Expansion of previous recall of AcrySof IQ ReSTOR and AcrySof IQ ReSTOR Toric IOL
Medical device recall Z-0271-2016. Published in FDA’s Enforcement Report on Dec 2, 2015.
- FDA Class I
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Dec 2, 2015. Copied from openFDA on Oct 20, 2026.
- Class I FDA’s most serious class (needs attention)
- Terminated its status, in FDA’s file
- Not named no state, in where it went
- 43,651 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class I, the most serious of FDA’s three classes.
“Dangerous or defective products that predictably could cause serious health problems or death. Examples include: food found to contain botulinum toxin, food with undeclared allergens, a label mix-up on a lifesaving drug, or a defective artificial heart valve.”
openFDA, in plain words, its enforcement report fields.
“Class I is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.”
FDA’s rule, 21 CFR 7.3(m)(1), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Continued increase in reports of post-operative inflammation in patients who received AcrySof IQ Toric IOL.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are 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.
43,651 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,998 characters
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 12241341 12241342 12241343 12241344 12241345 12241346 12243953 12245144 12245145 12245163 12245164 12245165 12245166 12245167 12245168 12245169 12245170 12245171 12245172 12246221 12247472 12247473 12247474 12247475 12247476 12249098 12249099 12249100 12249101 12250139 12250944 12251348 12251349 12254704 12258373 12261857 12261858 12261859 12261860 12261861 12261862 12261863 12261864 12261865 12267813 12267814 12267815 12267816 12267817 12267818 12267819 12269093 12269094 12269095 12269096 12272159 12272160 12272161 12272162 12272163 12272164 12273173 12273174 12273175 12273176 12273177 12273178 12273179 12273180 12273181 12273182 12273183 12274561 12274562 12275464 12275465 12275466 12275467 12275468 12275469 12275470 12275471 12276613 12276614 12276615 12280534 12280535 12280536 12280537 12280538 12280539 12280540 12280541 12280542 12280543 12280544 12280545 12285570 12285571 12285572 12285573 12285574 12285575 12285576 12288202 12290298 12290362 12290363 12290364 12290365 12290366 12290367 12290368 12290369 12290370 12302748 12302749 12302750 12302751 12302752 12302753 12302754…
FDA’s list runs to 6,488 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
International Only Distribution -- Japan.
These words name no state.
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Sep 29, 2015.
- FDA classified it on Nov 25, 2015.
- FDA’s Enforcement Report published it on Dec 2, 2015.
- FDA terminated it on Jun 30, 2017.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Alcon Research, Ltd., of Fort Worth, TX.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 6,488 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.