AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design
Medical device recall Z-2281-2014. 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: 19.5-20 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 1014621311 1014631311 1014641311 1014651311 1014661311 1014671311 1014681311 1014691311 1014701311 1014711311 1014721311 1014731311 1014741311 1014751311 1014761311 1014771311 1014781311 1014791311 1014801311 1014811311…
Every code shown here, 1,991 characters
Serial Num 1014621311 1014631311 1014641311 1014651311 1014661311 1014671311 1014681311 1014691311 1014701311 1014711311 1014721311 1014731311 1014741311 1014751311 1014761311 1014771311 1014781311 1014791311 1014801311 1014811311 1014821311 1014831311 1014841311 1014851311 1014861311 1014871311 1014881311 1014891311 1014901311 1014911311 1014921311 1014931311 1014941311 1014951311 1014961311 1014971311 1014981311 1014991311 1015001311 1015011311 1015021311 1015031311 1015041311 1015051311 1015061311 1015071311 1015081311 1015091311 1015101311 1015111311 1015121311 1015131311 1015141311 1015151311 1015161311 1015171311 1015181311 1015191311 1015201311 1015211311 1015221311 1015231311 1015241311 1015251311 1015261311 1015271311 1015281311 1015291311 1015301311 1015311311 1015321311 1015331311 1015341311 1015351311 1015361311 1015371311 1015381311 1015391311 1015401311 1015411311 1015421311 1015431311 1015441311 1015451311 1015461311 1015471311 1015481311 1015491311 1015501311 1015511311 1015521311 1015531311 1015541311 1015551311 1015561311 1015571311 1015581311 1015591311 1015601311 1015611311 1016501310 1016521310 1016541310 1016561310 1016581310 1016601310 1016621310 1016641310 1016661310 1016671310 1016681310 1016691310 1016701310 1016711310 1016721310 1016731310 1016741310 1016751310 1016761310 1016771310 1016781310 1016791310 1016801310 1016811310 1016821310 1016831310 1016841310 1016851310 1016861310 1016871310 1016881310 1016891310 1016901310 1016911310 1016921310 1016931310 1016941310 1016951310 1016961310 1016971310 1016981310 1016991310 1017001310 1017011310 1017021310 1017031310 1017041310 1017051310 1017061310 1017071310 1017081310 1017091310 1017101310 1017111310 1017121310 1017131310 1017141310 1017151310 1017161310 1017171310 1017191310 1017211310 1017231310 1017241310 1017251310 1017261310 1017271310 1017281310 1017291310 1017301310 1017311310 1017321310 1017331310 1017341310 1017351310 1017371310 1017391310 1017411310 1017431310 1017451310…
FDA’s list runs to 100,701 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 100,701 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.