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.
Reported: December 2, 2015 Initiated: September 29, 2015 #Z-0271-2016
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.
Details
- Recalling Firm
- Alcon Research, Ltd.
- Units Affected
- 43,651 units
- Distribution
- International Only Distribution -- Japan.
- Location
- Fort Worth, TX
Frequently Asked Questions
What product 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.. Recalled by Alcon Research, Ltd.. Units affected: 43,651 units.
Why was this product recalled? ▼
Continued increase in reports of post-operative inflammation in patients who received AcrySof IQ Toric IOL.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 2, 2015. Severity: Critical. Recall number: Z-0271-2016.
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