AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design
Medical device recall Z-2275-2014. 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: 13.0, 13.5, 14.0 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
1030801310 1031311310 1112971309 1113531309 1213831310 1214371310 1262641310 1290511308 1030811310 1031321310 1112991309 1113541309 1213861310 1214381310 1262661310 1290521308 1030821310 1031331310 1113011309 1113551309 1213881310…
Every code shown here, 1,991 characters
1030801310 1031311310 1112971309 1113531309 1213831310 1214371310 1262641310 1290511308 1030811310 1031321310 1112991309 1113541309 1213861310 1214381310 1262661310 1290521308 1030821310 1031331310 1113011309 1113551309 1213881310 1214401310 1262721310 1290531308 1030831310 1031351310 1113031309 1113561309 1213891310 1214421310 1262731310 1290541308 1030841310 1031361310 1113051309 1113571309 1213911310 1214441310 1262751310 1290551308 1030861310 1031371310 1113071309 1113581309 1213921310 1214461310 1262771310 1290561308 1030871310 1031381310 1113091309 1113601309 1213941310 1214481310 1262781310 1290571308 1030881310 1031391310 1113101309 1113621309 1213951310 1214491310 1262791310 1290581308 1030891310 1031401310 1113111309 1113661309 1213961310 1214501310 1262801310 1290591308 1030901310 1031411310 1113121309 1113681309 1213971310 1214511310 1262811310 1290601308 1030911310 1031421310 1113131309 1113701309 1213981310 1214521310 1262821310 1290611308 1030921310 1031431310 1113141309 1113711309 1213991310 1214531310 1262831310 1290621308 1030931310 1031451310 1113151309 1113721309 1214001310 1214541310 1262851310 1290631308 1030941310 1031471310 1113161309 1113731309 1214011310 1214561310 1262871310 1290641308 1030951310 1031491310 1113171309 1113741309 1214021310 1214571310 1262891310 1290651308 1030961310 1031511310 1113181309 1113761309 1214031310 1214581310 1262911310 1290661308 1030971310 1031521310 1113191309 1113781309 1214041310 1214591310 1262931310 1290671308 1030981310 1031531310 1113201309 1113791309 1214051310 1214601310 1262951310 1290681308 1030991310 1031541310 1113211309 1113801309 1214061310 1214611310 1262971310 1290701308 1031001310 1031551310 1113221309 1113811309 1214071310 1214621310 1262991310 1290721308 1031011310 1031561310 1113231309 1113821309 1214081310 1214641310 1263011310 1290741308 1031021310 1031571310 1113241309 1113831309 1214101310 1214661310 1263031310 1290761308 1031041310 1031581310 1113251309 1113841309 1214121310…
FDA’s list runs to 14,552 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 14,552 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.