AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design
Medical device recall Z-2285-2014. 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: 24.5, 25, 25.5 & 26. 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
Serial Num 1004711311 1004721311 1004731311 1004741311 1004751311 1004761311 1004771311 1004781311 1004791311 1004801311 1004821311 1004841311 1004861311 1004881311 1004901311 1004921311 1004941311 1004961311 1004971311 1004981311…
Every code shown here, 1,991 characters
Serial Num 1004711311 1004721311 1004731311 1004741311 1004751311 1004761311 1004771311 1004781311 1004791311 1004801311 1004821311 1004841311 1004861311 1004881311 1004901311 1004921311 1004941311 1004961311 1004971311 1004981311 1004991311 1005001311 1005021311 1005041311 1005061311 1005071311 1005091311 1005111311 1005121311 1005151311 1005161311 1005171311 1005181311 1005191311 1005201311 1005211311 1005221311 1005231311 1005241311 1005251311 1005291311 1005331311 1005351311 1005521311 1005531311 1005541311 1005551311 1005561311 1005571311 1005591311 1005611311 1005651311 1005711311 1005731311 1005751311 1005771311 1005791311 1005811311 1005831311 1005841311 1005851311 1014291310 1014301310 1014311310 1014411310 1014421310 1014431310 1014451310 1014511310 1014521310 1014531310 1014541310 1014561310 1014581310 1014591310 1014601310 1014611310 1014641310 1014661310 1014671310 1014701310 1014721310 1014781310 1014801310 1014811310 1014831310 1014861310 1014881310 1014891310 1014911310 1014921310 1014931310 1014951310 1014971310 1014981310 1014991310 1015001310 1015011310 1015021310 1015031310 1015051310 1015061310 1015071310 1015081310 1015091310 1015101310 1015111310 1015131310 1015141310 1015151310 1015171310 1015181310 1015191310 1015211310 1015231310 1015251310 1015271310 1015291310 1015311310 1015331310 1015341310 1020841310 1020851310 1020861310 1020871310 1020881310 1020891310 1020901310 1020911310 1020921310 1020931310 1020941310 1020951310 1020961310 1020971310 1020981310 1020991310 1021001310 1021021310 1021031310 1021041310 1021051310 1021061310 1021071310 1021081310 1021091310 1021101310 1021111310 1021121310 1021131310 1021141310 1021151310 1021161310 1021171310 1021181310 1021191310 1021201310 1021211310 1021221310 1021231310 1021241310 1021251310 1021261310 1021271310 1021281310 1021291310 1021301310 1021311310 1021321310 1021331310 1021341310 1021351310 1021361310 1021371310 1021381310 1021391310 1021401310 1021411310 1021421310 1021431310…
FDA’s list runs to 31,779 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 31,779 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.