AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design
Medical device recall Z-2280-2014. 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: 18.5-19.0 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
1001141312 1001151312 1001161312 1001171312 1001181312 1001191312 1001201312 1001211312 1001221312 1001231312 1001241312 1001251312 1001261312 1001271312 1001291312 1001301312 1001311312 1001321312 1001331312 1001341312 1001351312…
Every code shown here, 1,991 characters
1001141312 1001151312 1001161312 1001171312 1001181312 1001191312 1001201312 1001211312 1001221312 1001231312 1001241312 1001251312 1001261312 1001271312 1001291312 1001301312 1001311312 1001321312 1001331312 1001341312 1001351312 1001361312 1001371312 1001381312 1001391312 1001401312 1001411312 1001421312 1001431312 1001441312 1001451312 1001461312 1001471312 1001481312 1001491312 1001501312 1001511312 1001521312 1001531312 1001541312 1001551312 1001571312 1001591312 1001611312 1001631312 1001651312 1001671312 1001691312 1001711312 1001731312 1001751312 1001771312 1001811312 1001831312 1001851312 1001871312 1001891312 1001911312 1001931312 1001951312 1001971312 1001991312 1002001312 1002021312 1002041312 1002061312 1002081312 1002101312 1002121312 1002131312 1002141312 1002151312 1002161312 1002171312 1002181312 1002201312 1002221312 1002231312 1005251309 1005261309 1005271309 1005281309 1005291309 1005301309 1005321309 1005341309 1005361309 1005381309 1005401309 1005421309 1005431309 1005441309 1005451309 1005461309 1005471309 1005491309 1005501309 1005511309 1005521309 1005531309 1005551309 1005561309 1005571309 1005581309 1005591309 1005601309 1005611309 1005621309 1005631309 1005641309 1005651309 1005671309 1005681309 1005691309 1005701309 1005711309 1005721309 1005731309 1005751309 1005771309 1005791309 1005811309 1005831309 1005851309 1005871309 1005891309 1005911309 1005931309 1005951309 1005971309 1005991309 1006011309 1006031309 1006051309 1006061309 1006071309 1006081309 1006091309 1006101309 1006111309 1006121309 1006131309 1006151309 1006171309 1006211309 1006231309 1006241309 1006251309 1006261309 1006271309 1006281309 1006291309 1006301309 1009131311 1009141311 1009151311 1009161311 1009171311 1009181311 1009191311 1009201311 1009211311 1009221311 1009231311 1009241311 1009251311 1009261311 1009271311 1009281311 1009291311 1009301311 1009321311 1009331311 1009341311 1009351311 1009361311 1009371311 1009381311 1009391311 1009401311 1009411311…
FDA’s list runs to 68,663 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 68,663 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.