Expansion of previous recall of AcrySof IQ ReSTOR and AcrySof IQ… — Class I medical device recall Z-0271-2016
Terminated recall by Alcon Research, Ltd., reported 2015-12-02. Continued increase in reports of post-operative inflammation in patients who received AcrySof IQ Toric IOL.
| Recall number | Z-0271-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Alcon Research, Ltd., Fort Worth, TX, United States |
| Recall initiated | 2015-09-29 |
| Classified | 2015-11-25 |
| Reported by FDA | 2015-12-02 |
| Terminated | 2017-06-30 |
| Countries outside the US | JP |
| Quantity | 43,651 units |
| Model numbers | SN6AT6, SN6AT7, SN6AT8, SN6AT9 |
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 for recall
Continued increase in reports of post-operative inflammation in patients who received AcrySof IQ Toric IOL.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0271-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.