AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design
Medical device recall Z-2282-2014. 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: 20.5-21 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 1000541311 1000561311 1000581311 1000601311 1000621311 1000641311 1000661311 1000681311 1000701311 1000721311 1000741311 1000761311 1000781311 1000801311 1000821311 1000841311 1000861311 1000881311 1000891311 1000901311…
Every code shown here, 1,991 characters
Serial Num 1000541311 1000561311 1000581311 1000601311 1000621311 1000641311 1000661311 1000681311 1000701311 1000721311 1000741311 1000761311 1000781311 1000801311 1000821311 1000841311 1000861311 1000881311 1000891311 1000901311 1000911311 1000921311 1000931311 1000941311 1000951311 1000961311 1000971311 1000981311 1000991311 1001001311 1001011311 1001021311 1001031311 1001041311 1001051311 1001061311 1001071311 1001081311 1001091311 1001101311 1001111311 1001121311 1001131311 1001141311 1001151311 1001161311 1001171311 1001181311 1001191311 1001201311 1001211309 1001211311 1001221311 1001231309 1001231311 1001241311 1001251309 1001251311 1001261311 1001271309 1001271311 1001281311 1001291309 1001291311 1001301311 1001311309 1001311311 1001321311 1001331311 1001341311 1001351311 1001361311 1001371311 1001381311 1001391311 1001401309 1001401311 1001411309 1001411311 1001421311 1001431309 1001431311 1001441311 1001451309 1001451311 1001461311 1001471309 1001471311 1001481309 1001481311 1001491309 1001491311 1001501309 1001501311 1001511311 1001521309 1001521311 1001531309 1001531311 1001541309 1001541311 1001551309 1001551311 1001561309 1001561311 1001571311 1001581309 1001581311 1001591311 1001601309 1001601311 1001611311 1001621309 1001621311 1001631311 1001641309 1001641311 1001651311 1001661309 1001671311 1001681309 1001691311 1001711311 1001721309 1001731311 1001741309 1001751311 1001761309 1001771311 1001781309 1001791311 1001801309 1001811311 1001821309 1001821311 1001831311 1001841309 1001841311 1001851311 1001861309 1001861311 1001871311 1001881309 1001881311 1001891311 1001901309 1001901311 1001911311 1001921311 1001931311 1001941311 1001951311 1001961311 1001971311 1001981311 1001991311 1002001311 1002011311 1002021311 1002031311 1002041311 1002051311 1002061311 1002071311 1002081311 1002091311 1002101311 1002111311 1002121309 1002121311 1002131311 1002141309 1002141311 1002151311 1002161309 1002161311 1002171311 1002181309 1002181311 1002191311…
FDA’s list runs to 120,645 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 120,645 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.