Filkorn et al. * Retrospective chart review of 225 patients for LenSx and manual groups. 0000039322 00000 n
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. Generational improvements in software and hardware have already produced additional laser patterns, auto pre-positioning, speed and improvements in the PI, the latter of which confers greater control of the globe and more precise laser delivery. 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. Brazil Does this application include a request for confidentiality for any portion(s) of the data J&J accused Alcon in 2020 of infringing on 12 of its U.S. patents by selling the LenSx Laser System. 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. 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 J&J subsequently expanded the case to cover copyright infringement claims and began a parallel challenge to Alcon in Europe. used electron microscopy to analyze the edge characteristics of capsulorhexes cut with manual techniques compared with capsulotomies performed with two generations of the LenSx Laser platform (LenSx Laser pre-SoftFitTM PI version 2.16 and LenSx Laser post-SoftFitTM PI version 2.20), two generations of the Victus* platform (Victus I version 2.5 and Victus II version 2.7SP2), and Catalys* (version 2.15.13). Automobile. Medical writing assistance was provided by Michelle Dalton and Bryan Bechtal for Touch Medical Media, funded by Alcon. %PDF-1.5
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My preferred routine pattern utilizes three chops that divide the lens nucleus into six segments, allowing efficient removal of the nucleus without leaving a posterior nuclear plate that can be difficult to safely remove. May 2018 in COMPLIANCE. France 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. 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. The surgeon should consider other medical options more suitable to complete the refractive treatment. ManualsLib has more than 563 Lexus manuals. 0000089128 00000 n
Comparison of axial length using a new swept-source optical coherence tomography-based biometer. Russia, Asia Pacific SUV. In addition, Lensx 90 is used for number of other lens cleaning applications including microscopes, camera lenses, telescopes, IR lenses, fiber optics, and other sensitive optical components in laboratory, cleanroom, and industrial settings. endstream
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y; ;,O?VY1Np9v5mnk08LM|}kM9/LJthG$I&BhIfk\IGrM~LGog ?GC/4IHJ-vp*! Description of LenSx (Alcon) machine and its use in Femtosecond Laser-Assisted Cataract Surgery (FLACS). I have found the OCT imaging useful in revealing lens thickness. Image Guided Integration from the clinic to the OR designed to increase precision and enhance data integrity. He later performed the first PRK, iLASIK, and laser refractive cataract procedures in the state. LenSx Laser Cataract Surgery Ophthalmology. Also, some have a fixed bed with a fixed gantry relative to others that have a movable gantry with no fixed bed required. Knife-Cut. 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. 2019;19:7. A retrospective comparison of clinical outcomes associated with manual and femtosecond laser cataract surgery. %%EOF
Instructions For Use Manual Instructions For Use Manual Instructions For Use Manual. On July 6, LenSx and Alcon announced details of a deal worth at least $361.5 million in cash. 0000002723 00000 n
2012;28(4):259263. Comparison of characteristics of femtosecond laser-assisted anterior capsulotomy versus manual continuous curvilinear capsulorrhexis: a meta-analysis of 5-year results. technology, individualised for your clinics needs, Tamaoki A, Kojima T, Hasegawa A, et al. South Korea Zhang X, et al. These letters are chosen by the applicant. It is important to note that only cleaning products that have . 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. 1. hb``g``: $,P#0p4 C1C( c/$zLuX1~b`pCQOx3i'Oxk>gX-LA30p Models. Dr. McCabe may be reached at (941) 792-2020; cmccabe13@hotmail.com. Applicant's complete, legal business name: A1: Low Power Transmitters below 1 GHz (except Spread Spectrum), Unintentional Radiators, EAS (Part 11) & Consumer ISM devices. HVoF~7/t|:/ @c]f{H:c R[)d#eG#yyZUl^IM~"[,ZE@I.2*l6oPz8@RU,$dH4|~e
_OC.0#e ]ED']S;Fyei"/2I"_e3TkJ,T*DiKu#c%fOA!IEK]*C If an agent has signed this application on behalf of the applicant, a written letter of 5 - Manejo de las complicaciones. Further, the mean absolute error (MAE), a measure of predictability, was lower in the LenSx Laser group. South Korea The LenSx Laser delivery system employs one sterile disposable Patient Interface consisting of an applanation lens and suction ring. 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. 4 - Contraindicaciones. Uruguay BUY A NEW CAR ONLINE. 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. IOL alignment with the visual axis is important to achieve the targeted refractive outcome. ARGOS Biometer has shown better predictive accuracy in medium-long eyes than IOLMaster 500 (7,8). Europe / Middle East / Africa In accepting a Grant of Equipment Authorization as a result of the representations made in this Pages: 22. Indications, contraindications and description of the docking technique with personal. Alcon sponsored the publication of this promotional piece. Russia, Asia Pacific Hussaindeen JR, Mariam EG, Arunachalam S, et al. 2016;10:20212029. 2018. J Cataract Refract Surg. Spain Kranitz et al. 0
Kohnen T, Mathys L, Petermann K, et al. Furthermore, several capsules generated by Catalys* and Victus* II showed tracks of pulses that appeared to have been misdirected inside the capsulotomy. Check if a local MyAlcon page for your country to access country product information. UX Available to buy online HYBRID SUV . 0000001520 00000 n
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Singapore. (U.S. CODE, TITLE 18, SECTION 1001), AND/OR REVOCATION OF ANY STATION LICENSE OR User Manual. Alcon LenSx User Manuals User manual instruction guides for Alcon LenSx devices. China 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. 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. 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