AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design
Medical device recall Z-2286-2014. 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: 26.5, 27, 27.5 & 28.5. 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
Serial Num 1007351309 1007361309 1007371309 1007381309 1007391309 1007411309 1007431309 1007441309 1007451309 1007461309 1007471309 1007481309 1007491309 1007501309 1007511309 1007521309 1007531309 1007541309 1007551309 1007561309…
Every code shown here, 1,991 characters
Serial Num 1007351309 1007361309 1007371309 1007381309 1007391309 1007411309 1007431309 1007441309 1007451309 1007461309 1007471309 1007481309 1007491309 1007501309 1007511309 1007521309 1007531309 1007541309 1007551309 1007561309 1007571309 1007581309 1007591309 1007601309 1007611309 1007621309 1007631309 1007641309 1007651309 1007661309 1007671309 1007681309 1007691309 1007701309 1007711309 1007721309 1007731309 1007741309 1007751309 1007761309 1007771309 1007791309 1007801309 1007811309 1007821309 1007831309 1007841309 1007851309 1007861309 1007871309 1007881309 1007891309 1007901309 1007911309 1007921309 1007931309 1007941309 1007951309 1007961309 1007971309 1007981309 1007991309 1008001309 1008011309 1008021309 1008031309 1008041309 1008051309 1008061309 1008101309 1008121309 1008141309 1008161309 1008171309 1008181309 1008191309 1008201309 1008211309 1008221309 1008231309 1008241309 1008251309 1008261309 1008271309 1008281309 1008291309 1008301309 1008311309 1008321309 1008331309 1008341309 1008361309 1008381309 1008401309 1104951312 1119291309 1119311309 1119321309 1119331309 1119341309 1119351309 1119361309 1119371309 1119381309 1119391309 1119401309 1119411309 1119421309 1119431309 1119451309 1119461309 1119471309 1119481309 1119491309 1119501309 1119511309 1119521309 1119531309 1119541309 1119551309 1119561309 1119571309 1119581309 1119591309 1119601309 1119611309 1119621309 1119631309 1119641309 1119651309 1119661309 1119671309 1119681309 1119691309 1119701309 1119711309 1119721309 1119731309 1119741309 1119751309 1119771309 1119811309 1119831309 1119851309 1119871309 1119901309 1119921309 1119931309 1119941309 1119951309 1119971309 1119991309 1120001309 1120021309 1120041309 1120061309 1120081309 1120101309 1120121309 1120141309 1120161309 1120181309 1120201309 1120221309 1120251309 1120261309 1120271309 1120281309 1120331309 1120361309 1120371309 1120381309 1120391309 1120411309 1120421309 1217951310 1217971310 1217991310 1218011310 1218031310…
FDA’s list runs to 10,284 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 10,284 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.