TECNIS Symfony Extended Range of Vision IOL — Class II medical device recall Z-2857-2016
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-2857-2016 |
|---|---|
| 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 | 10 units |
| Reason classes | labeling |
| Serial numbers | 8231911605, 8231921605, 8231931605, 8231961605, 8496921508, 8496931508, 8496941508, 8496951508, 8618391605, 8618441605 |
| Model numbers | ZXR00 |
Product
TECNIS Symfony Extended Range of Vision IOL, Model No. ZXR00 The product is indicated primary implantation for the visual correction of aphakia in adult patients with and without presbyopia in whom a cataractous lens has been removed by extracapsular cataract extraction, and aphakia following refractive lensectomy in presbyopic adults, who desire useful vision over a continuous range of distances including far, intermediate and near, and increased spectacle independence. 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.