AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design
Medical device recall Z-2283-2014. 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: 21.5-22.5 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
Serial Num 1001951310 1001961310 1001971310 1001981310 1001991310 1002001310 1002011310 1002021310 1002031310 1002041310 1002051310 1002061310 1002071310 1002081310 1002091310 1002101310 1002111310 1002121310 1002131310 1002141310…
Every code shown here, 1,991 characters
Serial Num 1001951310 1001961310 1001971310 1001981310 1001991310 1002001310 1002011310 1002021310 1002031310 1002041310 1002051310 1002061310 1002071310 1002081310 1002091310 1002101310 1002111310 1002121310 1002131310 1002141310 1002151310 1002161310 1002171310 1002181310 1002191310 1002201310 1002221310 1002241310 1002281310 1002301310 1002321310 1002341310 1002361310 1002381310 1002391310 1002411310 1002431310 1002451310 1002471310 1002491310 1002511310 1002531310 1002551310 1002571310 1002591310 1002611310 1002621310 1002631310 1002641310 1002651310 1002661310 1002671310 1002681310 1002691310 1002701310 1002711310 1002721310 1002731310 1002741310 1002751310 1002761310 1002771310 1002781310 1002791310 1002801310 1002811310 1002821310 1002831310 1002841310 1002851310 1002861310 1002871310 1002881310 1002891310 1002901310 1002911310 1002921310 1002931310 1002941310 1002951310 1002961310 1002971310 1002981310 1002991310 1003001310 1003011310 1003021310 1003031310 1003041310 1003051310 1003061310 1003071310 1003081310 1003091310 1003101310 1003111310 1003121310 1003131310 1003141310 1003151310 1003161310 1003171310 1003181310 1003191310 1003201310 1003211310 1003221310 1003231310 1003241310 1003251310 1003261310 1003271310 1003281310 1003291310 1003301310 1003311310 1003321310 1003331310 1003341310 1003351310 1003361310 1003371310 1003381310 1003391310 1003401310 1003411310 1003421310 1003431310 1003441310 1003451310 1003461310 1003471310 1003481310 1003491310 1003501310 1003511310 1003521310 1003531310 1003541310 1003551310 1003561310 1003571310 1003581310 1003591310 1003601310 1003611310 1003621310 1003631310 1003641310 1003651310 1003661310 1003671310 1003681310 1003691310 1003701310 1003711310 1003721310 1003731310 1003741310 1003751310 1003761310 1003771310 1003781310 1003791310 1003801310 1003811310 1003821310 1003831310 1003841310 1003851310 1003861310 1003871310 1003881310 1003891310 1003901310 1003911310 1003921310 1003931310 1003941310 1003951310…
FDA’s list runs to 157,270 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 157,270 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.