CLASS II Device recall · Reported 28 Sep 2016 · FDA Enforcement Report
Tecnis 1-Piece Iol with the Tecnis iTec Preloaded Delivery System recalled
Abbott Medical Optics Inc. (AMO) is recalling Tecnis 1-Piece Iol with the Tecnis iTec Preloaded Delivery System, distributed nationwide in the US. The recall was initiated on 26 Aug 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2861-2016
- FDA event ID
- 75051
- Recalling firm
- Abbott Medical Optics Inc. (AMO), Santa Ana, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 26 Aug 2016
- FDA classified
- 21 Sep 2016
- Reported
- 28 Sep 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Contact Lenses & Eye Devices
Timeline
| 26 Aug 2016 | Recall initiated by company | |
| 21 Sep 2016 | Classified by FDA | +26 days |
| 28 Sep 2016 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Product as listed by the FDA
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.
Where it was distributed
Worldwide Distribution - US nationwide, PR, and Internationally to Canada, Latin America, Europe, Africa, Middle East, and Asia Pacific.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
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 7732131310 7732141310 7732151310 7732161310 7732181310 7732191310 7732201310 7732211310 7732221310 7732231310 7732241310 7732251310 7732261310 7732271310 7732281310 7732291310 7732301310 7732311310 7732321310 7732331310 7732341310 7732361310 7732371310 7732391310 7732401310 7732411310 7732421310 7732431310 7732441310 7732451310 7732461310 7732471310 7732481310 7732491310 7732501310 7732511310 7732521310
Where was it sold?
Worldwide Distribution - US nationwide, PR, and Internationally to Canada, Latin America, Europe, Africa, Middle East, and Asia Pacific.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
9 other products · FDA event 75051This product is part of a recall event; the main page for the event is Tecnis OptiBlue 1-Piece Intraocular Lens (IOL) recalled.
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