TECNIS Multifocal Foldable Acrylic Intraocular Lens — Class II medical device recall Z-2863-2016
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-2863-2016 |
|---|---|
| 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 | 41 units |
| Reason classes | labeling |
| Serial numbers | 8213991504, 8214001504, 8214011504, 8214021504, 8214031504, 8214041504, 8214051504, 8214061504, 8214071504, 8214101504, 8416821507, 8416831507, 8416841507, 8416851507, 8416911507, 8416921507, 8416951507, 8416961507, 8416971507, 8416991507, 8417001507, 8417011507, 8417021507, 8417041507, 8417071507 and 16 more |
| Model numbers | ZMA00 |
Product
TECNIS Multifocal Foldable Acrylic Intraocular Lens, Model No. ZMA00 The product is indicated for 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 who desire near, intermediate, and distance vision with 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.