TECNIS OptiBlue 1-Piece IOL with the TECNIS iTec Preloaded Delivery… — Class II medical device recall Z-2862-2016
Terminated recall by Abbott Medical Optics Inc. (AMO), reported 2016-09-28, distributed nationwide. Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked prior to rele
| Recall number | Z-2862-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Medical Optics Inc. (AMO), Santa Ana, CA, United States |
| Recall initiated | 2016-08-26 |
| Classified | 2016-09-21 |
| Reported by FDA | 2016-09-28 |
| Terminated | 2016-12-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 70 units |
| Reason classes | labeling |
| Serial numbers | 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 and 45 more |
| Model numbers | PCB00V |
Product
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
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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.