FDA Device recall Z-0271-2016
Expansion of previous recall of AcrySof IQ ReSTOR and AcrySof IQ ReSTOR Toric IOL
- FDA Device
- Class I
- terminated
- Published 2015-12-02
On 2015-12-02 the FDA classified a Class I recall of Expansion of previous recall of AcrySof IQ ReSTOR and AcrySof IQ ReSTOR Toric IOL by Alcon Research, citing continued increase in reports of post-operative inflammation in patients who received AcrySof IQ Toric IOL.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0271-2016 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2015-09-29 |
| Published | 2015-12-02 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Alcon Research |
| Distribution | n/a |
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.
Identifiers
| code_info | 12156526 12156527 12156528 12156529 12156530 12156531 12158162 12158163 12158164 12158165 12158166 12161289…12156526 12156527 12156528 12156529 12156530 12156531 12158162 12158163 12158164 12158165 12158166 12161289 12161290 12161291 12161292 12161293 12161294 12161295 12161296 12161297 12161298 12161299 12165173 12165174 12165175 12165176 12165179 12165187 12165188 12165192 12165193 12199362 12199363 12199365 12199367 12205570 12205881 12205882 12205883 12205884 12205885 12205886 12205887 12205888 12205889 12205890 12205891 12208850 12208851 12208852 12208853 12208854 12208855 12208856 12208857 12208858 12208859 12208860 12208861 12208862 12216598 12220884 12220956 12220957 12223717 12224422 12224753 12224754 12224755 12224756 12224757 12225701 12230266 12230895 12230896 12230897 12231907 12233505 12233506 12233507 12235083 12238380 12238381 12238382 12238383 12238384 12238385 12238386 12238387 12238388 12238389 12238390 12238391 12238397 12238398 12241033 12241034 12241338 12241339 12241340 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0271-2016%22
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