FDA
18th November 2014

FDA Panel Recommends Premarket Approval Application for AcrySof IQ ReSTOR multifocal toric IOL

The multifocal toric IOL lens is designed to treat cataracts and correct presbyopia. The proposed indication for the combination IOL, as stated in Alcon’s submission.

FDA Panel Recommends Premarket Approval Application for AcrySof IQ ReSTOR multifocal toric IOL

On Friday, the U.S. Food and Drug Administration Ophthalmic Devices Panel of the Medical Devices Advisory Committee voted unanimously in favor of the premarket approval application for the AcrySof IQ ReSTOR +3.0 D multifocal toric intraocular cataract lens (IOL), submitted by Alcon. The materials for this meeting can be found HERE.


The multifocal toric IOL lens is designed to treat cataracts and correct presbyopia. 
The proposed indication for the combination IOL, as stated in Alcon’s submission, is for “primary implantation for the visual correction of aphakia and preexisting astigmatism secondary to removal of a cataractous lens in adult patients with and without presbyopia who desire near, intermediate and distance vision, reduction of residual refractive cylinder and increased spectacle independence.” 

The two voting questions asked of the committee during this meeting had to do with whether the panelists feld there was reasonable assurance that the AcrySof IQ ReSTOR multifocal toric posterior chamber IOL is safe for use in patients who meet the criteria specified in the proposed indication and whether there is reasonable assurance that the lens is effective for use in patients who meet those criteria.

The panel voted 11-1 that the benefits of the IOL outweigh the risks for use in patients who meet the criteria specified in the proposed indication.

“Despite a little bit of controversy about the patient subjective outcomes, I think the objective data was compelling,” noted Bennie H. Jeng, MD, MS of the FDA’s Ophthalmic Devices Panel.  

ISS has over a decade of experience in developing regulatory strategies including support for FDA Advisory Committee meetings. We are involved in more FDA AdComs per year than even the largest pharmaceutical companies. For more information on how ISS can help you prepare for your next meeting, contact info@innovativescience.net.

Do you have an upcoming Advisory Committee Meeting?

White Oak Gude

Recent Related Articles

Best Tips for Medical Device Manufacturers to Write a Compelling Substantial Equivalence Section for their FDA 510k Submission
01 July 2020
Best Tips for Medical Device Manufacturers to Write a Compelling Substantial Equivalence Section for their FDA 510k Submission

Over the past few years, the number of ex-US manufacturers submitting a Class II exempt 510k device registration has increased substantially. For companies with medical devices that are approved and successful in a foreign market, the logical next step is to introduce their product into the US, which has one of the most lucrative healthcare markets in the world. Read more

Evolving FDA Thinking on Advisory Committee Meetings Related to Foods, Drugs, and Devices
25 June 2020
Evolving FDA Thinking on Advisory Committee Meetings Related to Foods, Drugs, and Devices

FDA advisory committee meetings are important regulatory events for many manufacturers on the path to marketing approval. These meetings can quite literally result in the approval or rejection of a product based on the panel’s vote. Read more

NDA vs. OTC Monograph: Which Pathway is Right for You?
22 June 2020
NDA vs. OTC Monograph: Which Pathway is Right for You?

One of the main challenges our clients face is determining which regulatory pathway is best for their products. For example, what if an OTC product has a Monograph active ingredient but that ingredient is present at a different amount than the permitted amount? Or what if the label claims a novel indication not specified in a Monograph? If you are debating pursuit of either regulatory pathway for your OTC drug, it is critical to consider cost, timeline, and label claims to ensure your products has a unique stance in today’s market. Read more

4 Problems Importing Rapid Antibody Tests for Coronavirus
19 June 2020
4 Problems Importing Rapid Antibody Tests for Coronavirus

US distributors and agents trying to import rapid antibody tests for coronavirus face a number of obstacles. The good news is that FDA has opened up the Emergency Use Authorization (EUA) program to include SARS-CoV-2 (the virus) and COVID-19 (the disease), expediting time to market. Read more

Let’s work together

The journey to scientific and commercial success is often complex and always critical, if you are looking for an expert partner to help steer you to confident solutions, contact us today

Contact us