AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design
Medical device recall Z-2276-2014. 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: 14.5, 15.0 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
1019721311 1020201311 1025121309 1025571309 1028501309 1039911310 1040361310 1093801310 1019731311 1020211311 1025131309 1025581309 1028511309 1039921310 1040371310 1093811310 1019741311 1020221311 1025141309 1025591309 1028521309…
Every code shown here, 1,991 characters
1019721311 1020201311 1025121309 1025571309 1028501309 1039911310 1040361310 1093801310 1019731311 1020211311 1025131309 1025581309 1028511309 1039921310 1040371310 1093811310 1019741311 1020221311 1025141309 1025591309 1028521309 1039931310 1040381310 1093821310 1019751311 1020231311 1025151309 1025601309 1028531309 1039941310 1040391310 1093831310 1019761311 1020241311 1025161309 1025611309 1028541309 1039951310 1040401310 1093841310 1019771311 1020251311 1025171309 1025621309 1028551309 1039961310 1040411310 1093851310 1019781311 1020261311 1025181309 1025631309 1028561309 1039971310 1040421310 1093861310 1019791311 1020271311 1025191309 1025641309 1028571309 1039981310 1040431310 1093871310 1019801311 1020281311 1025201309 1025651309 1028581309 1039991310 1040441310 1093881310 1019811311 1020291311 1025211309 1025661309 1028591309 1040001310 1040451310 1093891310 1019821311 1020301311 1025221309 1025671309 1028601309 1040011310 1040461310 1093911310 1019831311 1020311311 1025231309 1025681309 1028611309 1040021310 1040471310 1093941310 1019841311 1020321311 1025241309 1025691309 1028621309 1040031310 1040481310 1093961310 1019851311 1020341311 1025251309 1027941309 1028631309 1040041310 1040491310 1093981310 1019861311 1020361311 1025261309 1027971309 1028641309 1040051310 1040501310 1094001310 1019871311 1020381311 1025271309 1027991309 1028651309 1040061310 1040511310 1094011310 1019881311 1020401311 1025281309 1028011309 1028671309 1040071310 1040521310 1094021310 1019891311 1020421311 1025291309 1028031309 1028691309 1040081310 1040531310 1094031310 1019901311 1020441311 1025301309 1028051309 1039601310 1040091310 1040541310 1094041310 1019911311 1020461311 1025311309 1028071309 1039621310 1040101310 1040551310 1094051310 1019921311 1020481311 1025321309 1028091309 1039631310 1040111310 1040561310 1094061310 1019931311 1020501311 1025331309 1028111309 1039641310 1040121310 1040571310 1094071310 1019941311 1020521311 1025341309 1028141309 1039651310…
FDA’s list runs to 15,531 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 15,531 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.