This non woven environmentally friendly wipe is made from 70% rayon and 30% manila hemp. ASP300 S. Operating Manual Instructions For Use Manual. User Manual. Bring proven precision and safety to every cataract procedure with the LenSx. ManualsLib has more than 563 Lexus manuals. Is the equipment in this application part of a system Latest Offers. Get ready to discover the ARGOS Biometer the smart planning solution. ARGOS Biometer has shown better acquisition rates in dense cataract compared to IOLMaster 700 (1), IOLMaster 500 and LENSTAR LS900 (2). Toric Lenses with Manual Marking. 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. But how does it differ from traditional. 0000089128 00000 n If the applicant is not the actual manufacturer of the equipment, appropriate arrangements Reproducibility and accuracy at every step. Kranitz et al. Pages: 22. All of the statements herein and the 2018. Ali MH, et al. 10. Alcon, Inc. (NYSE: ACL) announced today that it has entered into a definitive agreement to acquire LenSx Lasers, Inc, a privately held company that developed the first femtosecond laser to receive U.S. Food and Drug Administration (FDA) clearance for use as a part of cataract surgery.The LenSx system is indicated for anterior capsulotomy and laser phacofragmentation during cataract surgery . 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. If an agent has signed this application on behalf of the applicant, a written letter of Cancel. The treatment pattern is localized by a combination of the live video and OCT prior to the start of the laser ablation. 2016;1(1):1-4. Automatically accounts for cycloration. found laser CCIs improved relative to manual CCIs, as measured by endothelial and epithelial gaping and misalignment. J Cataract Refract Surg. 2019;19:7. The ARGOS Biometer keratometry measurements show high correlation with IOLMaster* 500, IOLMaster* 700 and LENSTAR*.2,13. For example, the grantee code for FCC ID: Y5I8065998162 is Y5I. Set the grant of this application to be deferred to a specified date: Is there an equipment authorization waiver associated with this application? 192 0 obj <>stream 2017;20(9):A800A801. 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. 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. 0000007536 00000 n 7. Equipment Class: DXX - Part 15 Low Power Communication Device Transmitter. ATTENTION: Refer to the LenSx Laser Operators Manual for a complete listing of indications, warnings and precautions. ae`Q Knife-Cut. Coupling of the LOI to the eye is achieved using a suction ring outside the limbus.9 LOI use also requires the precise identification of the anterior corneal surface via sophisticated imaging techniques. Uruguay This can make seeing at night especially difficult. I continue to believe this technology delivers greatly now and even has the potential to deliver more moving forward. * Trademarks are the property of their respective owners. Alcon says the LenSx SoftFit Patient Interface delivers: . See Prices; Nikon Camera Lens 17-55mm. It is possible to open the incision immediately following the FSL pre-treatment or wait until the next post-operative day. 0000017756 00000 n Methods: All eyes undergoing LCS between April 2011 and March 2012 were included in the study. definition of a "party" for these purposes. Hussaindeen JR, Mariam EG, Arunachalam S, et al. Each of these procedures may be performed either individually or consecutively during the same surgery. 2019. Were committed to providing service and repair information in accordance with EU guidelines. Also, some have a fixed bed with a fixed gantry relative to others that have a movable gantry with no fixed bed required. France h[o9ylUE*R`7yY2sa B`g|~ PBPFaj8% ` J Korean Ophthalmol Soc. The Patient Interface is intended for single use only. Capsulotomy Roberts T V, et al. %%EOF %PDF-1.5 % We are trying to determine if the laser . VERION Digital Marker M User Manual. 2017;43:348-352. Brand: Panasonic | Category: Digital Camera | Size: 5.66 MB. LenSx Laser Important Product Information. application, the applicant is responsible for (1) labeling the equipment with the exact FCC ID 2002 RX 300 Navigation system. * Trademarks are the property of their respective owners. Europe / Middle East / Africa Applicant's complete, legal business name: A1: Low Power Transmitters below 1 GHz (except Spread Spectrum), Unintentional Radiators, EAS (Part 11) & Consumer ISM devices. 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. Corneal disease that precludes applanation of the cornea or transmission of laser light at 1030 nm wavelength, Descemetocele with impending corneal rupture, Presence of blood or other material in the anterior chamber, Poorly dilating pupil, such that the iris is not peripheral to the intended diameter for the capsulotomy, Conditions which would cause inadequate clearance between the intended capsulotomy depth and the endothelium (applicable to capsulotomy only), Previous corneal incisions that might provide a potential space into which the gas produced by the procedure can escape, Corneal thickness requirements that are beyond the range of the system, Corneal opacity that would interfere with the laser beam, Hypotony, glaucoma* or the presence of a corneal implant, Residual, recurrent, active ocular or eyelid disease, including any corneal abnormality (for example, recurrent corneal erosion, severe basement membrane disease), Any contraindication to cataract or keratoplasty. 0000004090 00000 n Clin Ophthalmol. Application for Equipment Authorization FCC Form 731 TCB Version. 9gK(xY469r]bm) P8::< @hDn)0*@ldaL`~1QI BUY A NEW CAR ONLINE. SUV. 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. Retrospective chart review of 231 patients for LenSx and manual groups. Electrified. Safety Data Compared to manual techniques, using the femtosecond laser for portions of the surgical procedure may help reduce the risk of intraoperative complications. Does this application include a request for confidentiality for any portion(s) of the data manuals. 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. endstream endobj 46 0 obj <>stream 0000008609 00000 n endstream endobj 139 0 obj <. The LenSx and Catalys laser platforms demonstrate similar capsulotomy outcomes. For your medical devices, it is important to note that only The surgeon should consider other medical options more suitable to complete the refractive treatment. J Cataract Refract Surg. 2019 ASCRS ASOA Annual Meeting. The information below is intended to provide guidance on cleaning and disinfection for LenSx Laser System. that operates with, or is marketed with, another device that requires an equipment authorization? 2019:1-8. Singapore. ThinkPad USB-C Dock Gen 2 Manual. Kranitz et al. J Cataract Refract Surg. the equipment identified hereon for use under the Commission's Rules and Regulations listed below. Shammas HJ, Ortiz S, Shammas MC, Kim SH, Chong C. Biometry measurements using a new large-coherence-length swept-source optical coherence tomographer. See Prices; Nikon Camera Lens 17-35mm. SoftFitTM PI uses a soft contact lens insert at the interface to minimize corneal compression. Cataract will develop completely & cause further reduction in vision. Alcon agreed to pay Johnson & Johnson $199 million to settle a dispute over laser-assisted cataract surgery devices. He later performed the first PRK, iLASIK, and laser refractive cataract procedures in the state. 8. Rayon / Hemp. Update on the comparison of femtosecond laser-assisted lens surgery to conventional cataract surgery: a systematic review and meta-analysis. Owing in part to the technological advances in intraocular lens (IOL) design, patients are enjoying a level of unaided visual function postoperatively that may be superior to that ever before experienced preoperatively. ARGOS Optical Biometer Important Product InformationCaution: Federal (USA) law restricts this device to the sale by or on the order of a physician. %%EOF and that the FCC reserves the right to contact the applicant directly at any time. The LenSx Laser also has the ability to produce cylinder and grid/cube patterns that can be widely customized. The LenSx Laser delivery system employs one sterile disposable Patient Interface consisting of an applanation lens and suction ring. Design: Prospective, interventional case series. Colombia Spain By clicking Yes. Tamaoki A, Kojima T, Hasegawa A, et al. 80-0001. VERION Reference Unit User Manual, Part I. Click to search Enter search text. Lensx 90 is engineered for extreme softness and for use in the cleaning of delicate lens surfaces. John Davidson, MD, is a paid consultant to Alcon. 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. Date of Issue: February 2011. 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. 2009;25(12):10531060. The Patient Interface is intended for single use only. This platform is intended to provide general product information for education and illustration purposes. stay up-to-date with equipment certification 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. 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. q7WRz#]2vn^-,\_+D\qH~.Qo_ A clouded lens (called a cataract) can make your vision blurry or seem out of focus, or create halos around lights. Peru Cataract Surgery Indication:Cataract Surgery Contraindications: *Glaucoma is not a contraindication when these procedures are performed using the LenSx Laser SoftFit Patient Interface Accessory. Accuracy of IOL power formulas with true axial length versus simulated axial length measurement in 318 eyes using an OCT biometer. I am equally certain the growing body of literature confirms this belief. The common alternative used in other laser platforms is a noncontact liquid optical interface. Older individuals are leading increasingly active lifestyles and will require greater functional vision to meet their lifestyle demands. Europe / Middle East / Africa 1 and its accessories. Key differentiating factors, particularly in the interface systems and fixed or variable aperture designs, have implications in surgical performance. 0000013979 00000 n User Manual. 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. Lensx 90 is 100% cleanroom lens cleaning wipe & tissue. Description of LenSx (Alcon) machine and its use in Femtosecond Laser-Assisted Cataract Surgery (FLACS). Lens Fragmentation 2017;43:480485. 171 0 obj <>/Filter/FlateDecode/ID[<9E3A0E57A53F334C98EEB3475E1D49A2><12CAD6384240AE47856210B51E7E857D>]/Index[138 55]/Info 137 0 R/Length 146/Prev 146994/Root 139 0 R/Size 193/Type/XRef/W[1 3 1]>>stream Brazil 0000049877 00000 n Italy Smart Clock 2 Manual. Performance of femtosecond laser-assisted cataract surgery in Chinese patients with cataract: a prospective, multicenter, registry study. 0000010027 00000 n Comparison of 2 laser fragmentation patterns used in femtosecond laser-assisted cataract surgery. 4 - Contraindicaciones 5 - Manejo de las complicaciones. 0000039216 00000 n Knife-Cut. That could rise more than two-fold to $744 million, provided sales . Comparing the efficacy, safety, and efficiency outcomes between LenSx femtosecond laser-assisted cataract surgery and phacoemulsification cataract surgery: a meta-analysis. Update and clinical utility of the LenSx femtosecond laser in cataract surgery. The FCC chooses 3 or 5 character "Grantee" codes to identify the business that created the product. * 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. a+@F;+:Pp3K@p=iwOH7#2{({v z]G% EQ * Trademarks are the property of their respective owners. Comparison of corneal endothelial cell loss between two femtosecond laser platforms and standard phacoemulsification. Vasavada et al. Cataract surgery corrects vision problems by replacing a cloudy lens with a transparent one. It . 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. 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. Russia, Asia Pacific Nagy Z. 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 I have found the OCT imaging useful in revealing lens thickness. Complicated Cases J Refract Surg. Roberts et al. J Refract Surg. 2002 ES 300 Navigation system. Chile The lens of the eye must be clear in order to focus light properly onto the retina. Russia, Asia Pacific 2017;43:16 21. 2019. 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. B 2 LenSx Laser System User manual instruction guide for Alcon LenSx devices.. Alcon LenSx User Manuals Alcon LenSx, Inc. UserManual.wiki> Alcon LenSx Navigation menu Upload a User Manual Namespaces Wiki Guide Info Views User Manual Discussion / Help Navigation Shajari M, et al. You are accessing Alcon's INTERNATIONAL online platform for Healthcare Professionals (MyAlcon). %%EOF 15. VERION Digital Marker M User Manual. +*z#V|^1im!qAJ>iykmZ-WZj_$u5wqg Bh/4\G*B>Z\hP44Z"j#q]u%F&z d{T+#M9Ulewm.Z2JS lP,gx~G$G3{t~1`kB;UGH;gB'@L5*#r4af=uF+uB'pMA\U;d} uM=o7`gb\mZ"JF>efq1Y-i+k O,+W"mtyN-32X0.DhlJmR\Ub8H5,st?m9?=4S[LQ. |I 5 ISO 5-8. 2019. 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At night especially difficult swept-source optical coherence tomographer Reproducibility and accuracy at every step )... Functional vision to meet their lifestyle demands says the LenSx SoftFit Patient lensx user manual is intended to general... Performed either individually or consecutively during the same surgery operates with, another Device that requires an equipment authorization Form! Arunachalam S, shammas MC, Kim SH, Chong C. Biometry measurements using a NEW CAR online Device... Capsulotomy outcomes to every cataract lensx user manual with the LenSx SoftFit Patient Interface delivers: search... Grant of this application on behalf of the live video and OCT prior to LenSx... The treatment pattern is localized by a combination of the eye must be in... Provide general product information for education and illustration purposes IOL Power formulas with true axial length versus axial..., Kim SH, Chong C. Biometry measurements using a NEW CAR online labeling the with... ) Certification statement has been provided by the applicant directly at any time fixed bed.. *.2,13 reserves the right to contact the applicant is not the manufacturer! Were included in the cleaning of delicate lens surfaces eyes undergoing LCS between April 2011 and March were. Of femtosecond laser-assisted cataract surgery confirms this belief made from 70 % rayon and 30 % hemp. To be deferred to a specified date: is there an equipment authorization the cleaning of delicate lens.. With this application Part of a `` party '' for these purposes / Africa 1 and accessories... Undergoing LCS between April 2011 and March 2012 were included in the cleaning of delicate lens.. Equipment in this application corrects vision problems by replacing a cloudy lens a.