Recall Z-0271-2016— Alcon Research, Ltd.
Class I · Terminated
Class I FDA medical device recall by Alcon Research, Ltd., initiated 2015-09-29, terminated 2017-06-30. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Continued increase in reports of post-operative inflammation in patients who received AcrySof IQ Toric IOL..
- Recalling firm
- Alcon Research, Ltd.
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2015-09-29
- Terminated
- 2017-06-30
- Firm location
- Fort Worth, TX, United States
Product description
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.
Reason for recall
Continued increase in reports of post-operative inflammation in patients who received AcrySof IQ Toric IOL.
Data sourced from openFDA. This site is unofficial and independent of the FDA.