For Neel Desai, MD; Arjan Hura, MD; Cristos Ifantides, MD; Neda Shamie, MD; David Stephens, MD; Toby Tyson, MD; and Caroline Watson, MD, one thing is certain: patients want advanced technology. Now, surgeons have the ability to rise up to the next level by improving on the Vivity® and PanOptix® IOLs with the Clareon® material.
SEE PAST ISSUES and “Rising Up” on Eyetube to hear from more surgeons who are rising up with Clareon PanOptix and Vivity.
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.
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Clareon trademark information. All other brand/product names are the trademarks of their respective owners.