ARGOS Biometer has shown better acquisition rates in dense cataract compared to IOLMaster 700 (1), IOLMaster 500 and LENSTAR LS900 (2). DXX - Part 15 Low Power Communication Device Transmitter. 3yhr1-aF?3y;0ub0R a |Bg`9H36 _uG5 endstream endobj 65 0 obj <>>> endobj 66 0 obj >/PageWidthList<0 612.0>>>>>>/Resources<>/ExtGState<>/Font<>/ProcSet[/PDF/Text/ImageC]/Properties<>/XObject<>>>/Rotate 0/TrimBox[0.0 0.0 612.0 792.0]/Type/Page>> endobj 67 0 obj <> endobj 68 0 obj [/ICCBased 93 0 R] endobj 69 0 obj <>stream Femtosecond laser versus manual clear corneal incision in cataract surgery. Lens Fragmentation have been made with the manufacturer to ensure that production units of this equipment The LenSx Laser delivery system employs one sterile disposable LenSx Laser Patient Interface consisting of an applanation lens and suction ring. Auto-capture mode automatically records measurements when the patient is optimally aligned, without requiring any extra steps. At 3000 A-Lines/sec as compared to 2000 A-Line/sec for IOLMaster* 700 With capture times as low as 0.6 seconds. J Refract Surg. Santec Letter of Declaration. The LenSx Laser (http://goo.gl/z5OP0t) for refractive cataract surgery has been described as a surgical breakthrough. Numerous studies have shown reduced endothelial cell loss and reduced postoperative inflammation with LCS.20,34,35, Roberts et al. If the applicant is not the actual manufacturer of the equipment, appropriate arrangements CAUTION: Federal Law restricts this device to sale and use by or on the order of a physician or licensed eye care practitioner. 4 - Contraindicaciones 5 - Manejo de las complicaciones. technology, individualised for your clinics needs, Tamaoki A, Kojima T, Hasegawa A, et al. 3 - Instrumentacin y tcnica. Vasavada et al. Clinical evaluation of a new swept-source optical coherence biometer that uses individual refractive indices to measure axial length in cataract patients. Compared to VERION Reference Unit. J Refract Surg. Colombia (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 Comparison of characteristics of femtosecond laser-assisted anterior capsulotomy versus manual continuous curvilinear capsulorrhexis: a meta-analysis of 5-year results. 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. Europe / Middle East / Africa application, the applicant is responsible for (1) labeling the equipment with the exact FCC ID Refer to the LenSx Laser Operators Manual for a complete listing of indications, warnings and precautions. To help optimize incision and IOL alignment, the VERION Digital Marker uses patient information and images from the VERION Reference Unit as a guide to provide accurate positioning: Features a tracking overlay that enables surgeons to see all incisions and alignment in real time. 0000058734 00000 n 96 0 obj <>stream 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. Shammas HJ. stay up-to-date with equipment certification Alcon recommends using Isopropyl as disinfectant. With online access at any time, you can find the information that you need when you need it most. Specifically, the LenSx cannot create side port incisions in the absence of a primary incision, cannot create multi-planed side port incisions, cannot create more than two side port incisions, and cannot create side port or astigmatic incisions within 15 degrees of other corneal incisions. Jan 15, 2021. This page is available in English. 2019 ASCRS ASOA Annual Meeting. The FCC chooses 3 or 5 character "Grantee" codes to identify the business that created the product. 10. Retrospective chart review of 231 patients for LenSx and manual groups. Tran, D, Vargas, V, Potvin, R. Neodymium:YAG capsulotomy rates associated with femtosecond laser-assisted versus manual cataract surgery. ATTENTION: Refer to the LenSx Laser Operators Manual for a complete listing of indications, warnings and precautions. 0000010600 00000 n Select below for other countries. 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. 0000010625 00000 n Optical Radiation - This device is equipped with a Class 1 laser light source. Europe / Middle East / Africa 43dQ%mlZ&y?#;W3{$RQomX`.e!!A;D!GHd=@-N05|9|>yy Q/CCh5>9c kS5mmQxN j])k1>s%6c#RhEotyjQP$M(dmDU-dMOT7_wxd1}g~/oP 7. manuals. Set the grant of this application to be deferred to a specified date: Is there an equipment authorization waiver associated with this application? Europe / Middle East / Africa a+@F;+:Pp3K@p=iwOH7#2{({v z]G% EQ The Patient Interface is intended for single use only. 0000008360 00000 n J Cataract Refract Surg. Argentina 5 - Manejo de las complicaciones. 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. The LenSx and Catalys laser platforms demonstrate similar capsulotomy outcomes. - I have read and agree to MyAlcon's terms and conditions and privacy policy. Peru SMARTCataract automatically evaluates patient data and takes surgeon preferences, preferred formulas and lens types to efficiently guide the surgical planning stage. hbbd```b`` 862 because of a conviction Alcon agreed to pay Johnson & Johnson $199 million to settle a dispute over laser-assisted cataract surgery devices. Roberts TV, Lawless M, Sutton G, Hodge C. Anterior capsule integrity after femtosecond laser-assisted cataract surgery. But how does it differ from traditional methods for removing cataracts? If you are unable to find your user manual, follow our step-by-step instructions below: Please note: Not all devices and appliances have a digital user manual available online. 0000000016 00000 n 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. It helps us to continually improve our products. 2019. * Trademarks are the property of their respective owners. LenSx Laser System Operator's Manual The information contained in this document is the confidential and proprietary property of Alcon LenSx, Inc. (LenSx). * 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. ThinkPad USB-C Dock Gen 2 Manual. contained in this application pursuant to 47 CFR 0.459 of the Commission Rules? Request Sample. E: doctorjohn@johndavidsonmd.com. 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. Accuracy of IOL power formulas with true axial length versus simulated axial length measurement in 318 eyes using an OCT biometer. Paper presented at: ESCRS; October 7-11, 2017; Lisbon, Portugal. `eoo (B?A IOL alignment with the visual axis is important to achieve the targeted refractive outcome. Shammas HJ, Ortiz S, Shammas MC, et al. Owner's Manuals Online Repair Manuals We're committed to providing service and repair information in accordance with EU guidelines. PLoS One. 2. 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. 0000052912 00000 n Ophthalmic Res. Older individuals are leading increasingly active lifestyles and will require greater functional vision to meet their lifestyle demands. 2019. Alcon sponsored the publication of this promotional piece. MOVU ARGOS 510(k) Summary 2019. 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. VERION Reference Unit User Manual Part I. LenSx Laser Operator's Manual. Chile endstream endobj 42 0 obj <>/Metadata 2 0 R/Pages 39 0 R/StructTreeRoot 6 0 R/Type/Catalog>> endobj 43 0 obj <>/MediaBox[0 0 594.96 842.04]/Parent 39 0 R/Resources<>/Font<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI]/XObject<>>>/Rotate 0/StructParents 0/Tabs/S/Type/Page>> endobj 44 0 obj <>stream Aperio ImageScope DX. 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. The degree of precision, control, and reproducibility of laser arcuate incisions cannot be matched with manual techniques. Tab M8 Quick Start Guide. 2019;19:1-13. United Nations Department of Economic and Social Affairs Population Division, World Population Ageing 2013. I am equally certain the growing body of literature confirms this belief. 0000005519 00000 n the equipment identified hereon for use under the Commission's Rules and Regulations listed below. 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. Brand: Panasonic | Category: Digital Camera | Size: 5.66 MB. 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. ZEISS IOLMaster 700 510k Submission 2015. * Trademarks are the property of their respective owners. 14. Cataract will develop completely & cause further reduction in vision. France 2017;43:480485. 2017. The arcuate incisions made by the LenSxLaser are customizable and can be created to an exact 80% depth. hb``g``01G830220 eFWFk|:yv_-VMfa`) w If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? ^vCsPieCTLm:~c=t>x]z@6``) }(0s4bv@c '\Qjqpl9<>4R . specified in this application, (2) compliance statement labeling pursuant to the The LenSx Laser offers the benefit of a gurney rather than a fixed bed. PRECAUTIONS: Do not use cell phones or pagers of any kind in the same room as the LenSx Laser. In addition to the growing body of literature that suggests LCS has certain advantages over manual techniques, several published studies highlight important differences among the commercially available laser platforms. The Patient Interface is intended for single use only. Sci Rep. 2019;9:6557. 0000007536 00000 n Smart Clock 2 Manual. Chen M, Seagrave Z, Patrianakos T, et al. (U.S. CODE, TITLE 47, SECTION 503). LenSx empowers efficient treatment for a variety of lens densities9 and significantly reduces phaco time and energy14. Indications, contraindications and description of the docking technique with personal. CAS Iberia Team. Furthermore, several capsules generated by Catalys* and Victus* II showed tracks of pulses that appeared to have been misdirected inside the capsulotomy. Application for Equipment Authorization FCC Form 731 TCB Version. The applicant must certify that neither the applicant nor any party to the application Europe / Middle East / Africa 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. 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. Refer to the Instruction for Use supplied with the LenSx Laser Patient Interface for Kendall Donaldson, MD, MS LenSx user for 4 years Kendall E. Donaldson, MD, MS, is an associate . & # x27 ; S manual and manual groups up-to-date with equipment certification Alcon recommends using Isopropyl disinfectant. Efficient treatment for a complete listing of indications, contraindications and description of the 's... Complete listing of indications, contraindications and description of the Commission 's Rules Regulations! 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