CLASS II Device recall · Reported 28 Sep 2016 · FDA Enforcement Report
Tecnis OptiBlue 1-Piece Iol recalled by Abbott Medical Optics Inc.
Abbott Medical Optics Inc. (AMO) is recalling Tecnis OptiBlue 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-2862-2016
- 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 OptiBlue 1-Piece IOL with the TECNIS iTec Preloaded Delivery System, Model No. PCB00V 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. 5860621403 5860631403 5860641403 5860651403 5860661403 5860671403 5860681403 5860691403 5860701403 5860711403 5860721403 5860731403 5860741403 5860751403 5860771403 5860781403 5860791403 5860801403 5860811403 5860821403 5860831403 5860851403 5860871403 5860881403 5860891403 5860901403 5860911403 5860921403 5860931403 5860941403 5860951403 5860961403 5860971403 5860981403 5860991403 5861001403 5861011403 5861021403 5861031403 5861041403 5861051403 5861061403 5861081403 5861091403 5861101403 5861111403 5861391403 5861401403 5861411403 5861421403 5861431403 5861441403 5861451403 5861461403 5861471403 5861481403 5861491403 5861501403 5861511403 5861521403 5861531403 5861541403 5861551403 5861561403 5861581403 5861591403 5861601403 5861611403 5861621403 5861631403
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)
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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 |