TECNIS 1-Piece IOL with the TECNIS iTec Preloaded Delivery System — Class II medical device recall Z-2861-2016
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-2861-2016 |
|---|---|
| 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 | 217 units |
| Reason classes | labeling |
| Serial numbers | 2397761605, 2397981605, 2648751412, 2648761412, 2648771412, 2648781412, 2648791412, 2648801412, 2648811412, 2648821412, 2648831412, 2648841412, 2648851412, 2648861412, 2648871412, 2648881412, 2648891412, 2648901412, 2648911412, 2648921412, 2648931412, 2648941412, 2648951412, 2648961412, 2648971412 and 192 more |
| Model numbers | PCB00 |
Product
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.
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
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2861-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
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.