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Alcon Research, Ltd. recalls Expansion of previous recall of AcrySof IQ ReSTOR and AcrySof IQ ReSTOR Toric IOL; now to include AcrySof IQ Toric model
Recalled December 2, 2015 · FDA recall Z-0271-2016 · Alcon Research
Hazard
Continued increase in reports of post-operative inflammation in patients who received AcrySof IQ Toric IOL. · FDA Class I
Units
43,651 units
Sold at
International Only Distribution -- Japan.
Description
Continued increase in reports of post-operative inflammation in patients who received AcrySof IQ Toric IOL.
Product
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.
Manufacturer(s)
Alcon Research, Ltd.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →