AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design
Medical device recall Z-2272-2014. 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: 10.0 and 10.5 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
1003871311 1042751309 1166801309 1003911311 1042761309 1166811309 1003931311 1042771309 1166821309 1003951311 1042781309 1166831309 1003971311 1042801309 1166841309 1003991311 1042821309 1166851309 1004011311 1042841309 1166861309…
Every code shown here, 1,991 characters
1003871311 1042751309 1166801309 1003911311 1042761309 1166811309 1003931311 1042771309 1166821309 1003951311 1042781309 1166831309 1003971311 1042801309 1166841309 1003991311 1042821309 1166851309 1004011311 1042841309 1166861309 1004501311 1042861309 1166871309 1004521311 1042881309 1166881309 1004561311 1042901309 1166891309 1004581311 1042941309 1166901309 1004601311 1042961309 1166911309 1004621311 1043061309 1166921309 1004631311 1043081309 1166941309 1004641311 1043121309 1166961309 1004661311 1043141309 1166971309 1004671311 1043161309 1166981309 1004681311 1166391309 1166991309 1042091309 1166431309 1167001309 1042111309 1166441309 1167021309 1042191309 1166451309 1167041309 1042271309 1166471309 1167051309 1042291309 1166481309 1167061309 1042311309 1166511309 1167081309 1042331309 1166531309 1167101309 1042351309 1166561309 1167111309 1042391309 1166581309 1167131309 1042481309 1166601309 1167141309 1042571309 1166621309 1167151309 1042581309 1166631309 1167161309 1042591309 1166641309 1167171309 1042601309 1166661309 1167181309 1042611309 1166671309 1167201309 1042621309 1166681309 1167221309 1042631309 1166691309 1167241309 1042641309 1166701309 1167251309 1042651309 1166711309 1167261309 1042671309 1166721309 1167271309 1042681309 1166731309 1167281309 1042691309 1166741309 1167291309 1042701309 1166751309 1167301309 1042711309 1166761309 1167311309 1042721309 1166771309 1167321309 1042731309 1166781309 1167331309 1042741309 1166791309 1167351309 1167371309 1167391309 1167411309 1167431309 1167441309 1167451309 1167461309 1013301309 1014161309 1013311309 1014171309 1013331309 1014191309 1013351309 1014231309 1013391309 1014251309 1013411309 1014261309 1013431309 1014281309 1013451309 1014301309 1013511309 1014321309 1013531309 1014341309 1013551309 1014351309 1013561309 1083721309 1013571309 1083731309 1013581309 1083751309 1013601309 1083851309 1013611309 1083871309 1013621309 1083881309 1013641309 1083891309 1013661309 1083901309 1013701309…
FDA’s list runs to 3,024 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 3,024 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.