AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design
Medical device recall Z-2277-2014. 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: 15.5, 16.0 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
1014361309 1014851309 1022981309 1023501309 1023971309 1097131310 1124801310 1125311310 1014371309 1014861309 1023001309 1023511309 1023981309 1097141310 1124811310 1125331310 1014381309 1014871309 1023011309 1023521309 1023991309…
Every code shown here, 1,991 characters
1014361309 1014851309 1022981309 1023501309 1023971309 1097131310 1124801310 1125311310 1014371309 1014861309 1023001309 1023511309 1023981309 1097141310 1124811310 1125331310 1014381309 1014871309 1023011309 1023521309 1023991309 1097161310 1124821310 1125351310 1014391309 1014881309 1023021309 1023531309 1024011309 1097181310 1124831310 1125361310 1014401309 1014891309 1023031309 1023541309 1024031309 1097201310 1124841310 1125371310 1014411309 1014901309 1023041309 1023551309 1096541310 1097221310 1124851310 1125381310 1014421309 1014911309 1023051309 1023561309 1096561310 1097241310 1124861310 1125391310 1014431309 1014921309 1023061309 1023571309 1096581310 1097251310 1124871310 1125401310 1014441309 1014931309 1023071309 1023581309 1096591310 1097261310 1124881310 1125411310 1014451309 1014941309 1023081309 1023591309 1096601310 1097271310 1124891310 1125421310 1014461309 1014951309 1023111309 1023601309 1096611310 1097281310 1124901310 1125431310 1014471309 1014961309 1023131309 1023611309 1096621310 1097301310 1124911310 1125441310 1014481309 1014971309 1023151309 1023621309 1096631310 1097321310 1124921310 1125451310 1014491309 1014981309 1023171309 1023631309 1096641310 1097341310 1124931310 1125471310 1014501309 1014991309 1023191309 1023641309 1096651310 1097361310 1124941310 1125491310 1014511309 1015001309 1023201309 1023651309 1096661310 1097381310 1124951310 1125501310 1014521309 1015011309 1023211309 1023661309 1096671310 1097401310 1124961310 1125511310 1014531309 1015021309 1023221309 1023671309 1096681310 1097441310 1124971310 1125521310 1014541309 1015031309 1023231309 1023681309 1096691310 1097461310 1124981310 1125541310 1014551309 1015041309 1023241309 1023691309 1096701310 1097481310 1124991310 1125561310 1014561309 1015051309 1023251309 1023701309 1096711310 1097501310 1125001310 1125581310 1014571309 1015061309 1023261309 1023711309 1096721310 1097521310 1125011310 1125601310 1014581309 1015071309 1023271309 1023721309 1096731310…
FDA’s list runs to 21,141 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 21,141 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.