AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design
Medical device recall Z-2273-2014. Published in FDA’s Enforcement Report on Aug 27, 2014.
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 Aug 27, 2014. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 1 state named
- 77,055 IOLs in total 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 II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Units may be labeled with the incorrect diopter power.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 11.0 and 11.5 Product Usage: AMO TECNIS CL monofocal foldable IOLs with OptiEdge design are ultraviolet-absorbing posterior chamber intraocular lenses which compensate for corneal spherical aberrations. TECNIS CL Silicone Intraocular Lenses are indicated for primary implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the capsular bag.
77,055 IOLs in total, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
1177211309 1228981309 1177341309 1229001309 1177361309 1229021309 1177381309 1229041309 1177391309 1229061309 1177401309 1229111309 1177411309 1229191309 1177421309 1229211309 1177431309 1229221309 1177451309 1229241309 1177601309…
Every code shown here, 1,991 characters
1177211309 1228981309 1177341309 1229001309 1177361309 1229021309 1177381309 1229041309 1177391309 1229061309 1177401309 1229111309 1177411309 1229191309 1177421309 1229211309 1177431309 1229221309 1177451309 1229241309 1177601309 1229261309 1177621309 1229271309 1177681309 1229281309 1177751309 1229291309 1177771309 1229301309 1177791309 1229311309 1177811309 1229321309 1177821309 1229331309 1177831309 1229341309 1177841309 1229351309 1177861309 1229381309 1177881309 1229401309 1177901309 1229501309 1177921309 1229521309 1178041309 1229541309 1178061309 1229551309 1178081309 1229561309 1178101309 1229571309 1178121309 1229581309 1178141309 1229591309 1178151309 1229601309 1178161309 1229611309 1178181309 1229621309 1178201309 1229631309 1178211309 1229651309 1178221309 1229671309 1228801309 1229681309 1228821309 1229691309 1228851309 1229701309 1228861309 1229721309 1228881309 1229741309 1228901309 1229761309 1228921309 1229771309 1228941309 1229781309 1228961309 1229811309 1229831309 1229841309 1229871309 1229881309 1177291309 1228871309 1228891309 1228911309 1229451309 1229511309 1107621309 1107721309 1107741309 1107801309 1108041309 1215161310 1224661309 1225081309 1293581308 1293621308 1294031308 1294091308 1294111308 1294251308 1107431309 1108051309 1215071310 1224861309 1293691308 1107441309 1108061309 1215091310 1224871309 1293751308 1107451309 1108071309 1215111310 1224881309 1293761308 1107471309 1108081309 1215131310 1224891309 1293771308 1107481309 1108091309 1215151310 1224911309 1293781308 1107491309 1108101309 1215171310 1224921309 1293791308 1107511309 1108111309 1215191310 1224931309 1293801308 1107521309 1108131309 1215211310 1224941309 1293811308 1107531309 1108151309 1215221310 1224951309 1293821308 1107551309 1108161309 1215241310 1224961309 1293831308 1107561309 1108171309 1215251310 1224971309 1293841308 1107571309 1108181309 1215261310 1224981309 1293851308 1107591309 1108201309 1215271310 1225001309 1293871308 1107601309 1108211309…
FDA’s list runs to 3,761 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.
Worldwide Distribution - Nationwide (USA and Puerto Rico), and foreign: Latin America, Asia Pacific, Canada, Europe, Africa and Middle East, and Japan.
The states and territories these words name
- Puerto Rico
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
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 May 13, 2014.
- FDA classified it on Aug 19, 2014.
- FDA’s Enforcement Report published it on Aug 27, 2014.
- FDA terminated it on May 18, 2017.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- AMO Puerto Rico Manufacturing, Inc., of Anasco, PR.
- 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 3,761 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
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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.