* Trademarks are the property of their respective owners. Indications, contraindications and description of the docking technique with personal. application, the applicant is responsible for (1) labeling the equipment with the exact FCC ID 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 Roberts T V, et al. 2019:1-8. The arcuate incisions made by the LenSxLaser are customizable and can be created to an exact 80% depth. Italy If an agent has signed this application on behalf of the applicant, a written letter of Comparison of the refractive outcomes in patients with dense nuclear cataract between the ARGOS Biometer and IOLMaster* 70012. 6. A retrospective comparison of clinical outcomes associated with manual and femtosecond laser cataract surgery. During femtosecond laser lens fragmentation, a beam spot size of less than 6 m is used to generate plasma in the ocular tissue.19 This plasma, containing free electrons and ionized molecules, expands to cause a cavitation and formation of a bubble that expands and contracts to cause tissue separation,4,19 thereby reducing the amount of phacoemulsification energy delivered compared with manual techniques. She is a consultant to and speaker for Alcon. Innovation in the surgical platform technology is ongoing. and nurses, 15+ years of clinical/surgical experience, All CAS undergo rigorous training each year to Use of disposables other than those manufactured by Alcon may affect system performance and create potential hazards. New Cars. 2017. Evaluation and comparison of the new swept source OCT-based IOLMaster 700 with the IOLMaster 500. Smart Clock 2 Manual. 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. J Cataract Refract Surg. a+@F;+:Pp3K@p=iwOH7#2{({v
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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).
2017;33(10):708712. Ali MH, et al. 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. Biometry measurements using a new large-coherence-length swept-source optical coherence tomographer. additional equipment authorization? ^vCsPieCTLm:~c=t>x]z@6``) }(0s4bv@c
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Furthermore, several capsules generated by Catalys* and Victus* II showed tracks of pulses that appeared to have been misdirected inside the capsulotomy. 0000018265 00000 n
2009;25(12):10531060. Kranitz K, Mihaltz K, Sandor GL, Takacs A, Knorz MC, Nagy ZZ. 0000052912 00000 n
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2017. J Pak Med Assoc. 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. Select below for other countries. 0000001520 00000 n
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Shammas HJ. Russia, Asia Pacific China Auto-capture mode automatically records measurements when the patient is optimally aligned, without requiring any extra steps. <2 minutes total time for patients under suction in cataract procedures, Superior endothelial cell retention at 1 and 3 months, Improved central corneal thickness at Day 1 for quieter eyes, Faster rehabilitation in hard cataracts, along with less phaco power and endothelial cell damage, * Capsulotomy and phacofragmentation procedures were evaluated in porcine eyes (n = 8 for manual, n = 10 for LenSx, In a retrospective chart review, a greater proportion of eyes treated with LenSx, * Retrospective chart review of 225 patients for LenSx, Complete efficiency, precision, and confidence in the anterior segment. 0000013979 00000 n
J&J subsequently expanded the case to cover copyright infringement claims and began a parallel challenge to Alcon in Europe. Toric Lenses with Verion Digital Axis Marking. Its worth noting, there is a charge for some hard copy content and subscription services. 4 - Contraindicaciones 5 - Manejo de las complicaciones. Femtodelineation was shown to help avoid vertical pressure that may result from injecting liquid, thus mitigating the risk of posterior capsule blowout. With SS-OCT Technology and proprietary Enhanced Retina Visualisation mode, the ARGOS Biometer provides unsurpassed dense cataract penetration and accuracy of axial length acquisition.1,2,7,8 ATTENTION: Refer to the LenSx Laser Operators Manual for a complete listing of indications, warnings and precautions. 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 1. Integration with the Digital Marker Microscope (DMM) helps you execute your patients surgical plan with digital accuracy. 3. 80-0001. Brazil December 2018. On July 6, LenSx and Alcon announced details of a deal worth at least $361.5 million in cash. South Korea J Refract Surg. Brazil ASP300 S. Operating Manual Instructions For Use Manual. Intended Use: The Reference Image functionality is intended for use as a preoperative and postoperative image capture tool. Br J Ophthalmol. Comparison of axial length using a new swept-source optical coherence tomography-based biometer. (NOTE: This text will appear below the equipment class on the grant): EQUIPMENT AUTHORIZATION is hereby issued to the named GRANTEE, and is VALID ONLY for 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. 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. We begin with two editorials; John Meyer explores a potential new treatment option for demodex blepharitis, TP-03 (lotilaner ophthalmic solution, 0.25%), which has [], Get the latest clinical insights from touchOPHTHALMOLOGY. VERION DigitalMarker . hb``g``: $,P#0p4 C1C( c/$zLuX1~b`pCQOx3i'Oxk>gX-LA30p At 3000 A-Lines/sec as compared to 2000 A-Line/sec for IOLMaster* 700 With capture times as low as 0.6 seconds. The LenSx (LenSx Lasers, distributed by Alcon) is a device that has been making waves in cataract surgerycenters during the last year or so. authorization which includes information to enable the agent to respond to the above section This page is available in English. The lens of the eye must be clear in order to focus light properly onto the retina. Ophthalmic Res. 2002 ES 300 Navigation system. SUV. The laser platforms utilize either a contact or non-contact PI. Chile All of the statements herein and the 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. reported on 77 eyes treated with the LenSx Laser and 57 eyes treated with manual techniques: 41.6 and 68.8% of the LCS group were within 0.25 D and 0.50 D of target refraction postoperatively, respectively, compared to 28.1 and 46.9% in the manual group, respectively.7 A greater percentage of patients were 0.50 SD in the LenSx Laser group. 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. 2018. Tietokoneohjatulla laserilla tehdn sarveiskalvoviillot, pilkotaan samea linssi ja saadaan tehty tydellinen aukko vanhan linssin poistamista varten (kapsulotomia). hb``g``01G830220 eFWFk|:yv_-VMfa`) w
6 - Opaque Bubble Layer (OBL) 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. 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. Instructions For Use Manual Instructions For Use Manual Instructions For Use Manual. Owners Reviews. HWA7+hIQk' r8q )3=k``U7[MK%_?l
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ysC:We: This device is not intended for use in pediatric surgery. most are cross-trained in multiple specialties, CAS offer assistance with patient application for 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. The FCC chooses 3 or 5 character "Grantee" codes to identify the business that created the product. 2019;60(11):1043-1049. I continue to believe this technology delivers greatly now and even has the potential to deliver more moving forward. Weight: 0.5 lbs: Dimensions: 1 1 1 in: Item Number: LN90040624P. contained in this application pursuant to 47 CFR 0.459 of the Commission Rules? These are not permanent solutions. Alcon's LenSx Laser. endstream
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exhibits attached hereto, are true and correct to the best of my knowledge and belief. Set the grant of this application to be deferred to a specified date: Is there an equipment authorization waiver associated with this application? Smart Clock CD-24501F Manual. Hong Kong It should also be noted that in four of these cases, IOL implantation was still achievable: and two in which sulcus IOL implantation was safely performed in eyes in which the tear extended to the posterior capsule; and two in which in-the-bag implantation was successfully performed in eyes in which the tear extended to the equator without posterior capsule involvement or vitreous loss. 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. Brand: Panasonic | Category: Digital Camera | Size: 5.66 MB. The common alternative used in other laser platforms is a noncontact liquid optical interface. Yesilirmak N, Diakonis VF, Sise A, Waren DP, Yoo SH, Donaldson KE. - I have read and agree to MyAlcon's terms and conditions and privacy policy. Yeu E, et al. Authorizing an agent to sign this application, is done solely at the applicant's discretion; J Cataract Refract Surg. Argentina Intervention: Femtosecond LCS. Spain The LenSx laser uses a curved contact lens which is integrated with a sterile limbal suction ring (SoftFit PI). Show all Leica Laboratory Equipment manuals. Cataract will develop completely & cause further reduction in vision. 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. 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. 2016;100:1201-1205. Kendall Donaldson, MD, MS LenSx user for 4 years Kendall E. Donaldson, MD, MS, is an associate . * Requires VERION Digital Marker L (with LenSx, The Alcon Cataract Refractive Suite allows you to experience complete. A LOI uses a liquid layer between the cornea and optical window of the laser to reduce corneal deformation. 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. Alcon equipment, Made up of tenured ophthalmic technicians Paper presented at: ESCRS; October 7-11, 2017; Lisbon, Portugal. Thanks to its extreme softness it is ideal for cleaning optical and other delicate surfaces. Quick Reference Manual Owner's Manual Owner's Manual. 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 DXX - Part 15 Low Power Communication Device Transmitter. 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. Complicated Cases J&J accused Alcon in 2020 of infringing on 12 of its U.S. patents by selling the LenSx Laser System. Posted: 12/18/2018. Available at: http://www.un.org/en/development/desa/population/ publications/pdf/ageing/WorldPopulationAgeing2013.pdf (accessed September 30, 2015). Singapore. Calculation of axial length using a single group refractive index versus using different refractive indices for each ocular segment. * 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. 142 0 obj
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Value in Health. Colombia SoftFitTM PI uses a soft contact lens insert at the interface to minimize corneal compression. 2016;42:50-61. Mexico Numerous studies have shown reduced endothelial cell loss and reduced postoperative inflammation with LCS.20,34,35, Roberts et al. 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. CAUTION: Federal Law restricts this device to sale and use by or on the order of a physician or licensed eye care practitioner. Weight: 9 lbs: Dimensions: 24 24 24 in: Item Number: hb``a``x
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