AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design
Medical device recall Z-2279-2014. 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: 17.5, 18.0 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
1004271312 1004831312 1012421311 1013091311 1027651310 1028131310 1031861309 1032381309 1004281312 1004841312 1012521311 1013101311 1027661310 1028141310 1031871309 1032401309 1004291312 1004851312 1012541311 1013121311 1027671310…
Every code shown here, 1,991 characters
1004271312 1004831312 1012421311 1013091311 1027651310 1028131310 1031861309 1032381309 1004281312 1004841312 1012521311 1013101311 1027661310 1028141310 1031871309 1032401309 1004291312 1004851312 1012541311 1013121311 1027671310 1028151310 1031881309 1032411309 1004301312 1004861312 1012601311 1013141311 1027691310 1028161310 1031891309 1032421309 1004311312 1004871312 1012621311 1013161311 1027701310 1028171310 1031901309 1032431309 1004321312 1004881312 1012641311 1013181311 1027711310 1028181310 1031921309 1032441309 1004331312 1004891312 1012661311 1013201311 1027721310 1028191310 1031941309 1032451309 1004341312 1004901312 1012681311 1013221311 1027731310 1028201310 1031951309 1032461309 1004351312 1004911312 1012701311 1013241311 1027741310 1028211310 1031961309 1032471309 1004361312 1004921312 1012711311 1013261311 1027751310 1028221310 1031981309 1032481309 1004371312 1004931312 1012721311 1013281311 1027761310 1028231310 1032001309 1032491309 1004381312 1004941312 1012731311 1013291311 1027771310 1028241310 1032021309 1032501309 1004391312 1004951312 1012741311 1013311311 1027781310 1028251310 1032041309 1032521309 1004401312 1004961312 1012751311 1013331311 1027791310 1028261310 1032051309 1032531309 1004411312 1004971312 1012761311 1013341311 1027801310 1028271310 1032061309 1032551309 1004421312 1004981312 1012771311 1013351311 1027811310 1028281310 1032071309 1032561309 1004431312 1004991312 1012781311 1013361311 1027821310 1028291310 1032081309 1032571309 1004441312 1005001312 1012791311 1013371311 1027831310 1028301310 1032091309 1032591309 1004451312 1005011312 1012801311 1013381311 1027841310 1028311310 1032101309 1032601309 1004461312 1005021312 1012821311 1013391311 1027851310 1028321310 1032111309 1032611309 1004471312 1005031312 1012841311 1013401311 1027861310 1028331310 1032121309 1032621309 1004491312 1005041312 1012851311 1013411311 1027871310 1028341310 1032131309 1032661309 1004511312 1005051312 1012861311 1013421311 1027881310…
FDA’s list runs to 48,270 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 48,270 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.