FDA-Device2015-12-02Class I
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.
Alcon Research, Ltd.
Hazard
Continued increase in reports of post-operative inflammation in patients who received AcrySof IQ Toric IOL.
Sold states
International Only Distribution -- Japan.
Affected count
43,651 units
Manufactured in
6201 South Fwy, N/A, Fort Worth, TX, United States
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0271-2016Don't want to check this manually?
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