FDA Clears New Corrective Intraocular Lens From Alcon

Megan Brooks

Disclosures

February 03, 2017

The US Food and Drug Administration (FDA) has approved a new intraocular lens (IOL) designed to address presbyopia and pre-existing corneal astigmatism at the time of cataract surgery in adults.

The AcrySof IQ ReSTOR +3.0D Multifocal Toric IOL from Alcon is already available in the European Union, Australia, Canada, and many countries in Central and South America and Asia, the company said in a news release.

"Correcting presbyopia and astigmatism, with one lens, at the time of cataract surgery is a great benefit to patients and can improve patient satisfaction," Stephen Lane, MD, medical director, Associated Eye Care, and adjunct clinical professor, University of Minnesota, Minneapolis, said in the release.

"The introduction of this advanced technology IOL gives us an additional treatment option to help reduce dependence on spectacles for patients with astigmatism," Dr Lane added.

The AcrySof IQ ReSTOR +3.0 D Multifocal Toric IOL corrects corneal astigmatism only when placed in the correct position in the eye, the company notes in the release. "There is a possibility that the IOL could be placed incorrectly or could move within the eye. This may result in less improvement or a reduction in vision because your corneal astigmatism has not been fully corrected, or it may cause visual symptoms," they said.

Side effects associated with the AcrySof IQ ReSTOR +3.0 D Multifocal Toric IOL include visual disturbances, such as glare, rings around lights, and blurred vision. These side effects may make it more difficult to see while driving at night or completing tasks in low lighting, such as at night or in fog, after surgery as compared with before surgery.

The safety and effectiveness of the AcrySof IQ ReSTOR +3.0 D Multifocal Toric IOL has not been demonstrated in patients with certain eye conditions, such as glaucoma or diabetic retinopathy.

Alcon said it plans to commercialize the AcrySof IQ ReSTOR +3.0D Multifocal Toric IOL in the United States on a rolling basis starting now.

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