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Home | Light Adjustable Lens from RxSightThe Light Adjustable Lens from RxSight is the first and only FDA-approved lens that can be adjusted after cataract surgery.Home | Light Adjustable Lens from RxSight Skip to content Careers Investors Library Patients Healthcare Professionals About Us Contact Us Patients Healthcare Professionals About Us Contact Us The Only Adjustable Lens for Cataract Surgery RxSight develops the Light Adjustable Lens™ (LAL®)—the only FDA-approved intraocular lens (IOL) that can be customized after cataract surgery.Unlike fixed lenses, the LAL allows your surgeon to fine-tune your prescription after your eye has healed, based on real outcomes rather than pre-surgical estimates. Patients Healthcare Professionals Facebook-f Instagram Youtube Linkedin-in Important Safety Information INDICATIONS: The Light Adjustable Lens™ (LAL®) and Light Delivery Device™ (LDD™) system is indicated for the reduction of residual astigmatism to improve uncorrected visual acuity after removal of the cataractous natural lens by phacoemulsification and primary implantation of the intraocular lens in the capsular bag in adult patients with preexisting corneal astigmatism of ≥ 0.75 diopters and without preexisting macular disease. The system also reduces the likelihood of clinically significant residual spherical refractive errors.CONTRAINDICATIONS: The LAL is contraindicated in patients who are taking systemic medication that may increase sensitivity to ultraviolet (UV) light as the LDD treatment may lead to irreversible phototoxic damage to the eye; patients who are taking a systemic medication that is considered toxic to the retina (e.g., tamoxifen) as they may be at increased risk of retinal damage during LDD treatment; patients with a history of ocular herpes simplex virus due to the potential for reactivation from exposure to UV light; patients with nystagmus as they may not be able to maintain steady fixation during LDD treatment; and patients who are unwilling to comply with the postoperative regimen for adjustment and lock-in treatments and wearing of UV protective eyewear.WARNINGS: Careful preoperative evaluation and sound clinical judgment should be used by the surgeon to decide the risk/benefit ratio before implanting an IOL in a patient with any of the conditions described in the LAL and LDD Professional Use Information document. Caution should be used in patients with eyes unable to dilate to a pupil diameter of ≥ 7 mm to ensure that the edge of the LAL can be visualized during LDD light treatments; patients who the doctor believes will be unable to maintain steady fixation that is necessary for centration of the LDD light treatment; and patients with sufficiently dense cataracts that preclude examination of the macula as patients with preexisting macular disease may be at increased risk for macular disease progression. Patients at high risk for future vitreoretinal disease that may require silicone oil as part of therapy. The LAL must be implanted in the correct orientation with the back layer facing posteriorly. There is no clinical data to demonstrate the safety and effectiveness of ciliary sulcus placement of the LAL. Patients with any of the following conditions may not be suitable candidates for the LAL: recurrent severe anterior or posterior segment inflammation or uveitis of unknown origin, or any disease producing an inflammatory reaction in the eye; surgical difficulties at the time of cataract surgery before LAL implantation; a compromised eye; eyes with neither the posterior capsule nor the zonules are intact enough to provide support for the LAL.PRECAUTIONS: The long-term effect on vision due to exposure to UV light that causes erythropsia (after LDD treatment) has not been determined. The implanted LAL MUST undergo a minimum of 2 LDD treatments (1 adjustment procedure plus 1 lock-in treatment) beginning at least 17-21 days post-implantation. All clinical study outcomes were obtained using LDD power adjustments targeted to emmetropia post-LDD treatments. The safety and performance of targeting to myopic or hyperopic outcomes have not been evaluated. The safety and effectiveness of the LAL and LDD have not been substantiated in patients with certain preexisting ocular conditions and intraoperative complications. Patients must be instructed to wear the RxSight-specified UV protective eyewear during all waking hours after LAL implantation until 24 hours post final lock-in treatment. Unprotected exposure to UV light during this period can result in unpredictable changes to the LAL, causing aberrated optics and blurred vision, which might necessitate explantation of the LAL. Concurrent light treatments in both eyes after bilateral LAL implantation was not performed in the clinical study. Poorer refractive results may occur with the use of corneal sutures if refractive stability is not achieved prior to LDD treatments. Light treatments should be delayed in the case of an ocular adverse event that could be negatively impacted by light treatment or negatively impact the effectiveness or safety of a light treatment.ADVERSE EVENTS: The most common adverse events (AEs) reported in the randomized pivotal trial included cystoid macular edema (3 eyes, 0.7%), hypopyon (1 eye, 0.2%), and endophthalmitis (1 eye, 0.2%). The rates of AEs did not exceed the rates in the ISO historical control except for the category of secondary surgical interventions (SSI); 1.7% of eyes (7/410) in the Light Adjustable Lens group had an SSI (p < .05). AEs related to the UV light from the LDD include phototoxic retinal damage causing temporary loss of best spectacle corrected visual acuity (1 eye, 0.2%), persistent induced tritan color vision anomaly (2 eyes, 0.5%), persistent induced erythropsia (1 eye, 0.3%), reactivation of ocular herpes simplex Infection (1 eye, 0.3%), and persistent unanticipated significant increase in manifest refraction error (≥ 1.0 D cylinder or MRSE) (5 eyes, 1.3%).CAUTION: Federal law restricts this device to sale by or on the order of a physician.Please see the Professional Use Information document for a complete list of contraindications, warnings, precautions, and adverse events.For clinical study data, please see the FDA Summary of Safety and Effectiveness.Click here for more patient information ©2026 RxSIGHT. All Rights Reserved. COM-1043 Rev. T Patents Terms of Use Privacy Policy Declaration of Compliance Patents Terms of Use Privacy Policy Declaration of Compliance The Light Adjustable Lens provides optimized vision for patient satisfaction.2 Light Adjustable Lens patients saw nearly as well without glasses (UCDVA) as control patients did with glasses (BCDVA).Since the Light Adjustable Lens is a monofocal lens, there is low risk of dysphotopsias caused by splitting light, leading to potentially enhanced vision and patient satisfaction. The Light Adjustable Lens offers LASIK-like accuracy in cataract surgery.2,3 92% of eyes (N = 391) achieved results within 0.50 D of target manifest refraction spherical equivalent (MRSE).Patients are approximately two times more likely to achieve 20/20 vision or better without glasses at 6 months.The study was a prospective, controlled, multicenter, 12-month study of 600 patients (ITT population) randomized to receive implantation with the RxSight LAL (N = 403) or a commercially available monofocal IOL (N = 197). Effectiveness analyses included 391 LAL patients and 193 control patients. Primary safety variables included best spectacle-corrected visual acuity (BSCVA) at 6 months and incidence of sight-threatening complications and adverse events. Primary effectiveness variables included percent reduction in manifest cylinder at 6 months, percent mean absolute reduction in MRSE at 6 months, and rotation of meridian of LAL at 6 months. Percent of eyes with an uncorrected visual acuity (UCVA) of 20/20 or better at six months post-operatively compared between the LAL treatment group and the monofocal control group was a secondary endpoint. The Light Adjustable Lens corrects as low as 0.50 D of astigmatism, which is the lowest level approved to be treated. The ability to treat 0.50 D of postoperative cylinder makes the Light Adjustable Lens the only IOL in the United States approved to correct this level of vision-altering astigmatism. Astigmatism of as little as 0.50 D can reduce visual acuity by one line, and the impact on dynamic, functional visual acuity and low-contrast acuity is even greater.1enusen-US1783424881https://rxsight.com

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