Class I — Serious Health Hazard

Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

Expansion of previous recall of AcrySof IQ ReSTOR and AcrySof Recalled by Alcon Research, Ltd. Due to Continued increase in reports of post-operative inflammation in...

Date: September 29, 2015
Company: Alcon Research, Ltd.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Alcon Research, Ltd. directly.

Affected Products

Expansion of previous recall of AcrySof IQ ReSTOR and AcrySof IQ ReSTOR Toric IOL; now to include AcrySof IQ Toric models SN6AT6, SN6AT7, SN6AT8, and SN6AT9. Intended for primary implantation in the capsular bag of the eye for visual correction.

Quantity: 43,651 units

Why Was This Recalled?

Continued increase in reports of post-operative inflammation in patients who received AcrySof IQ Toric IOL.

Where Was This Sold?

International Only Distribution -- Japan.

About Alcon Research, Ltd.

Alcon Research, Ltd. has 26 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report