CLASS II Device recall · Reported 28 Sep 2016 · FDA Enforcement Report
Tecnis 1-Piece IOL recalled by Abbott Medical Optics Inc.
Abbott Medical Optics Inc. (AMO) is recalling Tecnis 1-Piece IOL, 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-2858-2016
- 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, Model No. ZCB00 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. 2005271506 5914601206 4651021512 5807371506 4427981206 4427991206 4428001206 4428011206 4428021206 4428031206 4428041206 4428051206 4428061206 4428071206 4428081206 4428091206 4428101206 4428111206 4428121206 4428131206 4428141206 4428151206 4428161206 4428171206 4428181206 4428191206 4428201206 4428211206 4428221206 4428231206 4428241206 4428251206 4428261206 4428271206 4428281206 4428291206 4428311206 4428321206 4428331206 4428341206 4428351206 4428361206 4428371206 4428381206 5152461501 5152471501 5152481501 5152491501 5152501501 5152531501 5152541501 5152551501 5152561501 5152571501 5152581501 5152591501 5152601501 5152611501 5152621501 5152631501 5152641501 5152651501 5152661501 5152671501 4428301206
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.
More recalls from Abbott Medical Optics Inc. (AMO)
All 19Other Contact Lenses & Eye Devices recalls
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|---|---|---|---|---|---|
| Device | CLASS II | Pearle Vision 1 day (somofilcon A) Contact Lens recalled by CooperVision | CooperVision | Other | Nationwide |
| Device | CLASS II | Tecnis Eyhance Iol with Tecnis Simplicity" Delivery System recalled | AMO Puerto Rico Manufacturing | Device Malfunction | Nationwide |
| Device | CLASS II | Alcon PRECISION1 One-Day Contact Lenses, -2.25D recalled | Alcon Research | Sterility | 19 states |
| Device | CLASS II | Sofmed Breathables, (stenfilcon A) contact lens recalled by CooperVision | CooperVision | Sterility | Nationwide |
| Device | CLASS II | Voyant 1-Day Premium Toric, (stenfilcon A) contact lens recalled | CooperVision | Sterility | Nationwide |