2017;43:16 21. 1. LenSx Laser Cataract Surgery It may offer greater globe stability against pulsatile and ocular movements relative to noncontact interfaces, which may result in more consistent laser patterns and smoother morphology at the capsulotomy edge, compared to the Catalys* and Victus* systems.8 The fixation and stability of the eye with the SoftFitTM PI contributes to the LenSx Lasers ability to do high-quality, complex corneal work, while also being able to accurately and effectively perform capsulotomies and lens fragmentation. Santec Letter of Declaration. More precise, reproducible and reliable capsulotomies, More accurate, more efficient, and less damaging self-sealing cataract incision in terms of architecture, size and geometry, Less variability of anterior chamber depth with more stable post-op refraction, 98.6 % of anterior capsulotomies achieved without manual separation of residual tags, 97.6% of corneal incisions could be opened by a blunt spatula, 99.5% of fragmentations required no additional segmentation after the laser procedure, On average, laser cataract patients spend less time in the OR, Per patient, significant time savings were observed in the following categories. Owners Reviews. Each platform incorporates anterior segment imaging, a patient interface (PI), and a femtosecond laser. 2015;41(5):1109-1110. SoftFitTM PI uses a soft contact lens insert at the interface to minimize corneal compression. 0000007536 00000 n This page is available in English. *Prospective, multicenter study investigated performance of FLACS at 1 month post-op in Chinese patients (n = 1542 eyes). Hong Kong addition to our existing device-specific directions for use and manuals of operation, Alconis 2019. The LenSx Laser System should only be operated by a physician trained in its use. 2018. Description of product as it is marketed: UiqFc XLZN! Uruguay Alcon equipment, Made up of tenured ophthalmic technicians Chile The LenSx Laser, Catalys* and Victus* systems use high-definition optical coherence tomography (HD OCT), while LENSAR* uses Scheimpflug imaging technology. It . See 47 CFR 1.2002(b) for the Tran, D, Vargas, V, Potvin, R. Neodymium:YAG capsulotomy rates associated with femtosecond laser-assisted versus manual 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. ./&oWzSuCE|Kk9!bde1tmH&FQvj\C!P* Is there a KDB inquiry associated with this application? 41 0 obj <> endobj The LenSx and Catalys laser platforms demonstrate similar capsulotomy outcomes. 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. The Patient Interface is intended for single use only. Comparison of the refractive outcomes in patients with dense nuclear cataract between the ARGOS Biometer and IOLMaster* 70012. Chan T, et al. Smart Clock CD-24501F Manual. Owner's Manuals Online Repair Manuals We're committed to providing service and repair information in accordance with EU guidelines. A clouded lens (called a cataract) can make your vision blurry or seem out of focus, or create halos around lights. 2018. 2016;42:50-61. 1. 0000001520 00000 n p<0.001, <2 minutes total time for patients under suction in cataract procedures16, As strong as manual LenSx capsulotomy integrity17, <0.1% capsular tear rate with SoftFit Patient Interface12, 13. Singapore. This platform is intended to provide general product information for education and illustration purposes. 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 `eoo (B?A This prospective study enrolled 64 eyes (54 patients) with high myopia with low to moderate regular corneal astigmatism. Show Description +. ^>{.4Ke- The content has been independently peer reviewed and verified by the US Ophthalmic Review publication process. 2020;14:1511-1519. Femtodelineation was shown to help avoid vertical pressure that may result from injecting liquid, thus mitigating the risk of posterior capsule blowout. Sci Rep. 2019;9:6557. It helps us to continually improve our products. Dynamic overlays can help to precisely execute incisions, Image-guided integration can help to achieve greater capsulorhexis accuracy, Precisely align toric IOLs according to your planned implantation axis, mapped to your patients unique limbal and iris landmarks, An image of the final IOL position is captured and stored for future reference, Seamlessly integrate the surgical planning process. Br J Ophthalmol. Aperio GT 450. Russia, Asia Pacific 2017;20(9):A800A801. The microadhesions that were demonstrated in three cases in the LenSx group did not lead to intraoperative or postoperative complications. %PDF-1.5 % 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 Future Directions J Cataract Refract Surg. Ecuador Intraoperative Uses Corneal Incisions Alcon Laboratories, Inc. 6201 South Freeway Distrubuted By: Fort Worth, TX 76134-2099 USA Alcon Laboratories, UK Ltd. Pentagon Park, Boundary Way Hemel Hempstead Hertfordshire, HP2 7UD, UK. Chile * Trademarks are the property of their respective owners. It is understood that the letter of authorization must be submitted to the FCC upon request, Kranitz et al. The procedure is computer-controlled, precise and predictable. In 1996, Dr. Solomon performed the first LASIK procedure in South Carolina. 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. endstream endobj 139 0 obj <. 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. Accuracy of IOL power formulas with true axial length versus simulated axial length measurement in 318 eyes using an OCT biometer. 2017. For your medical devices, it is important to note that only John Davidson, MD, received compensation from Alcon for his contributions to this hbbd```b`` Italy 0000010625 00000 n JCataract Refract Surg. for possession or distribution of a controlled substance. The ARGOS Biometer keratometry measurements show high correlation with IOLMaster* 500, IOLMaster* 700 and LENSTAR*.2,13. We are trying to determine if the laser . 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. VERION Digital Marker. ATTENTION: Refer to the LenSx Laser Operators Manual for a complete listing of indications, warnings and precautions. Toric Lenses with Verion Digital Axis Marking. December 2018. E: doctorjohn@johndavidsonmd.com. 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. The LenSx Laser (http://goo.gl/z5OP0t) for refractive cataract surgery has been described as a surgical breakthrough. If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? J Cataract Refract Surg. United Nations Department of Economic and Social Affairs Population Division, World Population Ageing 2013. 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 LenSx Laser System Bring proven precision and safety to every cataract procedure with the LenSx Laser, featuring ASCEND Technology the market leading femtosecond platform.1-13 Get Started Proven Precision Reproducibility and accuracy at every step.3-7 Compared to manual procedures, LenSx Laser delivers: Performance of femtosecond laser-assisted cataract surgery in Chinese patients with cataract: a prospective, multicenter, registry study. 0000093732 00000 n 0 Shammas HJ, Ortiz S, Shammas MC, Kim SH, Chong C. Biometry measurements using a new large-coherence-length swept-source optical coherence tomographer. 0000039391 00000 n These letters are chosen by the applicant. ARGOS Optical Biometer Important Product InformationCaution: Federal (USA) law restricts this device to the sale by or on the order of a physician. additional equipment authorization? May 2018 in COMPLIANCE. have been made with the manufacturer to ensure that production units of this equipment A retrospective comparison of clinical outcomes associated with manual and femtosecond laser cataract surgery. Europe / Middle East / Africa * Retrospective chart review of 225 patients for LenSx and manual groups. LenSx Crnea. While it's often marketed as "laser cataract surgery," this is an oversimplification of both the device and the surgeon's role in surgery. 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 . The LenSx Laser (http://goo.gl/z5OP0t) for refractive cataract surgery has been described as a surgical breakthrough. ARGOS Biometer has shown better predictive accuracy in medium-long eyes than IOLMaster 500 (7,8). 2019;19:1-13. Italy at Alcons state-of-the-art training facilities, Hands-on training with Alcon advanced : Does short-term confidentiality apply to this application? Welcome to the winter edition oftouchREVIEWS in Ophthalmology, which features relevant topics from across the specialty. SMARTCataract seamlessly connects data systems, diagnostic devices and surgical equipment from the clinic to the OR. 0000009132 00000 n DXX - Part 15 Low Power Communication Device Transmitter. 2016;1(1):1-4. See Prices; Nikon Camera Lens 105mm F/2.8. MOVU ARGOS 510(k) Summary 2019. that operates with, or is marketed with, another device that requires an equipment authorization? Request Sample. Holladay et al. 64 0 obj <> endobj xref The laser platforms utilize either a contact or non-contact PI. 2 - Software LenSx Cornea. Argentina On July 6, LenSx and Alcon announced details of a deal worth at least $361.5 million in cash. 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*. 0 reported on 3,355 cases operated at their facility using LenSx Laser (734 with a rigid interface and 2,621 with the SoftFit PI).18 The authors reported an overall complication rate of 0.21%, which compared favorably to the 0.31% complication rate noted in their earlier study. Cleanroom wipes, Lensx 90. The interface to minimize corneal compression 64 0 obj < > endobj the LenSx Laser Operators for... 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