Alcon Research, Ltd. recalls Expansion of previous recall of AcrySof IQ ReSTOR and AcrySof IQ ReSTOR Toric IOL; now to include AcrySof IQ Toric mode…

Recall date

September 29, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0271-2016

FDA classification

Class I

Brand / firm

Alcon Research, Ltd.

Sold / distributed

International Only Distribution -- Japan.

Why it was recalled

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

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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.