IMPORTANT PRODUCT INFORMATION
Clareon® PanOptix® Pro Trifocal IOLs
CAUTION: Federal (USA) law restricts this device to the sale by or on the order of a physician.
INDICATIONS
The Clareon® PanOptix® Pro Trifocal IOLs include Clareon® PanOptix® Pro and Clareon® PanOptix® Pro Toric 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, with less than 1 diopter of pre-existing corneal astigmatism, in whom a cataractous lens has been removed. The lens mitigates the effects of presbyopia by providing improved intermediate and near visual acuity, while maintaining comparable distance visual acuity with a reduced need for eyeglasses, compared to a monofocal IOL. In addition, the Clareon® PanOptix® Pro Toric Trifocal IOL is indicated for the reduction of residual refractive astigmatism.
WARNINGS/PRECAUTIONS: Careful preoperative evaluation and sound clinical judgment should be used by the surgeon to decide the risk/benefit ratio before implanting a lens in a patient with any of the conditions described in the Directions for Use labeling. Physicians should target emmetropia, and ensure that IOL centration is achieved.
For the Clareon® PanOptix® Pro Toric Trifocal IOLs, the lens should not be implanted if the posterior capsule is ruptured, if the zonules are damaged, or if a primary posterior capsulotomy is planned. Rotation can reduce astigmatic correction; if necessary, lens repositioning should occur as early as possible prior to lens encapsulation.
Some visual effects may be expected due to the superposition of focused and unfocused multiple images. These may include some perceptions of halos, radial lines around point sources of light (starbursts) under nighttime conditions, or glare, as well as other visual symptoms. As with other multifocal IOLs, there is a possibility that visual symptoms may be significant enough that the patient will request explant of the multifocal IOL. A reduction in contrast sensitivity as compared to that expected with a monofocal IOL may be experienced by some patients and may be more prevalent in low lighting conditions. Therefore, patients implanted with multifocal IOLs should exercise caution when driving at night or in poor visibility conditions. Patients should be advised that unexpected outcomes could lead to continued spectacle dependence or the need for secondary surgical intervention (e.g., intraocular lens replacement or repositioning). As with other multifocal IOLs, patients may need glasses when reading small print or looking at small objects. Posterior capsule opacification (PCO), may significantly affect the vision of patients with multifocal IOLs sooner in its progression than patients with monofocal IOLs. Prior to surgery, physicians should provide prospective patients with a copy of the Patient Information Brochure available from Alcon informing them of possible risks and benefits associated with the IOLs.
ATTENTION: Reference the Directions for Use labeling for each IOL for a complete listing of indications, warnings and precautions.
