*Based on in vitro examinations of glistenings, surface haze and SSNGs. †Defined as modified Miyata grade 0, <25mv /mm2 over 3 years (n=138 ), and over 9 years (n=20 ), respectively.
††Clareon® and AcrySof® share the same -0.2μm aspheric design resulting in improved depth of focus.
IMPORTANT PRODUCT INFORMATION – CLAREON® ASPHERIC FAMILY OF HYDROPHOBIC ACRYLIC IOLS
CAUTION: Federal law restricts this device to sale by or on the order of a physician.
INDICATION: The Clareon® Aspheric Hydrophobic Acrylic IOLs include the Clareon® Aspheric and Clareon® Aspheric Toric IOLs and are indicated for primary implantation in the capsular bag in the posterior chamber of the eye for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed. In addition, the Clareon® Aspheric Toric IOL is indicated to correct pre-existing corneal astigmatism.
WARNINGS/PRECAUTIONS: The Clareon® IOL is intended for implantation in the capsular bag only. Physicians considering lens implantation under any of the following circumstances should weigh the potential risk/benefit ratio: Patients in whom the posterior capsule is ruptured, zonules are damaged, or primary posterior capsulotomy is planned. Careful preoperative evaluation and sound clinical judgment should be used by the surgeon to decide the risk/benefit ratio before implanting the IOL in a patient with any of the conditions described in the Directions for Use. For the Clareon® Aspheric Toric IOLs, rotation can reduce astigmatic correction; if necessary lens repositioning should occur as early as possible prior to lens encapsulation. As with any surgical procedure, there is risk involved. Potential complications accompanying cataract and/or IOL implantation surgery may include, but are not limited to, the following: lens epithelial cell on- growth, corneal endothelial cell damage, infection (endophthalmitis), toxic anterior segment syndrome (TASS), retinal detachment, vitritis, cystoid macular edema, corneal edema, pupillary block, cyclitic membrane, iris prolapse, hypopyon, anterior uveitis, hyphema, pigment dispersion, posterior capsule opacification, transient or persistent glaucoma, and secondary surgical interventions. Secondary surgical interventions include, but are not limited to: lens repositioning, lens replacement, vitreous aspiration or iridectomy for pupillary block, wound leak repair, and retinal detachment repair. Prior to surgery, prospective patients should be informed of the possible risks and benefits associated with this IOL as well as the risks and benefits associated with cataract surgery. After surgery, physicians should provide an implant card to patients regarding the IOL implanted. DO NOT re-sterilize the Clareon® IOL by any method. The device is for single use only.
ATTENTION: Refer to the Directions for Use labeling for a complete list of indications, warnings and precautions.
- Werner L, Thatthamla I, Ong M, et al. Evaluation of clarity characteristics in a new hydrophobic acrylic IOL. J Cataract Refract Surg. 2019;45:1490-1497.
- Lehmann R, Maxwell A, Lubeck DM, Fong R, Walters TR, Fakadej A. Effectiveness and Safety of the Clareon® Monofocal Intraocular Lens: Outcomes from a 12-Month Single-Arm Clinical Study in a Large Sample. Clin Ophthalmol. 2021;15:1647-1657. Published 2021 Apr 20.
- Oshika T, Fujita Y, Inamura M, Miyata K. Mid-term and long-term clinical assessments of a new 1-piece hydrophobic acrylic IOL with hydroxyethyl meth-acrylate. J Cataract Refract Surg. 2020 May;46(5):682-687.
- Maxwell A, Suryakumar R. Long-term effectiveness and safety of a three-piece acrylic hydrophobic intraocular lens modified with hydroxyethyl-methacrylate: an open-label, 3-year follow-up study. Clin Ophthalmol. 2018;12:2031-2037.
- Clareon® IOL Directions for Use.
- Das KK, Werner L, Collins S, Hong X. In vitro and schematic model eye assessment of glare or positive dysphotopsia-type photic phenomena: Comparison of a new material IOL to other monofocal IOLs. J Cataract Refract Surg. 2019;45(2):219-227.
- Alcon Data on File, 2017.
- Lane S, Collins S, Das KK, Maass S, Thatthamla I, Schatz H, Van Noy S, Jain R. Evaluation of intraocular lens mechanical stability. J Cataract Refract Surg.
2019 Apr; 45(4):501-506.
- Steinwender, G., MD, et al. Depth of focus after implantation of spherical or aspheric intraocular lenses in hyperopic and emmetropic patients. J Cataract Refract Surg 2017; 43:1413–1419 Q 2017 ASCRS and ESCRS. Volume 43 Issue 11 November 2017.
- Nanavaty, M., et al. Wavefront aberrations, depth of focus, and contrast sensitivity with aspheric and spherical intraocular lenses: Fellow-eye study. J Cataract Refract Surg 2009; 35:663–671 Q 2009 ASCRS and ESCRS. Vol. 35, April 2009.