Spain Mexico View the latest owner's manuals for your car. 2017;33(10):708712. All material is provided on the understanding that users are competent in the selected discipline, and follow all legislative and environmental regulations. stay up-to-date with equipment certification 0000089128 00000 n Rayon / Hemp. VERION Reference Unit User Manual Part I. Hong Kong The surgical correction of astigmatism is challenging. VERION Digital Marker for LenSx and Microscope Unplug the main power cable from the power supply prior to cleaning. 1 and its accessories. Mexico Ecuador With online access at any time, you can find the information that you need when you need it most. J Pak Med Assoc. exhibits attached hereto, are true and correct to the best of my knowledge and belief. Cumulative dissipated energy and total phacoemulsification time were also lower with laser CCI, which may reduce thermal injury at the incision site.10. The Catalys* and LENSAR* feature a non-contact liquid optical interface (LOI), the Victus* has a curved PI that is non-contact during the capsulotomy and fragmentation portions of the surgery but contact for corneal work, and the LenSx Laser uses a SoftFitTM PI, a curved hydrogel contact lens interface (CCL) first introduced in 2012. 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. 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. 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. Show all featured manuals. This edition contains a wide range of articles evaluating current practice and research, as well as innovations that directly affect ophthalmologists. PLOS ONE. 2020;14:1511-1519. An FCC ID is the product ID assigned by the FCC to identify wireless products in the market. 0KX%3`0'Xi V RakXk;3 (z`/Na88 Santec Letter of Declaration. The LenSx and Catalys laser platforms demonstrate similar capsulotomy outcomes. %PDF-1.5 % Dr. McCabe may be reached at (941) 792-2020; cmccabe13@hotmail.com. Tietokoneohjatulla laserilla tehdn sarveiskalvoviillot, pilkotaan samea linssi ja saadaan tehty tydellinen aukko vanhan linssin poistamista varten (kapsulotomia). UX Available to buy online HYBRID SUV . B 2 LenSx Laser System The growing body of evidence on the use of LCS is consistently showing certain advantages over manual techniques, while noting differences among the platforms.6,7,13,18,19,32,36,41 Reported complication rates are low and may be platform-related rather than category-dependent. Methods: All eyes undergoing LCS between April 2011 and March 2012 were included in the study. Comparison of axial length using a new swept-source optical coherence tomography-based biometer. LenSx Laser Important Product Information. 2,13 Correlation of keratometry measurements between ARGOS Biometer and competitor biometers 2,13 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. ATTENTION: Refer to the ARGOS User Manual for a complete description of proper use and maintenance, optical and technical specifications, as well as a complete list of warnings and precautions. Innovation in the surgical platform technology is ongoing. The interface gently makes contact rather than first fitting a suction ring directly onto the patients eye followed by docking the patient up to the laser objective head.40, Some platforms possess a fixed bed, which can help stabilize the head during image capture and treatment, but brings with it the necessity of moving a patient to another bed for the remainder of the surgery.19. VERION DigitalMarker . This non woven environmentally friendly wipe is made from 70% rayon and 30% manila hemp. 2016;42:50-61. 2018. 2012;28(4):259263. 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. 8jNT4Ok{iMBCT),XUsU`lRouQ]ZIZr+W9aCfN:a!Wp||t5N&Sa V|{OiFM#;cRImrUZ}"P. &GCt"rH!kjAlO (`Bj`fHu*])5ED1*{jW1jr2/9*pv_NZ$wQDue_6 x2 If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? Cancel. Paper presented at: ASCRS; May 5-9, 2017; Los Angeles, CA. 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. The FCC chooses 3 or 5 character "Grantee" codes to identify the business that created the product. This prospective study enrolled 64 eyes (54 patients) with high myopia with low to moderate regular corneal astigmatism. Sci Rep. 2018;8(1):13732. Hong Kong LenSx Laser Important Product Information Warnings The LenSx Laser System should only be operated by a physician trained in its use. You are accessing Alcon's INTERNATIONAL online platform for Healthcare Professionals (MyAlcon). a+@F;+:Pp3K@p=iwOH7#2{({v z]G% EQ 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 2019 ASCRS ASOA Annual Meeting. J&J subsequently expanded the case to cover copyright infringement claims and began a parallel challenge to Alcon in Europe. Alcon equipment, Made up of tenured ophthalmic technicians Show all Leica Laboratory Equipment manuals. manuals. A Pilot Study To Compare Using VERIONImaging Guided System (Alcon) To Manual Marking In Assisting LRI (Limbal RelaxationIncision) To ReduceCylinder Power In Cataract Surgery. The LenSx Laser, Catalys* and Victus* systems use high-definition optical coherence tomography (HD OCT), while LENSAR* uses Scheimpflug imaging technology. User Manual. Alcon LenSx, Inc. 33 Journey Aliso Viejo, CA 92656 USA. ARGOS Biometer User Manual. Go - USB-C Wireless Mouse Manual. SMARTCataract seamlessly connects data systems, diagnostic devices and surgical equipment from the clinic to the OR. It is not intended to provide information to the general public or medical advice. The LenSx Laser (http://goo.gl/z5OP0t) for refractive cataract surgery has been described as a surgical breakthrough. I confirm that: endstream endobj 45 0 obj <>stream Select below for other countries. additional equipment authorization? Shajari M, et al. "H Djd3X$v H(q In 1996, Dr. Solomon performed the first LASIK procedure in South Carolina. The LenSx Laser System should only be operated by a physician trained in its use. Europe / Middle East / Africa Is the equipment in this application a composite device subject to an J Cataract Refract Surg. May 2018 in COMPLIANCE. For example, the grantee code for FCC ID: Y5I8065998162 is Y5I. VERION Reference Unit User Manual Part II. To evaluate the safety, efficacy, and predictability of implantable collamer lens (ICL) implantation combined with a LenSx femtosecond laser-assisted limbal relaxing incision (LRI) for the correction of corneal astigmatism. The applicant must certify that neither the applicant nor any party to the application The PI design is a critical differentiating factor in the various platforms. Cataract surgery corrects vision problems by replacing a cloudy lens with a transparent one. Ali MH, et al. Alcon Data on File 2019, report # SD-18-0001-670-01. <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. Device Cleaning /2020 EMEA -REF 2000015 hb``g``01G830220 eFWFk|:yv_-VMfa`) w 6 - Opaque Bubble Layer (OBL) Predictive accuracy of partial coherence interferometry and swept-source optical coherence tomography for intraocular lens power calculation. Description of product as it is marketed: that operates with, or is marketed with, another device that requires an equipment authorization? endstream endobj 139 0 obj <. 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. 0000093732 00000 n 0 aZ.hgRo7 FGGYfR[ Date of Issue: February 2011. 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 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). 1. 0 Performance of femtosecond laser-assisted cataract surgery in Chinese patients with cataract: a prospective, multicenter, registry study. 2017;43:16 21. Knife-Cut. 0000010027 00000 n 0000007536 00000 n 0000049877 00000 n Kohnen T, Mathys L, Petermann K, et al. Owners Reviews. If the applicant is not the actual manufacturer of the equipment, appropriate arrangements Uruguay ATTENTION: Refer to the LenSx Laser Operators Manual for a complete listing of indications, warnings and precautions. Bring proven precision and safety to every cataract procedure with the LenSx. The LenSx Laser (http://goo.gl/z5OP0t) for refractive cataract surgery has been described as a surgical breakthrough. Use of disposables other than those manufactured by Alcon may affect system performance and create potential hazards. J Cataract Refract Surg. 2016;11(3):e0152088. Methods . 1. Weight: 0.5 lbs: Dimensions: 1 1 1 in: Item Number: LN90040624P. Use a solution containing at least 70% Isopropyl alcohol, as recommended by the CDC. A retrospective comparison of clinical outcomes associated with manual and femtosecond laser cataract surgery. These letters are chosen by the applicant. Smart Clock Essential Manual. Capsulotomy integration for intelligent planning and empowered execution with excellent User manual instruction guide for LenSx Laser 8065998162 Alcon LenSx, Inc.. UiqFc XLZN! Federal Law restricts this device to sale and use by or on the order of a physician or licensed eye care practitioner. Image Guided Integration from the clinic to the OR designed to increase precision and enhance data integrity. J Refract Surg. 0000008498 00000 n The surgeon should consider other medical options more suitable to complete the refractive treatment. endstream endobj startxref precision at every step. LenSx Laser Cataract Surgery I continue to believe this technology delivers greatly now and even has the potential to deliver more moving forward. 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. * Trademarks are the property of their respective owners. Russia, Asia Pacific 4&a;"GCZ7p8R9TqL#E~cIaL!{6SQv77]\E uvbTZ *fb'=+(a&cn0.aw29I]YU"T,r%N^>~HWw0\+_-V&VksWYs@e =AwC;=O5iDaOx@yhdld|3N=ap08v-3Zo48z\ mio For your medical devices, it is important to note that only 0000008360 00000 n 2017;43:15711574. Compared to IOLMaster* 700 (1,4), IOLMaster* 500 (2,3), LENSTAR* LS900 (2). Discard used Patient Interfaces as medical waste. LenSx Laser Operator's Manual. 0000001076 00000 n Weight: 9 lbs: Dimensions: 24 24 24 in: Item Number: Quick Reference Manual Owner's Manual Owner's Manual. hb``g``: $,P#0p4 C1C( c/$zLuX1~b`pCQOx3i'Oxk>gX-LA30p Participants: Fifteen hundred consecutive eyes undergoing FS laser cataract and refractive lens exchange surgery in a single group private practice. Welcome to the winter edition oftouchREVIEWS in Ophthalmology, which features relevant topics from across the specialty. Compared to VERION Reference Unit. 2019;19:1-13. B|a:BbN`a8dxC/tN&UF./2-3;? `%]>-AJFFkK&K.3JlNeQ'}) k=]dd$pWM))%e:l%t3|ur>Unpl'zTU\\s1DXP 0000008100 00000 n hbbd```b``"+ &[A$>/z;Tz6AD*K&&1`:TdA@l/ R720$1L 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. The common alternative used in other laser platforms is a noncontact liquid optical interface. 2017;43:348-352. The treatment pattern is localized by a combination of the live video and OCT prior to the start of the laser ablation. : Does short-term confidentiality apply to this application? 0000004090 00000 n IOL alignment with the visual axis is important to achieve the targeted refractive outcome. Electrified. 5301 (Anti-Drug Abuse) Certification statement has been provided by the applicant. In studies, the LenSx Laser has demostrated free-floating capsulotomy rates in nearly 100% of cases. hb```c``YRAbl,`@: Retrospective chart review of 231 patients for LenSx and manual groups. But how does it differ from traditional methods for removing cataracts? While it's often marketed as "laser cataract surgery," this is an oversimplification of both the device and the surgeon's role in surgery. 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. Al-Mohtaseb Z, et al. This review consolidates, organizes, and summarizes key published literature on the LenSx Laser. 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. Alcon lensx user manual pdf 1 LENSX LASER SYSTEM OPERATOR S MANUAL Alcon LenSx, Inc. 33 Journey Aliso Viejo, CA USA Date of Issue: February 2011 Distrubuted By: Alcon Laboratories, Inc South Freeway Fort Worth, TX USA Alcon Laboratories, UK Ltd. Pentagon Park, Boundary Way Hemel Hempstead Hertfordshire, HP2 7UD, UK Rev. Site for International Healthcare Professionals only. Chile Colombia 862 because of a conviction 2017. Peru Roberts TV, Lawless M, Sutton G, Hodge C. Anterior capsule integrity after femtosecond laser-assisted cataract surgery. Set the grant of this application to be deferred to a specified date: Is there an equipment authorization waiver associated with this application? Spain Kranitz K, Mihaltz K, Sandor GL, Takacs A, Knorz MC, Nagy ZZ. The Patient Interface is intended for single use only. publication. Indications: ARGOS is a non-invasive, non-contact biometer based on swept-source optical coherence tomography (SS-OCT). endstream endobj 92 0 obj <. 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. Initial clinical evaluation of an intraocular femtosecond laser in cataract surgery. The arcuate incisions made by the LenSxLaser are customizable and can be created to an exact 80% depth. J Refract Surg. The ARGOS Biometer and integrated Alcon Vision Planner makes the process of surgery planning and IOL power calculation easier. Singapore. Italy Comparison of axial length using a new swept-source optical coherence tomography-based biometer. 2002 ES 300 Navigation system. 0000005519 00000 n This page is available in English. We are trying to determine if the laser . Applicant's complete, legal business name: A1: Low Power Transmitters below 1 GHz (except Spread Spectrum), Unintentional Radiators, EAS (Part 11) & Consumer ISM devices. It helps us to continually improve our products. VERION Digital Marker. Pages: 22. MOVU ARGOS 510(k) Summary 2019. 8. J Cataract Refract Surg. 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 ARGOS Biometer utilises SS-OCT-enhanced keratometry with angle-to-angle, cornea-to-retina, real-time OCT guidance, allowing the user to monitor patient alignment and fixation and helping acquisition of accurate measurements every time. 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. Ophthalmic Res. VERION Digital Marker L User Manual. 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. IdeaPad 3 Series Manual. J Cataract Refract Surg. Numerous studies have shown reduced endothelial cell loss and reduced postoperative inflammation with LCS.20,34,35, Roberts et al. Rayon / Hemp. 2017;67(10):1574 1579. 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. 142 0 obj <>stream 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. CAS Iberia Team. Alcon LenSx User Manuals User manual instruction guides for Alcon LenSx devices. Cataract Surgery Indication:Cataract Surgery Contraindications: *Glaucoma is not a contraindication when these procedures are performed using the LenSx Laser SoftFit Patient Interface Accessory. 0000002723 00000 n Clin Ophthalmol. The lens of the eye must be clear in order to focus light properly onto the retina. reported significantly worse corrected distance visual acuity at one month in eyes operated with manual versus laser techniques, which they attributed to the possible inducement of higher-order aberrations secondary to lens tilt in the manual group that could not be corrected with spectacles.13 The authors noted 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. 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Prospective study enrolled 64 eyes ( 54 patients ) with high myopia with low to moderate regular corneal.... User manual instruction guides for Alcon LenSx, Inc. 33 Journey Aliso Viejo, CA 92656 USA single. Traditional methods for removing cataracts guides for Alcon LenSx devices 2018 ; 8 ( 1 ):13732 cloudy with! Select below for other countries linssin poistamista varten ( kapsulotomia ) that directly affect.... Performance of femtosecond laser-assisted cataract surgery has been provided by the FCC to identify products. And follow all legislative and environmental regulations Kong LenSx Laser ( http: //goo.gl/z5OP0t for. Achieve the targeted refractive outcome and femtosecond Laser cataract surgery has been described as a surgical.! Planning and IOL power calculation easier in Chinese patients with cataract: a prospective, multicenter, study... Welcome to the or designed to increase precision and safety to every cataract with... A ; '' GCZ7p8R9TqL # E~cIaL LENSTAR * LS900 ( 2 ) J cataract Refract Surg Laser cataract. On File 2019, report # SD-18-0001-670-01 are customizable and can be created to J... And Catalys Laser platforms demonstrate similar capsulotomy outcomes to the or Trademarks are the property their., LENSTAR * LS900 ( 2 ) thermal injury at the incision site.10 only be operated a... Capsulotomy rates in nearly 100 % of cases Date: is there an equipment authorization J subsequently expanded the to!
