AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design
Medical device recall Z-2271-2014. 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: 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0, 9.5 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
1193901309 1193981309 1194001309 1194021309 1194041309 1194061309 1194081309 1194101309 1194121309 1194141309 1194161309 1194181309 1194191309 1194201309 1194221309 1194231309 1194251309 1194321309 1194351309 1194371309 1194411309…
Every code shown here, 1,991 characters
1193901309 1193981309 1194001309 1194021309 1194041309 1194061309 1194081309 1194101309 1194121309 1194141309 1194161309 1194181309 1194191309 1194201309 1194221309 1194231309 1194251309 1194321309 1194351309 1194371309 1194411309 1194541309 1194551309 1194591309 1194611309 1194631309 1194651309 1194801309 1301391308 1301411308 1301471308 1301491308 1301511308 1301531308 1301551308 1301571308 1301591308 1301611308 1301631308 1301671308 1301751308 1301981308 1039461309 1039481309 1039521309 1039541309 1039561309 1039581309 1039601309 1039621309 1039641309 1114081309 1114411309 1114431309 1114621309 1114841309 1114861309 1114871309 1114881309 1114891309 1114921309 1297261308 1297361308 1297411308 1297491308 1297511308 1297561308 1297571308 1297581308 1297601308 1297801308 1169561309 1169601309 1169641309 1169681309 1169691309 1169721309 1169731309 1169761309 1169791309 1169801309 1169831309 1169841309 1169871309 1169891309 1169911309 1169931309 1169971309 1170011309 1170051309 1170091309 1170131309 1170171309 1170211309 1170411309 1170431309 1170451309 1170491309 1170501309 1170511309 1170551309 1170581309 1170591309 1032921309 1032941309 1033101309 1033141309 1033161309 1033181309 1033261309 1033281309 1033301309 1033341309 1033361309 1033381309 1033401309 1033441309 1033461309 1033471309 1033481309 1033491309 1033511309 1033521309 1033531309 1033541309 1033561309 1033571309 1033581309 1033591309 1033601309 1033611309 1033621309 1033631309 1033641309 1033651309 1033661309 1033671309 1033681309 1033691309 1033701309 1033721309 1033731309 1033751309 1033811309 1037161309 1037181309 1037211309 1037231309 1037251309 1037271309 1037321309 1037341309 1037351309 1037361309 1037371309 1037381309 1037391309 1037401309 1037411309 1037421309 1037431309 1037441309 1037451309 1037461309 1037471309 1037481309 1037491309 1037511309 1037531309 1037551309 1037571309 1037581309 1037591309 1037601309 1037621309 1037641309 1037651309 1037661309 1037671309 1037681309 1037691309…
FDA’s list runs to 5,543 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 5,543 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.