AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design
Medical device recall Z-2284-2014. 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.
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: 23, 23.5 & 24. 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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Num 1006151310 1006191310 1006211310 1006231310 1006251310 1006271310 1006291310 1006311310 1006331310 1006351310 1006371310 1006371312 1006391310 1006391312 1006411310 1006411312 1006431310 1006431312 1006451310 1006451312…
Every code shown here, 1,991 characters
Serial Num 1006151310 1006191310 1006211310 1006231310 1006251310 1006271310 1006291310 1006311310 1006331310 1006351310 1006371310 1006371312 1006391310 1006391312 1006411310 1006411312 1006431310 1006431312 1006451310 1006451312 1006471310 1006471312 1006481310 1006491310 1006491312 1006501310 1006511310 1006511312 1006521310 1006531310 1006531312 1006541310 1006551310 1006561310 1006571310 1006591310 1006601310 1006611310 1006621310 1006631310 1006641310 1006651310 1006661310 1006671310 1006681310 1006691310 1006701310 1006711310 1006721310 1006731310 1006741310 1006751310 1006761310 1006771310 1006781310 1006791310 1006801310 1006811310 1006821310 1006831310 1006841310 1006851310 1006871310 1006881310 1006891310 1006901310 1006911310 1006921310 1006931310 1006931312 1006941310 1006951310 1006951312 1006961310 1006971310 1006981310 1007001310 1007221312 1007241312 1007261312 1007281312 1007301312 1007321312 1007341312 1007351312 1007361312 1007371312 1007381312 1007401312 1007421312 1007441312 1008211310 1008231310 1008351310 1008371310 1008391310 1008411310 1008431310 1008451310 1008471310 1008491310 1008511310 1008531310 1008541310 1008551310 1008561310 1008571310 1008581310 1008591310 1008601310 1008611310 1008621310 1008631310 1008641310 1008651310 1008661310 1008681310 1008701310 1008721310 1008741310 1008761310 1008781310 1008801310 1008821310 1008841310 1008861310 1008881310 1009001310 1009021310 1009041310 1009311309 1009391309 1009411309 1009431309 1009451309 1009521309 1009541309 1009551309 1009571309 1009591309 1009611309 1009631309 1009641309 1009651309 1009661309 1009671309 1009681309 1009701309 1009721309 1009771309 1009791309 1009811309 1009831309 1009851309 1009871309 1009891309 1009911309 1009941309 1009961309 1010011309 1010021309 1010031309 1010041309 1010051309 1010061309 1010071309 1010081309 1010091309 1010101309 1010111309 1010131309 1010151309 1010171309 1010181309 1010201309 1010211309 1010221309 1010231309 1010241309 1010251309…
FDA’s list runs to 86,472 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 86,472 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
-
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.