AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design
Medical device recall Z-2278-2014. 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: 16.5, 17.0 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
1006311309 1006881309 1031811311 1032341311 1041171312 1041681312 1042161312 1048341311 1006321309 1006891309 1031821311 1032361311 1041181312 1041701312 1042171312 1048351311 1006331309 1006901309 1031841311 1032381311 1041191312…
Every code shown here, 1,991 characters
1006311309 1006881309 1031811311 1032341311 1041171312 1041681312 1042161312 1048341311 1006321309 1006891309 1031821311 1032361311 1041181312 1041701312 1042171312 1048351311 1006331309 1006901309 1031841311 1032381311 1041191312 1041711312 1042181312 1048361311 1006341309 1006911309 1031851311 1032401311 1041201312 1041721312 1042191312 1048371311 1006351309 1006921309 1031861311 1032421311 1041211312 1041741312 1042201312 1048381311 1006361309 1006931309 1031871311 1032431311 1041221312 1041761312 1042211312 1048401311 1006371309 1006941309 1031881311 1032441311 1041231312 1041771312 1042221312 1048421311 1006381309 1006961309 1031891311 1032461311 1041241312 1041781312 1042231312 1048441311 1006391309 1006981309 1031901311 1032481311 1041251312 1041791312 1042241312 1048461311 1006401309 1007001309 1031911311 1032501311 1041261312 1041801312 1042251312 1048481311 1006411309 1007021309 1031921311 1032521311 1041271312 1041811312 1047821311 1048501311 1006421309 1007031309 1031931311 1032541311 1041281312 1041821312 1047841311 1048511311 1006431309 1007041309 1031941311 1032561311 1041291312 1041831312 1047861311 1048521311 1006441309 1007061309 1031951311 1032581311 1041301312 1041841312 1047881311 1048531311 1006451309 1007071309 1031961311 1032591311 1041311312 1041851312 1047901311 1048541311 1006471309 1007081309 1031971311 1032601311 1041321312 1041861312 1047911311 1048551311 1006491309 1007091309 1031981311 1032611311 1041331312 1041871312 1047931311 1048561311 1006511309 1007101309 1031991311 1032621311 1041341312 1041881312 1047951311 1048571311 1006561309 1007111309 1032001311 1032631311 1041351312 1041891312 1047971311 1048581311 1006571309 1007121309 1032011311 1032641311 1041361312 1041901312 1047991311 1048591311 1006581309 1007131309 1032021311 1032651311 1041371312 1041911312 1048011311 1048601311 1006601309 1007151309 1032031311 1032661311 1041381312 1041921312 1048051311 1048611311 1006621309 1007161309 1032041311 1032671311 1041391312…
FDA’s list runs to 31,712 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 31,712 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.