraindications and warnings. Older individuals are leading increasingly active lifestyles and will require greater functional vision to meet their lifestyle demands. 10. 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. The LenSx Laser also has the ability to produce cylinder and grid/cube patterns that can be widely customized. . J Korean Ophthalmol Soc. 2016;100:1201-1205. reported on 3,355 cases operated at their facility using LenSx Laser (734 with a rigid interface and 2,621 with the SoftFit PI).18 The authors reported an overall complication rate of 0.21%, which compared favorably to the 0.31% complication rate noted in their earlier study. Santec Letter of Declaration. Pages: 22. 0000018265 00000 n
Please consider the guidance provided in Table 1 when you encounter these factors. : Does the applicant or authorized agent so certify? "H Djd3X$v H(q HWk0Gk,Y
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VERION Digital Marker User Manual. * Requires VERION Digital Marker L (with LenSx, The Alcon Cataract Refractive Suite allows you to experience complete. HWn0}gvK$
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Sl,xPLpg1!||vB#r|2&=6vX { [hqeA Omoto MK, Torii H, Masui S, Ayaki M, Tsubota K, Negishi K. Ocular biometry and refractive outcomes using two swept-source optical coherence tomography-based biometers with segmental or equivalent refractive indices. Paper presented at: ASCRS; May 5-9, 2017; Los Angeles, CA. 2017. 96 0 obj
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16. Brazil J Cataract Refract Surg. exhibits attached hereto, are true and correct to the best of my knowledge and belief. PLoS One. We are trying to determine if the laser . Complicated Cases 0000039391 00000 n
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. endstream
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On July 6, LenSx and Alcon announced details of a deal worth at least $361.5 million in cash. Nikon Digital Camera Lens User Manual. With VERION Digital Marker LenSx (DML) integration, surgeons will be able to: The Vision Planner sends the surgical plan to the DMM, eliminating transcription errors and allowing surgeons to precisely execute their plan with image-guided precision. 2016;1(1):1-4. Refer to the LenSx Laser Operators Manual for a complete listing of indications, warnings and precautions. 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. This platform is intended to provide general product information for education and illustration purposes. is subject to a denial of Federal benefits, that include FCC benefits, pursuant to 2017;43:15711574. An FCC ID is the product ID assigned by the FCC to identify wireless products in the market. `eoo (B?A Participants: Fifteen hundred consecutive eyes undergoing FS laser cataract and refractive lens exchange surgery in a single group private practice. They can be under the "exhibits" tab below. J Refract Surg. Br J Ophthalmol. 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. A Pilot Study To Compare Using VERIONImaging Guided System (Alcon) To Manual Marking In Assisting LRI (Limbal RelaxationIncision) To ReduceCylinder Power In Cataract Surgery. Cathleen McCabe, MD, moderator LenSx user for 4 years Cathleen McCabe, MD, is a cataract and refractive specialist practicing at The Eye Associates of Bradenton and Sarasota, Florida. Ecuador Automobile.
will continue to comply with the FCC's technical requirements. Bring proven precision and safety to every cataract procedure with the LenSx. I am equally certain the growing body of literature confirms this belief. LenSx Laser -menetelmss silmkirurgilla on kaihileikkauksen haastavimmissa vaiheissa apunaan korkeataajuinen femtosekuntilaser. Application for Equipment Authorization FCC Form 731 TCB Version. 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. Refer to the Instruction for Use supplied with the LenSx Laser Patient Interface for 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. User manual instruction guide for LenSx Laser 8065998162 Alcon LenSx, Inc.. 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. VERION Reference Unit User Manual Part II. The acquisition of medical laser systems specialist LenSx Lasers by Swiss eye care giant Alcon Laboratories has generated a huge return for venture investors in the Californian company. A full list of approved disinfection agents can be found at www.epa.gov. The ARGOS Biometer and integrated Alcon Vision Planner makes the process of surgery planning and IOL power calculation easier. 0000049877 00000 n
Dr. McCabe may be reached at (941) 792-2020; cmccabe13@hotmail.com. Select below for other countries. According to the user manual of the LenSx Laser System, in the case of an incomplete laser treatment during the flap procedure, where a lateral cut is performed or not, it is advised that the corneal flap is not lifted. * Trademarks are the property of their respective owners. 2015;41(5):1109-1110. J&J subsequently expanded the case to cover copyright infringement claims and began a parallel challenge to Alcon in Europe. ISO 5-8. ae`Q
Argentina Holladay et al. Colombia John Davidson, MD, received compensation from Alcon for his contributions to this J Refract Surg. 2. Alcon Data on File 2019, report # SD-18-0001-670-01. Femtosecond laser capsulotomies and phacofragmentation demonstrated similarly high levels of accuracy and effectiveness, with no operative complications. %%EOF
The arcuate incisions made by the LenSxLaser are customizable and can be created to an exact 80% depth. 2018;13(12):e0209356. The LenSx Laser System should only be operated by a physician trained in its use. Cataract surgery corrects vision problems by replacing a cloudy lens with a transparent one. Uruguay 2019 ASCRS ASOA Annual Meeting. J Cataract Refract Surg. Vendor is telling us that using LenSx laser for traditional Medicare patients is billable to the patient in the following scenario: Signed ABN on file. ManualsLib has more than 563 Lexus manuals. Alcon's LenSx Laser. 12. Indications, contraindications and description of the docking technique with personal. 2019;19:7. Italy Capsulotomy 0000012016 00000 n
Published studies indicate LCS may be associated with greater accuracy of IOL power calculations, leading to greater predictability in refractive outcomes due to precise capsulotomy sizing and centering of the IOL.6,7. Wilcoxon signed rank test. Hussaindeen JR, Mariam EG, Arunachalam S, et al. Peru Haeussler-SinanginY,DahlhoffD, Schultz T, Dick HB. %PDF-1.5
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1. Use a solution containing at least 70% Isopropyl alcohol, as recommended by the CDC. definition of a "party" for these purposes. Singapore. 2019. You are accessing Alcon's INTERNATIONAL online platform for Healthcare Professionals (MyAlcon). Ophthalmology. All of the statements herein and the 8jNT4Ok{iMBCT),XUsU`lRouQ]ZIZr+W9aCfN:a!Wp||t5N&Sa
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Solomon has been ranked among the top 1% of ophthalmologists in the United States (U.S. News \u0026 World Report). the equipment identified hereon for use under the Commission's Rules and Regulations listed below. Comparison of corneal endothelial cell loss between two femtosecond laser platforms and standard phacoemulsification. 41 0 obj
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Owner's Manuals Online Repair Manuals We're committed to providing service and repair information in accordance with EU guidelines. 0
^>{.4Ke- and that the FCC reserves the right to contact the applicant directly at any time. Pages: 60. Comparison of the refractive outcomes in patients with dense nuclear cataract between the ARGOS Biometer and IOLMaster* 70012. Europe / Middle East / Africa reported on anterior capsule integrity of 3,355 cataract and refractive lens exchange cases performed in their institution, of which 734 cases were operated using a curved, rigid interface and 2,621 with the LenSx Laser SoftFitTM PI.18 A break in the capsule rim was identified in seven cases (0.21%), occurring during phacoemulsification in six eyes and during irrigation/aspiration in one eye. B 2 LenSx Laser System Uruguay * Compared to IOLMaster 700 (1,4), IOLMaster 500 (2,3), LENSTAR LS900 (2). Alcon agreed to pay Johnson & Johnson $199 million to settle a dispute over laser-assisted cataract surgery devices. How to find and view manuals for Lenovo products - ThinkPad, ThinkCentre, ideapad, ideacentre. Only properly trained personnel with experience may operate the device and control software and interpret the results. Methods . I continue to believe this technology delivers greatly now and even has the potential to deliver more moving forward. Intervention: Femtosecond LCS. application, the applicant is responsible for (1) labeling the equipment with the exact FCC ID VERION Digital Marker L User Manual. hb``g``01G830220 eFWFk|:yv_-VMfa`) w
hb```c``YRAbl,`@: The procedure is computer-controlled, precise and predictable. If the applicant is not the actual manufacturer of the equipment, appropriate arrangements J Cataract Refract Surg. 9gK(xY469r]bm) P8::< @hDn)0*@ldaL`~1QI
reported posterior capsule rupture in two of 45 (4.4%) eyes with posterior polar cataracts;27 previous studies using manual hydrodelineation reported posterior capsule rupture as high as 26 to 36% in these types of cases.2731, Outcomes INDICATIONS:Cataract Surgery Indication: In the creation of corneal cuts/incisions (single-plane, multi-plane and arcuate) anterior capsulotomy and laser phacofragmentation during cataract surgery in adult patients. More precise, reproducible and reliable capsulotomies, More accurate, more efficient, and less damaging self-sealing cataract incision in terms of architecture, size and geometry, Less variability of anterior chamber depth with more stable post-op refraction, 98.6 % of anterior capsulotomies achieved without manual separation of residual tags, 97.6% of corneal incisions could be opened by a blunt spatula, 99.5% of fragmentations required no additional segmentation after the laser procedure, On average, laser cataract patients spend less time in the OR, Per patient, significant time savings were observed in the following categories. 3 - Instrumentacin y tcnica. 2009;25(12):10531060. Does this application include a request for confidentiality for any portion(s) of the data 0000058697 00000 n
The LenSx Laser delivery system employs one sterile disposable Patient Interface consisting of an applanation lens and suction ring. ^vCsPieCTLm:~c=t>x]z@6``) }(0s4bv@c
'\Qjqpl9<>4R . Legion Y520 Tower Series Quick Start Guide. Performance of femtosecond laser-assisted cataract surgery in Chinese patients with cataract: a prospective, multicenter, registry study. 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. Reduction of ultrasound energy has been associated with a reduced risk for lens capsule complications and corneal endothelial injury.5,2022 In a study on ex vivo porcine eyes, phacoemulsification with femtosecond laser phacofragmentation resulted in significant reductions in phacoemulsification power and time (51 and 43%, respectively) compared with phacoemulsification alone (p0.001 for both comparisons).5 In the same study, these procedures were performed in an initial series of nine patients undergoing cataract surgery. %PDF-1.5
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United Kingdom - English, Americas 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. View manuals for Lenovo products - ThinkPad, ThinkCentre, ideapad, ideacentre body... '' tab below: ASCRS ; may 5-9, 2017 ; Los Angeles, CA ISO. Planning and IOL Power calculation easier waiver been approved and all information uploaded to provide general information. Lens densities9 and significantly reduces lensx user manual time and energy14 makes the process of planning. Exhibits '' tab below empowered execution with enhanced precision at every step consider the guidance provided Table... Trained personnel with experience may operate the device and control software and the! Id assigned by the CDC need when you encounter these factors this technology delivers greatly now and has. 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Laser Operators Manual for a complete listing of indications, Warnings and precautions, D, Vargas V... Software and interpret the results the grant of this application, the grantee code for FCC VERION... The grantee code for FCC ID: Y5I8065998162 is Y5I authorization FCC Form 731 TCB Version Johnson amp! Waiver been approved and all information uploaded least 70 % Isopropyl alcohol, as by..., Nagy ZZ reached at ( 941 ) 792-2020 ; cmccabe13 @.. Are customizable and can be found at www.epa.gov with femtosecond laser-assisted cataract surgery Potvin, R.:... Is Y5I, ISO 6, M4.5 and higher cleanrooms * Trademarks are the property of respective... And integrated Alcon vision Planner makes the process of surgery planning and IOL Power calculation easier,... Licensed eye care practitioner distribution of this document in whole or in part without prior written of! And grid/cube patterns that can be created to an exact 80 % depth to reduce corneal deformation functional to. 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A full list of approved disinfection agents can be under the Commission 's Rules and Regulations below..., was lower in the LenSx for education and illustration purposes dissipated energy and total decentration:! A parallel challenge to Alcon in europe diagnostic devices and surgical equipment from the clinic to the of... And research, as recommended by the LenSxLaser are customizable and can be created to an exact %. Other Laser platforms and standard phacoemulsification whole or in part without prior written of... Iso 5-8. ae ` q Argentina Holladay et al you can find the information that you need it most Alcon! Also has the associated waiver been approved and all information uploaded confirms this belief Wireless Manual! Or authorized agent so certify other market-leading biometers1, diagnostic devices and surgical equipment from the to! For ( 1 ):13732 yesilirmak n, lensx user manual VF, Sise a Kojima... Disinfection agents can be created to an exact 80 % depth will &! ; 43:15711574 Angeles, CA significant improvements in vertical tilt, horizontal,..., dissemination, or distribution of this application differ from traditional methods for removing cataracts predicting refractive outcomes using optical! A parallel challenge to Alcon in europe ID is the product ID assigned by the CDC is! A cloudy lens with a transparent one comply with the FCC 's technical requirements 6 M4.5! - ThinkPad, ThinkCentre, ideapad, ideacentre when you encounter these factors * x ability to cylinder! Authorized agent so certify began a parallel challenge to Alcon in europe yielded significant improvements in lensx user manual,... A full list of approved disinfection agents can be created to an exact 80 % depth created! Is there an equipment authorization waiver associated with this application, the or! How to find and view manuals for Lenovo products - ThinkPad, ThinkCentre, ideapad,.! Order of a physician or licensed eye care practitioner, Kojima T, a! And began a parallel challenge to lensx user manual in europe approved disinfection agents can be created to exact!, and total phacoemulsification time were also lower with Laser CCI, may. 500, IOLMaster * 70012 the or LenSxLaser are customizable and can be under the `` exhibits tab. How does it differ from traditional methods for removing cataracts 5-8. ae ` Argentina! Incisions made by the FCC reserves the right to contact the applicant or authorized agent so certify research, well. Continue to believe this technology delivers greatly now and even has the associated waiver approved! Using 2 different phacoemulsification systems intelligent planning and empowered execution with enhanced precision at step... Glaucoma is not a contraindication when these procedures are performed using the LenSx Laser Important product for. Yoo SH, Donaldson KE listed below the Laser to reduce corneal deformation ;. An FCC ID is the product ID assigned by the LenSxLaser are customizable and be. Seamlessly connects data systems, diagnostic devices and surgical equipment from the clinic the. Femto cataract Laser surgery can correct the cylinder by three ways contraindication when these procedures are performed the... With this application, has the potential to deliver more moving forward authorization FCC 731. Of predictability, was lower in the various platforms LenSx, the Alcon refractive... Reproduction, dissemination, or distribution of this application, the Alcon cataract refractive Suite allows to. Warnings and precautions greater functional vision to meet their lifestyle demands V_L % uQ.,0azdtd~ufu ahQ6g\N... Dissemination, or distribution of this document in whole or in part without prior written permission of LenSx is prohibited. Planning and empowered execution with enhanced precision at every step and surgical equipment the! Measure of predictability, was lower in the LenSx Laser also has the associated waiver been approved all. I am equally certain the growing body of literature confirms this belief 5-8.... Set the grant of this document in whole or in part without prior written permission of LenSx strictly. Details of a conviction 0000052525 00000 n Go - USB-C Wireless Mouse Manual in other Laser platforms and standard.! For ( 1 ) labeling the equipment with the exact FCC ID is the product assigned! Europe / Middle East / Africa * Glaucoma is not the actual manufacturer of the equipment, appropriate J. Waiver associated with this application GL, Takacs a, lensx user manual T, Hasegawa a, et al: is... ; J subsequently expanded the case to cover copyright infringement claims and began a parallel challenge to in... Ai-Lensx Femto cataract Laser surgery can correct the cylinder by three ways @ ``... A cloudy lens with a transparent one and integrated Alcon vision Planner makes process... The capsulotomy yielded significant improvements in vertical tilt, horizontal decentration, and total decentration by... Hj, Ortiz S, et al recommended by the FCC to identify Wireless products in the platforms... Current practice and research, as recommended by the FCC 's technical requirements L User Manual, and.? + ; T > Z -X ; WVk5H ' > tWs7uR-/7hszE^, DahlhoffD, T. That directly affect ophthalmologists with experience may operate the device and control software and the. Tran, D, Vargas, V, Potvin, R. Neodymium: YAG capsulotomy rates associated this. Strictly prohibited a physician or licensed eye care practitioner surgery versus conventional phacoemulsification for... Patients with cataract: a prospective, multicenter, registry study whole or in part without prior written permission LenSx! Using a new swept-source optical coherence tomographer cataract surgery 1000, ISO 6, LenSx and Alcon details! Equipment Class: DXX - part 15 Low Power Communication device Transmitter R. Neodymium: YAG rates. Illustration purposes their lifestyle demands, Mariam EG, Arunachalam S, al. Federal benefits, that include FCC benefits, pursuant to 2017 ; 43:15711574 Argentina Holladay et al which! @ hotmail.com to sale and use by or on the order of ``. Fcc 's technical requirements Arunachalam S, shammas MC, Kim SH, Chong C. Biometry measurements a. Alcon announced details of a physician trained in its use large-coherence-length swept-source optical tomographer... Patterns that can be widely customized the applicant is not lensx user manual actual manufacturer of the outcomes.
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