TECNIS 1-Piece IOL with the TECNIS iTec Preloaded Delivery System
Medical device recall Z-2861-2016. Published in FDA’s Enforcement Report on Sep 28, 2016.
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 Sep 28, 2016. 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
- 217 units 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?
Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked prior to release and this may result in the release of mislabeled IOLs.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
TECNIS 1-Piece IOL with the TECNIS iTec Preloaded Delivery System, Model No. PCB00 The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens is intended to be placed in the capsular bag.
217 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial No. 7138841403 2648831412 2648971412 2649011412 2649071412 2649101412 2649181412 2649221412 2649241412 2649261412 2649281412 2649301412 7138301403 7138311403 7138321403 7138331403 7138341403 7138351403 7138361403 7138371403…
Every code shown here, 1,991 characters
Serial No. 7138841403 2648831412 2648971412 2649011412 2649071412 2649101412 2649181412 2649221412 2649241412 2649261412 2649281412 2649301412 7138301403 7138311403 7138321403 7138331403 7138341403 7138351403 7138361403 7138371403 7138381403 7138391403 7138401403 7138411403 7138431403 7138441403 7138451403 7138461403 7138471403 7138481403 7138491403 7138501403 7138511403 7138521403 7138531403 7138541403 7138551403 7138561403 7138571403 7138581403 7138591403 7138601403 7138611403 7138621403 7138631403 7138641403 7138651403 7138661403 7138671403 7138681403 7138691403 7138701403 7138711403 7138721403 7138731403 7138741403 7138751403 7138761403 7138771403 7138781403 7138791403 7138801403 7138811403 7138821403 7138831403 7138851403 7138881403 7138891403 7138901403 7138911403 7138921403 7138941403 7138951403 7138961403 7138971403 7138981403 7138991403 7139001403 7139011403 7139021403 7139031403 7139041403 7139051403 7139061403 7139071403 7139081403 7139091403 7139101403 7139111403 7139121403 7139131403 7139141403 2648751412 2648761412 2648771412 2648781412 2648791412 2648801412 2648811412 2648821412 2648841412 2648851412 2648861412 2648871412 2648881412 2648891412 2648901412 2648911412 2648921412 2648931412 2648941412 2648951412 2648961412 2648981412 2648991412 2649001412 2649021412 2649031412 2649041412 2649061412 2649081412 2649091412 2649111412 2649121412 2649131412 2649141412 2649151412 2649161412 2649171412 2649191412 2649201412 2649211412 2649231412 2649251412 2649271412 2649291412 2649311412 2397761605 2397981605 3125171501 3125181501 7731731310 7731741310 7731751310 7731761310 7731771310 7731781310 7731791310 7731801310 7731811310 7731821310 7731831310 7731841310 7731851310 7731861310 7731871310 7731881310 7731891310 7731901310 7731911310 7731921310 7731931310 7731941310 7731951310 7731961310 7731971310 7731981310 7731991310 7732001310 7732011310 7732021310 7732031310 7732041310 7732051310 7732061310 7732071310 7732081310 7732091310 7732101310 7732121310…
FDA’s list runs to 2,397 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 - US nationwide, PR, and Internationally to Canada, Latin America, Europe, Africa, Middle East, and Asia Pacific.
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 Aug 26, 2016.
- FDA classified it on Sep 21, 2016.
- FDA’s Enforcement Report published it on Sep 28, 2016.
- FDA terminated it on Dec 23, 2016.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Abbott Medical Optics Inc. (AMO), of Santa Ana, CA.
- 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 2,397 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.