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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. 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. Clinical evaluation of a new swept-source optical coherence biometer that uses individual refractive indices to measure axial length in cataract patients. "An Evaluation of the Femto Second LenSx assisted Cataract Surgeries compared to normal . J Cataract Refract Surg. Russia, Asia Pacific ChristieCleaning Projector Optics.pdf,Technical Bulletin Cleaning projector optics This document provides information and procedures for cleaning optical components in the Christie cinema projectors identified in the products list. 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. Al-Mohtaseb Z, et al. 2019;19:1-13. Ecuador A Pilot Study To Compare Using VERIONImaging Guided System (Alcon) To Manual Marking In Assisting LRI (Limbal RelaxationIncision) To ReduceCylinder Power In Cataract Surgery. VERION Digital Marker User Manual. 2 - Software LenSx Cornea. The ARGOS Biometer is faster than other market-leading biometers.1-5 With a biometric data capture time of less than1second and a higher scanning speed, 50% faster than IOLMaster* 700, the ARGOS Biometer allows for enhanced efficiency and accuracy of eye measurements.1,9. The content has been independently peer reviewed and verified by the US Ophthalmic Review publication process. Shajari M, et al. The FCC chooses 3 or 5 character "Grantee" codes to identify the business that created the product. Chan T, et al. 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. endstream endobj 46 0 obj <>stream * Retrospective chart review of 225 patients for LenSx and manual groups. 0000007536 00000 n Omoto MK, Torii H, Masui S, Ayaki M, Tsubota K, Negishi K. Ocular biometry and refractive outcomes using two swept-source optical coherence tomography-based biometers with segmental or equivalent refractive indices. * Trademarks are the property of their respective owners. 1 and its accessories. All material is provided on the understanding that users are competent in the selected discipline, and follow all legislative and environmental regulations. Europe / Middle East / Africa Spain United Kingdom - English, Americas 6. J Cataract Refract Surg. Comparison of corneal endothelial cell loss between two femtosecond laser platforms and standard phacoemulsification. It helps us to continually improve our products. In 1996, Dr. Solomon performed the first LASIK procedure in South Carolina. Its worth noting, there is a charge for some hard copy content and subscription services. Alcon agreed to pay Johnson & Johnson $199 million to settle a dispute over laser-assisted cataract surgery devices. LenSx Crnea. 2020;14:1511-1519. Uruguay If an agent has signed this application on behalf of the applicant, a written letter of Patient receives a corrective lens, either for astigmatism or presbyopia, laser used during the same session as cataract removal. 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. Laser Platform Interface Cataract surgery benefits patients beyond improved vision, including a decrease in falls and improvements in general physical, cognitive, and emotional wellbeing.3, In the US, femtosecond laser technology during cataract surgery is approved to create corneal incisions, perform the capsulotomy, and fragment the lens.4,5 LCS has gained acceptance largely due to its perceived benefits compared to manual techniques: greater precision in the surgical steps and increased consistency. Please consider the guidance provided in Table 1 when you encounter these factors. In a retrospective chart review study, Vasavada et al. France Paper presented at: ASCRS; May 5-9, 2017; Los Angeles, CA. 2009;25(12):10531060. A LOI uses a liquid layer between the cornea and optical window of the laser to reduce corneal deformation. Sci Rep. 2018;8(1):13732. While it's often marketed as "laser cataract surgery," this is an oversimplification of both the device and the surgeon's role in surgery. Future Directions is subject to a denial of Federal benefits, that include FCC benefits, pursuant to ^vCsPieCTLm:~c=t>x]z@6``) }(0s4bv@c '\Qjqpl9<>4R . the equipment identified hereon for use under the Commission's Rules and Regulations listed below. Latest Offers. Hussaindeen JR, Mariam EG, Arunachalam S, et al. 2019;19:1-13. `eoo (B?A CONTRAINDICATIONSCataract Surgery Contraindications 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) History of lens or zonular instability Any contraindication to cataract or keratoplasty This device is not intended for use in pediatric surgery. noted that use of laser to perform the capsulotomy yielded significant improvements in vertical tilt, horizontal decentration, and total decentration. I have found the OCT imaging useful in revealing lens thickness. * Trademarks are the property of their respective owners. Key differentiating factors, particularly in the interface systems and fixed or variable aperture designs, have implications in surgical performance. Poster presented at: ESCRS; October 7-11, 2017; Lisbon, Portugal. Image Guided Integration from the clinic to the OR designed to increase precision and enhance data integrity. ARGOS Optical Biometer Important Product InformationCaution: Federal (USA) law restricts this device to the sale by or on the order of a physician. 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. LenSx Laser Important Product Information Warnings The LenSx Laser System should only be operated by a physician trained in its use. VERION Digital Marker L User Manual. Update and clinical utility of the LenSx femtosecond laser in cataract surgery. Integration with the Digital Marker Microscope (DMM) helps you execute your patients surgical plan with digital accuracy. LENSX LASER SYSTEM OPERATOR'S MANUAL. For your medical devices, it is important to note that only China Site for International Healthcare Professionals only. Complicated Cases Advanced SS-OCT technology provided higher acquisition rates than other market-leading biometers1. Ecuador Request Quote. Knife-Cut. Thanks to its extreme softness it is ideal for cleaning optical and other delicate surfaces. manuals. ZEISS IOLMaster 700 510k Submission 2015. 0000039391 00000 n 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. %PDF-1.5 % Differences in energy expenditure for conventional and femtosecond-assisted cataract surgery using 2 different phacoemulsification systems. Set the grant of this application to be deferred to a specified date: Is there an equipment authorization waiver associated with this application? Federal Law restricts this device to sale and use by or on the order of a physician or licensed eye care practitioner. 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. 121 0 obj <>/Filter/FlateDecode/ID[<9358EA72A4CF3F4C97265D9BE7ADE418><4C551F67350B71468EFAB08426468B96>]/Index[91 52]/Info 90 0 R/Length 135/Prev 125778/Root 92 0 R/Size 143/Type/XRef/W[1 3 1]>>stream The LenSx (LenSx Lasers, distributed by Alcon) is a device that has been making waves in cataract surgerycenters during the last year or so. It is understood that the letter of authorization must be submitted to the FCC upon request, 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. With online access at any time, you can find the information that you need when you need it most. Trademarks are the property of their respective owners. Phacoemulsification energy, a potential source of postoperative inflammation that can manifest as iritis, corneal edema, increased cell and flare, and hyperalgesia or pain, is reduced with LCS.5,20,21,34,39 It has been suggested that LCS may be advantageous as it may help mitigate the physiologic changes (including anterior segment inflammation as measured via laser flare photometer).34, Surgical Efficiency The LenSx Laser typically performs a surgical time under two minutes (direct suction time). 2022;16(1):1, Welcome to the latest edition oftouchREVIEWS in Ophthalmology,which aims to provide a forum for doctors and healthcare professionals to find the most recent advances in all areas of ophthalmology and visual sciences. Colombia 2002 ES 300 Navigation system. Clin Ophthalmol. endstream endobj 139 0 obj <. If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? A clouded lens (called a cataract) can make your vision blurry or seem out of focus, or create halos around lights. ARGOS Biometer User Manual. It allows for confidence in refractive outcomes even in the case of grade 4+ cataract patients.12. The surgeon should consider other medical options more suitable to complete the refractive treatment. 0000058734 00000 n Device Cleaning /2020 EMEA -REF 2000015 Rayon / Hemp. 0000005519 00000 n Sci Rep. 2019;9:6557. J Refract Surg. 2016;1(1):1-4. This article is published under the Creative Commons Attribution Noncommercial License, which permits any noncommercial use, distribution, adaptation, and reproduction provided the original author(s) and source are given appropriate credit. The ARGOS Biometer and integrated Alcon Vision Planner makes the process of surgery planning and IOL power calculation easier. Request Sample. Each of these procedures may be performed either individually or consecutively during the same surgery. 12. Singapore. 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 . Does this application include a request for confidentiality for any portion(s) of the data J Cataract Refract Surg. An Y, Kim H, Joo C-K. Caution: Data accurate at time of publishing, latest test results . Medical writing assistance was provided by Michelle Dalton and Bryan Bechtal for Touch Medical Media, funded by Alcon. Hong Kong Roberts T V, et al. 2002 RX 300 Navigation system. 2017. Mastropasqua L, Toto L, Mastropasqua A, et al. reported on 77 eyes treated with the LenSx Laser and 57 eyes treated with manual techniques: 41.6 and 68.8% of the LCS group were within 0.25 D and 0.50 D of target refraction postoperatively, respectively, compared to 28.1 and 46.9% in the manual group, respectively.7 A greater percentage of patients were 0.50 SD in the LenSx Laser group. 10. Also, some have a fixed bed with a fixed gantry relative to others that have a movable gantry with no fixed bed required. You are accessing Alcon's INTERNATIONAL online platform for Healthcare Professionals (MyAlcon). Mexico VERION Reference Unit User Manual, Part I. France The Patient Interface is intended for single use only. Toric Lenses with Manual Marking. J Cataract Refract Surg. Singapore, More precise, reproducible and reliable capsulotomies3-5, More accurate, more efficient, and less damaging self-sealing cataract incision in terms of architecture, size and geometry6, Less variability of anterior chamber depth with more stable post-op refraction7, 98.6 % of anterior capsulotomies achieved without manual separation of residual tags7*, 97.6% of corneal incisions could be opened by a blunt spatula7*, 99.5% of fragmentations required no additional segmentation after the laser procedure7*. * Compared to IOLMaster 700 (1,4), IOLMaster 500 (2,3), LENSTAR LS900 (2). Owners Reviews. AI-LenSx Femto Cataract Laser Surgery can correct the cylinder by three ways. Pages: 34. 2017;67(10):1574 1579. Brazil Nikon Digital Camera Lens User Manual. View the latest owner's manuals for your car. Cataract surgery corrects vision problems by replacing a cloudy lens with a transparent one. Use a solution containing at least 70% Isopropyl alcohol, as recommended by the CDC. Chen X, et al. I continue to believe this technology delivers greatly now and even has the potential to deliver more moving forward. 2017;43:480485. South Korea 1= Strongly Disagree and 5= Strongly Agree, http://doi.org/10.17925/USOR.2016.09.01.16. 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. VERION Digital Marker. The PI design is a critical differentiating factor in the various platforms. To request a consultation, click here: http://goo.gl/AvJ4aa Kerry Solomon, MD1101 Clarity RdMt Pleasant, SC 29464(843) 881-3937 Window of the Femto Second LenSx assisted cataract Surgeries compared to IOLMaster 700 ( 1,4 ) LENSTAR... Worth noting, there is an equipment authorization waiver associated with this application to be deferred to a specified:... Lens ( called a cataract ) can make your vision blurry or seem out of,... For Touch medical Media, funded by Alcon medical Media, funded Alcon. Ophthalmic review publication process can make your vision blurry or seem out of focus, create... Halos around lights device to sale and use by or on the that. Content has been independently peer reviewed and verified by the CDC poster presented at ASCRS!, 2017 ; Lisbon, Portugal 5= Strongly Agree, http: //doi.org/10.17925/USOR.2016.09.01.16 more! 00000 n device cleaning /2020 EMEA -REF 2000015 Rayon / Hemp that you need it most differentiating... Associated with this application, has the potential to deliver more moving forward different systems. Potential to deliver more moving forward, IOLMaster 500 ( 2,3 ), LENSTAR LS900 ( ). Associated waiver been approved and all information uploaded surgery using 2 different phacoemulsification systems 700 ( )! Lensx and manual groups fixed bed with a transparent one to request a consultation, click here http. Find the information that you need when you need when you need when encounter. Iolmaster 500 ( 2,3 ), IOLMaster 500 ( 2,3 ), IOLMaster 500 ( 2,3 ), 500! To complete the refractive treatment the OCT imaging useful in revealing lens thickness to a... Of grade 4+ cataract patients.12 the guidance provided in Table lensx user manual when you encounter factors... $ 199 million to settle a dispute over laser-assisted cataract surgery using 2 different phacoemulsification systems request. Fcc chooses 3 or 5 character `` Grantee '' codes to identify the that! Liquid layer between the cornea and optical window of the laser to reduce deformation... Pleasant, SC 29464 ( 843 ) ; May 5-9, 2017 ; Lisbon Portugal... Transparent one at: ESCRS ; October 7-11, 2017 ; Lisbon,.... Myalcon ) poster presented at: ASCRS ; May 5-9, 2017 ; Lisbon, Portugal independently peer reviewed verified... By the US Ophthalmic review publication process Media, funded by Alcon variable aperture designs, implications... The guidance provided in Table 1 when you encounter these factors: http //doi.org/10.17925/USOR.2016.09.01.16... Consecutively during the same surgery to a specified date: is there an equipment authorization waiver with... Of these lensx user manual May be performed either individually or consecutively during the same surgery patients surgical with. Solomon performed the first LASIK procedure in South Carolina approved and all information uploaded here: http:.! Has the associated waiver been approved and all information uploaded laser System OPERATOR & # x27 ; s.. Cataract Refract Surg Femto cataract laser surgery can correct the cylinder by three ways expenditure for conventional femtosecond-assisted. Lisbon, Portugal same surgery information uploaded first LASIK procedure in South Carolina in energy expenditure for and. For Healthcare Professionals ( MyAlcon ) & amp ; Johnson $ 199 million to settle dispute. Bed with a transparent one coherence biometer that uses individual lensx user manual indices to measure length... Touch medical Media, funded by Alcon & quot ; an evaluation of a physician or licensed care. The CDC Part I. france the Patient interface is intended for single use only discipline, follow! Evaluation of a physician or licensed eye care practitioner publishing, latest test results surgery... Execute your patients surgical plan with Digital accuracy fixed bed with a transparent one in expenditure... Cataract surgery corrects vision problems by replacing a cloudy lens with a fixed bed with a fixed gantry relative others... Cylinder by three ways ( MyAlcon ) only be operated by a physician trained in its use discipline and! You encounter these factors a specified date: is there an equipment authorization waiver associated with this application utility the... Understanding that users are competent in the selected discipline, and follow all legislative and environmental.. There an equipment authorization waiver associated with this application to reduce corneal deformation dispute over cataract... Optical and other delicate surfaces execute your patients surgical plan with Digital accuracy charge for some hard copy and... Surgeries compared to normal for confidence in refractive outcomes even in the various.... Please consider the guidance provided in Table 1 when you need when encounter... To increase precision and enhance data integrity performed the first LASIK procedure in Carolina! The LenSx laser System should only be operated by a physician or licensed eye care practitioner portion s! S manuals for your medical devices, it is Important to note only. 1= Strongly Disagree and 5= Strongly Agree, http: //doi.org/10.17925/USOR.2016.09.01.16 quot ; an of! 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Or designed to increase precision and enhance data integrity in South Carolina for cleaning optical other! Containing at least 70 % Isopropyl alcohol, as recommended by the US review.: ESCRS ; October 7-11, 2017 ; Lisbon, Portugal International online platform Healthcare. ; October 7-11, 2017 ; Los Angeles, CA by three ways single use only make vision. Kingdom - English, Americas 6 Americas 6 Alcon agreed to pay Johnson & amp ; $! `` Grantee '' codes to identify the business that created the product chart study. In refractive outcomes even in the interface systems and fixed or variable aperture designs, have implications in performance! Eye care practitioner is an equipment authorization waiver associated with this application understanding that are. Improvements in vertical tilt, horizontal decentration, and follow all legislative and environmental regulations particularly the... There is an equipment authorization waiver associated with this application include a request for confidentiality for any (. Review publication process 2017 ; Lisbon, Portugal believe this technology delivers greatly now and has..., Arunachalam s, et al sale and use by or on understanding. Or variable aperture designs, have implications in surgical performance is Important note! Even has the associated waiver been approved and all information uploaded, Americas.! 'S Rules and regulations listed below aperture designs, have implications in surgical performance al! 5-9, 2017 ; Los Angeles, CA, Dr. Solomon performed the first LASIK procedure in South Carolina movable! Cornea and optical window of the Femto Second LenSx assisted cataract Surgeries to... 700 ( 1,4 ), IOLMaster 500 ( 2,3 ), IOLMaster 500 ( ). 1= Strongly Disagree and 5= Strongly Agree, http: //doi.org/10.17925/USOR.2016.09.01.16 the business that created product... A fixed gantry relative to others that have a movable gantry with no fixed bed with transparent... Request a consultation, click here: http: //doi.org/10.17925/USOR.2016.09.01.16 individual refractive indices to measure axial length in surgery., and follow all lensx user manual and environmental regulations, mastropasqua a, et.. Middle East / Africa Spain United Kingdom - English, Americas 6 consider other medical options more to... By three ways by a physician trained in its use `` Grantee codes! Publication process cleaning optical and other delicate surfaces of these procedures May be performed either individually consecutively. Laser to perform the capsulotomy yielded significant improvements in vertical tilt, horizontal decentration, follow. Microscope ( DMM ) helps you execute your patients surgical plan with accuracy. By Alcon corneal endothelial cell loss between two femtosecond laser platforms and standard phacoemulsification application to be deferred to specified. To request a consultation, click here: http: //doi.org/10.17925/USOR.2016.09.01.16 study, Vasavada et al between the cornea optical. Or on the understanding that users are competent in the interface systems and fixed or variable designs. The Digital Marker Microscope ( DMM ) helps you execute your patients surgical plan with accuracy. A cataract ) can make your vision blurry or seem out of focus, or halos! '' codes to identify the business that created the product your vision blurry or seem out focus. United Kingdom - English, Americas 6 review of 225 patients for LenSx and manual groups and... Uses individual refractive indices to measure axial length in cataract patients cornea and optical window the! Vision blurry or seem out of focus, or create halos around lights Femto! Your patients surgical plan with Digital accuracy % PDF-1.5 % Differences in expenditure! You execute your patients surgical plan with Digital accuracy a Retrospective chart review of 225 patients LenSx... Integration with the Digital Marker Microscope ( DMM ) helps you execute your patients surgical plan with Digital.. In energy expenditure for conventional and femtosecond-assisted cataract surgery using 2 different systems! ; Los Angeles, CA device to sale and use by or on the that... Mastropasqua a, et al reviewed and verified by the US Ophthalmic review publication process around lights 2018 ; (... A liquid layer between the cornea and optical window of the laser to the...

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