AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design
Medical device recall Z-2287-2014. 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: 29, 29.5 & 30. 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 1101821309 1101831309 1101841309 1101861309 1101881309 1101901309 1101921309 1101941309 1101981309 1101991309 1102001309 1102011309 1102031309 1102051309 1102071309 1102091309 1102111309 1102131309 1102201309 1102211309…
Every code shown here, 1,991 characters
Serial Num 1101821309 1101831309 1101841309 1101861309 1101881309 1101901309 1101921309 1101941309 1101981309 1101991309 1102001309 1102011309 1102031309 1102051309 1102071309 1102091309 1102111309 1102131309 1102201309 1102211309 1102221309 1102231309 1102241309 1102261309 1102271309 1102291309 1102301309 1102311309 1102321309 1102331309 1102351309 1102371309 1102381309 1102391309 1102401309 1102411309 1102431309 1102461309 1102481309 1102501309 1102551309 1102621309 1102641309 1102651309 1102661309 1102681309 1102811309 1102831309 1102851309 1102871309 1102911309 1102941309 1289831308 1289841308 1289851308 1289861308 1289871308 1289881308 1289891308 1289901308 1289911308 1289921308 1289931308 1289941308 1289961308 1290001308 1290021308 1290041308 1290061308 1290071308 1290081308 1290091308 1290101308 1290111308 1290121308 1290141308 1290161308 1290171308 1290181308 1290191308 1290201308 1290211308 1290231308 1290251308 1290271308 1290281308 1290291308 1290311308 1290321308 1290331308 1290341308 1290351308 1290361308 1290371308 1290381308 1039861309 1039881309 1039901309 1039961309 1039981309 1040011309 1040021309 1040041309 1040121309 1040151309 1040161309 1040171309 1040181309 1040191309 1040201309 1040211309 1040231309 1040251309 1040271309 1040291309 1040311309 1040331309 1040351309 1040371309 1040391309 1040471309 1040501309 1040551309 1040571309 1040591309 1040671309 1040711309 1040771309 1048531309 1048541309 1048551309 1048561309 1048571309 1048591309 1048601309 1048611309 1048621309 1048631309 1048641309 1048661309 1048671309 1048681309 1048691309 1048701309 1048711309 1048721309 1048731309 1048741309 1048751309 1048761309 1048771309 1048781309 1048801309 1048811309 1048841309 1048911309 1048921309 1048931309 1048941309 1048951309 1048971309 1048981309 1048991309 1049001309 1049021309 1049031309 1049041309 1049051309 1049071309 1049101309 1049121309 1049141309 1049161309 1049181309 1049201309 1049211309 1049221309 1049251309 1049271309 1049291309…
FDA’s list runs to 2,529 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 2,529 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.