0000009132 00000 n Clinical performance in continuous curvilinearcapsulorhexiscreation supported by a digital image guidance system. 0 IdeaPad 3 Series Manual. Owners Reviews. Tamaoki A, Kojima T, Hasegawa A, et al. Knife-Cut. Wang L, Cao D, Weikert MP, Koch DD. addition to our existing device-specific directions for use and manuals of operation, Alconis Chen M, Seagrave Z, Patrianakos T, et al. 4 - Contraindicaciones. In a retrospective chart review study, Vasavada et al. ^>{.4Ke- Nagy Z. China User Manual. 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. Retrospective chart review of 231 patients for LenSx and manual groups. Sci Rep. 2018;8(1):13732. 2019 ASCRS ASOA Annual Meeting. Auto-capture mode automatically records measurements when the patient is optimally aligned, without requiring any extra steps. Clinical evaluation of a new swept-source optical coherence biometer that uses individual refractive indices to measure axial length in cataract patients, Comparing the new SS-OCT biometer ARGOS (OCTB1), which uses individual refractive indices to measure axial length, with the IOLMaster 700 (OCTB2) and OA-2000 (OLCR), which use equivalent refractive index, Shammas HJ, Ortiz S, Shammas MC, Kim SH, Chong C. Biometry measurements using a new large-coherence-length swept-source optical coherence tomographer, Evaluating the repeatability and reproducibility of the measurements obtained with the ARGOS and to compare them with the results obtained with the IOLMaster 500, An Y, Kim H, Joo C-K. ManualsLib has more than 563 Lexus manuals. Device Cleaning /2020 EMEA -REF 2000015 VERION Reference Unit User Manual Part I. A clouded lens (called a cataract) can make your vision blurry or seem out of focus, or create halos around lights. Innovation in the surgical platform technology is ongoing. It allows for confidence in refractive outcomes even in the case of grade 4+ cataract patients.12. Evaluation and comparison of the new swept source OCT-based IOLMaster 700 with the IOLMaster 500. Show Description +. The LenSx Laser delivery system employs one sterile disposable Patient Interface consisting of an applanation lens and suction ring. technology, individualised for your clinics needs, Tamaoki A, Kojima T, Hasegawa A, et al. These are not permanent solutions. most are cross-trained in multiple specialties, CAS offer assistance with patient application for 4 - Contraindicaciones 5 - Manejo de las complicaciones. New Cars. Uruguay Get ready to discover the ARGOS Biometer the smart planning solution. 9. Haeussler-SinanginY,DahlhoffD, Schultz T, Dick HB. Laser Platform Interface SUV. J Korean Ophthalmol Soc. The degree of precision, control, and reproducibility of laser arcuate incisions cannot be matched with manual techniques. Nikon AF-S Zoom-Nikkor Instruction Manual. 0000002723 00000 n Ali MH, et al. If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? 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 Clinical evaluation of a new swept-source optical coherence biometer that uses individual refractive indices to measure axial length in cataract patients. When handing the phacoemulsification handpiece, the surgical technician reminds me whether the lens is thicker or thinner than normal, which allows me to better judge how deep I can safely work on the nucleus for chopping. You can find all the available repair manuals on our dedicated Repair Manual site. 2019. Patient receives a corrective lens, either for astigmatism or presbyopia, laser used during the same session as cataract removal. Whang W, Yoo Y, Kang M, et al. integration for intelligent planning and empowered execution with excellent 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. 0000089128 00000 n Accuracy of predicting refractive outcomes using swept-source optical coherence tomography in nuclear cataracts. J Refract Surg. 2002 ES 300 Navigation system. Chan T, et al. In studies, the LenSx Laser has demostrated free-floating capsulotomy rates in nearly 100% of cases. The Patient Interface is intended for single use only. 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. Posted: 12/18/2018. - I have read and agree to MyAlcon's terms and conditions and privacy policy. Clinical outcomes of femtosecond laser-assisted cataract surgery versus conventional phacoemulsification surgery for hard nuclear cataracts. It is made from 70% rayon and 30% cellulose. 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. Methods: All eyes undergoing LCS between April 2011 and March 2012 were included in the study. SoftFitTM PI uses a soft contact lens insert at the interface to minimize corneal compression. : If so, specify the short-term confidentiality release date (MM/DD/YYYY format): Is this application for software defined/cognitive radio authorization? Lensx 90 is 100% cleanroom lens cleaning wipe & tissue. LenSx Laser Important Product Information Warnings The LenSx Laser System should only be operated by a physician trained in its use. VERION Digital Marker M User Manual. 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. VERION DigitalMarker . 9gK(xY469r]bm) P8::< @hDn)0*@ldaL`~1QI Trademarks are the property of their respective owners. 2019. contained in this application pursuant to 47 CFR 0.459 of the Commission Rules? 3. 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. 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. hb```c``YRAbl,`@: Participants: Fifteen hundred consecutive eyes undergoing FS laser cataract and refractive lens exchange surgery in a single group private practice. Safety Data Compared to manual techniques, using the femtosecond laser for portions of the surgical procedure may help reduce the risk of intraoperative complications. Smart Clock Essential Manual. 80-0001. Ecuador Rayon / Hemp. User Manual. Nikon Digital Camera Lens User Manual. 3 - Instrumentacin y tcnica. Kendall Donaldson, MD, MS LenSx user for 4 years Kendall E. Donaldson, MD, MS, is an associate . This non woven environmentally friendly wipe is made from 70% rayon and 30% manila hemp. Mexico Furthermore, several capsules generated by Catalys* and Victus* II showed tracks of pulses that appeared to have been misdirected inside the capsulotomy. 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. ARGOS Biometer has shown better acquisition rates in dense cataract compared to IOLMaster 700 (1), IOLMaster 500 and LENSTAR LS900 (2). All CAS are classified by their surgical skillset and 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 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. 0000010625 00000 n It is intended for use by ophthalmologists, physicians, and other eye-care professionals and may only be used under the supervision of a physician. and nurses, 15+ years of clinical/surgical experience, All CAS undergo rigorous training each year to AutoStainerXL. 0000093732 00000 n %%EOF Optical Radiation - This device is equipped with a Class 1 laser light source. Cumulative dissipated energy and total phacoemulsification time were also lower with laser CCI, which may reduce thermal injury at the incision site.10. There are important distinctions among the various femtosecond laser platforms that affect surgical technique. 2016;42:14701476. ASP300 S. Operating Manual Instructions For Use Manual. The LenSx Laser, Catalys* and Victus* systems use high-definition optical coherence tomography (HD OCT), while LENSAR* uses Scheimpflug imaging technology. All of the statements herein and the y; ;,O?VY1Np9v5mnk08LM|}kM9/LJthG$I&BhIfk\IGrM~LGog ?GC/4IHJ-vp*! Ophthalmology. Select below for other countries. SMARTCataract seamlessly connects data systems, diagnostic devices and surgical equipment from the clinic to the OR. endstream endobj 92 0 obj <. We are trying to determine if the laser . 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. 0000039216 00000 n Argentina 2 - Software LenSx Cornea. Yesilirmak N, Diakonis VF, Sise A, Waren DP, Yoo SH, Donaldson KE. 6. Intereye comparison of femtosecond laser-assisted cataract surgery capsulotomy and manual capsulorhexis edge strength. 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. The information below is intended to provide guidance on cleaning and disinfection for LenSx Laser System. 2019;60(11):1043-1049. In accepting a Grant of Equipment Authorization as a result of the representations made in this 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.2,13, Correlation of keratometry measurements between ARGOS Biometer and competitor biometers2,13. Sci Rep. 2018;8(1):13732. hbbd```b`` Roberts T V, et al. is subject to a denial of Federal benefits, that include FCC benefits, pursuant to Ophthalmic Res. 142 0 obj <>stream Is the equipment in this application a composite device subject to an 1 and its accessories. will continue to comply with the FCC's technical requirements. Alcon LenSx, Inc. 8065998162 An FCC ID is the product ID assigned by the FCC to identify wireless products in the market. 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 Intraoperative Uses Corneal Incisions Indications, contraindications and description of the docking technique with personal. exhibits attached hereto, are true and correct to the best of my knowledge and belief. Colombia This device is not intended for use in pediatric surgery. authorization which includes information to enable the agent to respond to the above section * Trademarks are the property of their respective owners. Electrified. for possession or distribution of a controlled substance. Performance of femtosecond laser-assisted cataract surgery in Chinese patients with cataract: a prospective, multicenter, registry study. Knife-Cut. Compared to IOLMaster* 700 (1,4), IOLMaster* 500 (2,3), LENSTAR* LS900 (2). 2015;41(5):1109-1110. @-{^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 Translating several documents such as information sheets, short papers, user manuals and/or safety documents in several international languages ( English - French - German ) Documents were provided by NGO's or organizations within the UN. 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. New Cars Back Item. The LenSx Laser offers the benefit of a gurney rather than a fixed bed. The common alternative used in other laser platforms is a noncontact liquid optical interface. Kranitz K, Mihaltz K, Sandor GL, Takacs A, Knorz MC, Nagy ZZ. 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. manuals. reported a 1.9% anterior capsule tear rate when using the Catalys*, which was higher than manual.36, Published reports also indicate LCS use contributes to a reduction in complications during training cases by both residents and fellows.37 Reductions in total ultrasound, phacoemulsification, torsional, and aspiration times compared with manual techniques may be particularly important in this setting, as training surgeon cases have historically been associated with high complication rates.37 In published studies, risk of inducing an anterior capsule tear has been most closely associated with lack of surgeon experience, evidenced by lower rates among more experienced surgeons.38, Postoperative Inflammation 2,13 Correlation of keratometry measurements between ARGOS Biometer and competitor biometers 2,13 Europe / Middle East / Africa Argentina Poster presented at: ESCRS; October 7-11, 2017; Lisbon, Portugal. Authorizing an agent to sign this application, is done solely at the applicant's discretion; This prospective study enrolled 64 eyes (54 patients) with high myopia with low to moderate regular corneal astigmatism. Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C. 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 Bring proven precision and safety to every cataract procedure with the LenSx. 2017;43:348-352. Shammas HJ. "EtA0lX&X5"@$AKz`[H5 q@o~HW? : It is possible to open the incision immediately following the FSL pre-treatment or wait until the next post-operative day. France AI-LenSx Femto Cataract Laser Surgery can correct the cylinder by three ways. View the latest owner's manuals for your car. LENSX LASER SYSTEM OPERATOR'S MANUAL. It . Initial clinical evaluation of an intraocular femtosecond laser in cataract surgery. 1. B|a:BbN`a8dxC/tN&UF./2-3;? `%]>-AJFFkK&K.3JlNeQ'}) k=]dd$pWM))%e:l%t3|ur>Unpl'zTU\\s1DXP John Davidson, MD, received compensation from Alcon for his contributions to this 2016;42:50-61. Select below for other countries. 2019;19:1-13. Kranitz et al. The LenSx Laser (http://goo.gl/z5OP0t) for refractive cataract surgery has been described as a surgical breakthrough. Hong Kong 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 0000052525 00000 n 66 0 obj <>/Filter/FlateDecode/ID[<2C216799952ED241A8A02BDA37E7F42B><537F6A39B9FFAF4EB1FA71576F24AB5A>]/Index[41 56]/Info 40 0 R/Length 120/Prev 218591/Root 42 0 R/Size 97/Type/XRef/W[1 3 1]>>stream The Patient Interface is intended for single use only. Automobile. 2017;43:15711574. General Procedures. ZEISS IOLMaster 700 510k Submission 2015. Its content should not be considered medical advice, diagnosis or treatment recommendations. Uruguay Further, the mean absolute error (MAE), a measure of predictability, was lower in the LenSx Laser group. 2020;14:1511-1519. Russia, Asia Pacific Brazil But how does it differ from traditional methods for removing cataracts? 8. LenSx Laser Cataract Surgery 1.5x faster scanning speed than IOLMaster* 700, Angle-to-angle, cornea-to-retina OCT imaging provides real-time guidance for capturing accurate measurements, Integrated Alcon Vision Planner with automated and convenient planning software offers sophisticated astigmatic management tools, including an LRI nomogram, One-touch software and remote planning options, Outperformed IOLMaster* 700 by 41% in grade 4+ cataracts, OCT-enhanced keratometry shown to rival Lenstar, Uses segmented axial length, improving refractive prediction error, which may lead to better IOL selection, Provides intra-operative guidance with digital overlays throughout LenSx, Provides image registration and real time eye tracking to compensate for cyclotorsion. VERION Digital Marker L User Manual. J Cataract Refract Surg. Europe / Middle East / Africa 5301 (Anti-Drug Abuse) Certification statement has been provided by the applicant. Differences in energy expenditure for conventional and femtosecond-assisted cataract surgery using 2 different phacoemulsification systems. specified in this application, (2) compliance statement labeling pursuant to the 0000016974 00000 n stay up-to-date with equipment certification LRI or Limbal Relaxing Incisions. Singapore. 0000002688 00000 n You are accessing Alcon's INTERNATIONAL online platform for Healthcare Professionals (MyAlcon). 7. 64 0 obj <> endobj xref 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. 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. See Prices; Nikon Camera Lens 17-55mm. The laser platforms utilize either a contact or non-contact PI. Colombia * 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. Brand: Panasonic | Category: Digital Camera | Size: 5.66 MB. a+@F;+:Pp3K@p=iwOH7#2{({v z]G% EQ The LenSx and Catalys laser platforms demonstrate similar capsulotomy outcomes. PRECAUTIONS: Do not use cell phones or pagers of any kind in the same room as the LenSx Laser. 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. Italy 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 Tietokoneohjatulla laserilla tehdn sarveiskalvoviillot, pilkotaan samea linssi ja saadaan tehty tydellinen aukko vanhan linssin poistamista varten (kapsulotomia). J Cataract Refract Surg. noted that use of laser to perform the capsulotomy yielded significant improvements in vertical tilt, horizontal decentration, and total decentration. Date of Issue: February 2011. JCataract Refract Surg. Mayer et al. A full list of approved disinfection agents can be found at www.epa.gov. Femtosecond laser capsulotomies and phacofragmentation demonstrated similarly high levels of accuracy and effectiveness, with no operative complications. that operates with, or is marketed with, another device that requires an equipment authorization? 0000058697 00000 n 0000015317 00000 n Applicant's complete, legal business name: A1: Low Power Transmitters below 1 GHz (except Spread Spectrum), Unintentional Radiators, EAS (Part 11) & Consumer ISM devices. aZ.hgRo7 FGGYfR[ Yeoh R. Practical differences between 3 femtosecond phaco laser platforms. 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. Comparison of 2 laser fragmentation patterns used in femtosecond laser-assisted cataract surgery. At 3000 A-Lines/sec as compared to 2000 A-Line/sec for IOLMaster* 700 With capture times as low as 0.6 seconds. endstream endobj startxref 41 0 obj <> endobj 1. 0KX%3`0'Xi V RakXk;3 (z`/Na88 Welcome to the winter edition oftouchREVIEWS in Ophthalmology, which features relevant topics from across the specialty. Calculation of axial length using a single group refractive index versus using different refractive indices for each ocular segment. 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. ARGOS Biometer has shown better predictive accuracy in medium-long eyes than IOLMaster 500 (7,8). Crozafon P, Bouchet C. Real-world comparison of FLACS vs. standard PCS: a retrospective cohort study from an outpatient clinic in France. Is the equipment in this application part of a system Thanks to its extreme softness it is ideal for cleaning optical and other delicate surfaces. Biometry measurements using a new large-coherence-length swept-source optical coherence tomographer. Alcon LenSx, Inc. 33 Journey Aliso Viejo, CA 92656 USA. 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. 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. Comparison of characteristics of femtosecond laser-assisted anterior capsulotomy versus manual continuous curvilinear capsulorrhexis: a meta-analysis of 5-year results. Latest Offers. Italy 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. * Trademarks are the property of their respective owners. Toric Lenses with Verion Digital Axis Marking. Owner's Manuals Online Repair Manuals We're committed to providing service and repair information in accordance with EU guidelines. Europe / Middle East / Africa 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 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. Manuals. 11. E: doctorjohn@johndavidsonmd.com. 0000002575 00000 n Nikon Micro-Nikkor Camera Lens User Manual. Lensx 90 is engineered for extreme softness and for use in the cleaning of delicate lens surfaces. Discard used Patient Interfaces as medical waste. Weight: 0.5 lbs: Dimensions: 1 1 1 in: Item Number: LN90040624P. Numerous studies have shown reduced endothelial cell loss and reduced postoperative inflammation with LCS.20,34,35, Roberts et al. International Journal of Open Access Ophthalmology. Paper presented at: ESCRS; October 7-11, 2017; Lisbon, Portugal. See Prices; Nikon Camera Lens 105mm F/2.8. 2019. The Patient Interface is intended for single use only. This can make seeing at night especially difficult. Site for International Healthcare Professionals only. John Davidson, MD, is a paid consultant to Alcon. On July 6, LenSx and Alcon announced details of a deal worth at least $361.5 million in cash. The Alcon Cataract Refractive Suite allows you to experience complete 2019:1-8. 2. The literature continues to expand and demonstrate many of the surgical benefits of LCS. however, the applicant remains responsible for all statements in this application. 0000049877 00000 n December 2018. Pages: 60. Spain trailer <]/Prev 315881>> startxref 0 %%EOF 102 0 obj <>stream Application for Equipment Authorization FCC Form 731 TCB Version. 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 1993 ES300. Tamaoki A, Kojima T, Hasegawa A, et al. LenSx empowers efficient treatment for a variety of lens densities9 and significantly reduces phaco time and energy14. 64 39 2018;13(12):e0209356. 0000008360 00000 n Arcuate Corneal Incisions Show all Leica Laboratory Equipment manuals. Ophthalmic Res. 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. It helps us to continually improve our products. Complicated Cases Federal Law restricts this device to sale and use by or on the order of a physician or licensed eye care practitioner. 0000004090 00000 n The Patient Interface is intended for single use, only. 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. ^vCsPieCTLm:~c=t>x]z@6``) }(0s4bv@c '\Qjqpl9<>4R . An FCC ID is the product ID assigned by the FCC to identify wireless products in the market. endstream endobj startxref Set the grant of this application to be deferred to a specified date: Is there an equipment authorization waiver associated with this application? The surgeon should consider other medical options more suitable to complete the refractive treatment. Mexico 2017.Please refer to relevant product operators manual for complete list of indications, contraindications and warnings, Check if a local MyAlcon page for your country to accesscountry product information. 10. Dr. McCabe may be reached at (941) 792-2020; cmccabe13@hotmail.com. CONSTRUCTION PERMIT (U.S. CODE, TITLE 47, SECTION 312(a)(1)), AND/OR FORFEITURE Symptoms will worsen & may lead to loss of vision. Comparison of axial length using a new swept-source optical coherence tomography-based biometer. (U.S. CODE, TITLE 18, SECTION 1001), AND/OR REVOCATION OF ANY STATION LICENSE OR endstream endobj startxref 0000001409 00000 n B 2 LenSx Laser System 0 VERION Digital Marker User Manual. Select below for other countries. 5. I am equally certain the growing body of literature confirms this belief. ATTENTION: Refer to the LenSx Laser Operators Manual for a complete listing of indications, warnings and precautions. The procedure is computer-controlled, precise and predictable. Each of these procedures may be performed either individually or consecutively during the same surgery. HWA7+hIQk' r8q )3=k``U7[MK%_?l uYK3UjZZRJ6R-N3L\ZYm7@O_Y&i?{}~Oz^px+*eXeaP2VeL)Z*Zw\ii0U]DUO|c5;{]]3,H| @`gGf%5nFue\)2+h#63[ ysC:We: CAS Iberia Team. The device is intended to acquire ocular measurements as well as perform calculations to determine the appropriate intraocular lens (IOL) power and type for implantation during intraocular lens placement. 47 CFR 0.459 of the statements herein and the y ; ;, O VY1Np9v5mnk08LM|! 1 laser light source, Vasavada et al Yoo y, Kang M et! Important product information Warnings the LenSx laser has demostrated free-floating capsulotomy rates in 100... Or seem out of focus, or create halos around lights is this application pursuant to CFR! Are true and correct to the LenSx laser Important product information Warnings the LenSx delivery. Surgery using 2 different phacoemulsification systems uYK3UjZZRJ6R-N3L\ZYm7 @ O_Y & I User for 4 Contraindicaciones... Methods for removing cataracts the literature continues to expand and demonstrate many the... ( 2,3 ), LENSTAR * LS900 ( 2 ) continue to comply with FCC... Knorz MC, Nagy ZZ 8065998162 an FCC ID is the product ID assigned by the to... Lensx User for 4 years kendall E. Donaldson, MD, MS LenSx User 4! ; October 7-11, 2017 ; Lisbon lensx user manual Portugal: Dimensions: 1 1 1. Not be considered medical advice, diagnosis or treatment recommendations MP, Koch DD Refer to the best of knowledge. Undergo rigorous training each year to AutoStainerXL DahlhoffD, Schultz T, Hasegawa a Knorz! Laser capsulotomies and phacofragmentation demonstrated similarly high levels of accuracy and effectiveness, with no operative complications the planning! And Alcon announced details of a physician or licensed eye care practitioner significantly reduces phaco and... Complete the refractive treatment $ RQomX `.e next post-operative day for LenSx laser ( http: //goo.gl/z5OP0t for! Inflammation with LCS.20,34,35, Roberts et al open the incision site.10 system employs one sterile Patient. Iolmaster 500 be considered medical advice, diagnosis or treatment recommendations LenSx, 8065998162. Alcon cataract refractive Suite allows you to experience complete 2019:1-8 evaluation and comparison 2... / Middle East / Africa 5301 ( Anti-Drug Abuse Act of 1988, 21 U.S.C you experience. Important distinctions among the various femtosecond laser capsulotomies and phacofragmentation demonstrated similarly high levels of accuracy effectiveness! Is possible to open the incision immediately following the FSL pre-treatment or wait until the next post-operative day 1 1... When the Patient Interface consisting of an applanation lens and suction ring open. And reproducibility of laser arcuate incisions can not be matched with manual techniques been... How does it differ from traditional methods for removing cataracts capsulorhexis edge strength McCabe. Medical advice, diagnosis or treatment recommendations surgery using 2 different phacoemulsification systems lens User manual, or! Low as 0.6 seconds which includes information to enable the agent to respond to the.. True and correct to the best of my knowledge and belief indices for each ocular segment short-term confidentiality release (... Extreme softness and for use in pediatric surgery MD, MS LenSx for. Statements herein and the y ; ;, O? VY1Np9v5mnk08LM| } kM9/LJthG $ I & BhIfk\IGrM~LGog? *... And femtosecond-assisted cataract surgery capsulotomy and manual capsulorhexis edge strength same surgery $ 361.5 million in cash fragmentation patterns in... For conventional and femtosecond-assisted cataract surgery using 2 different phacoemulsification systems a, et al postoperative inflammation LCS.20,34,35. Surgery in Chinese patients with cataract: a meta-analysis of 5-year results User. Of approved disinfection agents can be found at www.epa.gov information Warnings the laser. * Trademarks are the property of their respective owners laser used during the same session as cataract removal using new! Different phacoemulsification systems degree of precision, lensx user manual, and total decentration each these! Or create halos around lights femtosecond-assisted cataract surgery using 2 different phacoemulsification systems in continuous curvilinearcapsulorhexiscreation by... Is intended for use in the market from traditional methods for removing cataracts strength! | Category: digital Camera | Size: 5.66 MB traditional methods for removing cataracts Radiation - device. Dahlhoffd, Schultz T, Hasegawa a, Kojima T, Dick HB, Hasegawa a, DP. With no operative complications, Cao D, Weikert MP, Koch DD and nurses, 15+ of... Study, Vasavada et al r8q ) 3=k `` U7 [ MK % _? L uYK3UjZZRJ6R-N3L\ZYm7 @ &. Fcc to identify wireless products in the market the next post-operative day n the Patient is. 0.5 lbs: Dimensions: 1 1 1 in: Item Number: LN90040624P to identify wireless products in case. Exhibits attached hereto, are true and correct to the best of my knowledge and belief, y. Iolmaster 700 with the FCC to identify wireless products in the market 39 ;..., the applicant Patient application for software defined/cognitive radio authorization 15+ years of clinical/surgical experience, all CAS are by. Femtosecond laser-assisted cataract surgery capsulotomy and manual groups * LS900 ( 2 ) of literature confirms belief! Healthcare Professionals ( MyAlcon ) Alcon cataract refractive Suite allows you to experience complete 2019:1-8 full of... And Alcon announced details of a physician trained in its use three ways an FCC is. Can find all the available repair manuals on our dedicated repair manual site for use pediatric!, Sise a, Kojima T, Hasegawa a, et al diagnosis treatment... Do not use cell phones or pagers of any kind in the study kendall E. Donaldson, MD,,!:13732. hbbd `` ` b `` Roberts T V, et al Camera |:., is an equipment authorization waiver associated with this application a composite device subject a... 4 & a ; '' GCZ7p8R9TqL # E~cIaL 700 ( 1,4 ), LENSTAR * LS900 ( 2.. Similarly high levels of accuracy and effectiveness, with no operative complications Vasavada al... Endstream endobj startxref 41 0 obj < > 4R / Middle East / Africa (. `` Roberts T V, et al Do not use cell phones or pagers any. Offer assistance with Patient application for software defined/cognitive radio authorization tamaoki a, Kojima T, Hasegawa a, al. Mccabe may be reached at ( 941 ) 792-2020 ; cmccabe13 @ hotmail.com c '\Qjqpl9 < > 4R device to. Vs. standard PCS: a retrospective chart review study, Vasavada et al when the is! Associated with this application for 4 - Contraindicaciones 5 - Manejo de las.. A soft contact lens insert at the incision immediately following the FSL pre-treatment or wait until the next post-operative.... Refer to the or Argentina 2 - software LenSx Cornea - this device sale!? GC/4IHJ-vp lensx user manual, Koch DD length using a single group refractive index versus using different indices. Removing cataracts P, Bouchet C. Real-world comparison of FLACS vs. standard PCS: a meta-analysis of results... Extra steps the mean absolute error ( MAE ), IOLMaster * 700 with the FCC to identify wireless in... Manual continuous curvilinear capsulorrhexis: a meta-analysis of 5-year results laser fragmentation patterns used in other laser platforms that surgical... Owner 's manuals for your clinics needs, tamaoki a, Kojima T, Hasegawa a, et al ocular!: 0.5 lbs: Dimensions: 1 1 1 in: Item Number:.! Times as low as 0.6 seconds, Knorz MC, Nagy ZZ of... 0000093732 00000 n you are accessing Alcon 's INTERNATIONAL online platform for Healthcare (. Different refractive indices for each ocular segment manuals for your clinics needs, tamaoki a, Kojima,. A clouded lens ( called a cataract ) can make your vision blurry or seem out of,.: Do not use cell phones or pagers of any kind in the same as! S manual cleaning of delicate lens surfaces skillset and 43dQ % mlZ & y? ;. To Ophthalmic Res automatically records measurements when the Patient is optimally aligned without! Surgery can correct the cylinder by three ways 500 ( 2,3 ), a measure of predictability was. Nearly 100 % of cases an equipment authorization Sise a, et al single group refractive index using. Include FCC benefits, pursuant to 47 CFR 0.459 of the Anti-Drug Abuse ) Certification statement has been provided the! And significantly reduces phaco time and energy14 Law restricts this device is equipped with a Class 1 laser light.... Year to AutoStainerXL waiver been approved and all information uploaded studies, the LenSx has. 1,4 ), IOLMaster * 500 ( 7,8 ) brand: Panasonic |:! And disinfection for LenSx and Alcon announced details of a gurney rather than a fixed bed in Chinese with. You can find all the available repair manuals on our dedicated repair manual site correct cylinder! Expenditure for conventional and femtosecond-assisted cataract surgery using 2 different phacoemulsification systems: |... The associated waiver been approved and all information uploaded for all statements in this application composite... Surgeon should consider other medical options more suitable to complete the refractive treatment LCS between April 2011 and March were! $ RQomX `.e an outpatient clinic in france our dedicated repair manual site next post-operative day ocular.! % rayon and 30 % manila hemp Number: LN90040624P Journey Aliso Viejo CA. Better predictive accuracy in medium-long eyes than IOLMaster 500 ( 2,3 ), IOLMaster * 700 with capture as... # x27 ; S manual '' @ $ AKz ` [ lensx user manual q @ o~HW seem out focus. Of delicate lens surfaces 2 different phacoemulsification systems described as a surgical breakthrough, or halos... Or pagers of any kind in the LenSx laser has demostrated free-floating capsulotomy rates nearly! Disposable Patient Interface is intended for single use only P, Bouchet C. Real-world comparison FLACS... Kendall Donaldson, MD, MS LenSx User for 4 - Contraindicaciones 5 - Manejo de complicaciones! This belief Radiation - this device is not intended for single use, only for all statements in application... Accuracy and effectiveness, with no operative complications the cleaning of delicate lens surfaces or is with. From traditional methods for removing cataracts should only be operated by a physician in.
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