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AcrySof
®
IQ PanOptix
®
Family of Trifocal IOLs Important Product Information
CAUTION: Federal (USA) law restricts this device to the sale by or on the order of a physician. INDICATIONS: The AcrySof
®
IQ PanOptix
®
Trifocal IOLs include AcrySof
®
IQ PanOptix
®
and AcrySof
®
IQ
PanOptix
®
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, 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 AcrySof
®
IQ PanOptix
®
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 AcrySof
®
IQ PanOptix
®
Toric Trifocal IOL, 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 or starbursts, 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 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 AcrySof
®
IQ PanOptix
®
Trifocal IOLs. ATTENTION: Reference
the Directions for Use labeling for each IOL for a complete listing of indications, warnings and precautions.