Abbott Recalls TECNIS Multifocal Intraocular Lenses Due to Mislabeled Units
Abbott Medical Optics is recalling 77 TECNIS Multifocal Intraocular Lenses because they were not checked prior to release, potentially resulting in mislabeled products.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard is a labeling error (mislabeled IOLs) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Abbott Medical Optics Inc. (AMO) is recalling 77 units of the TECNIS Multifocal 1-Piece Intraocular Lens, Model No. ZKB00 and ZLB00. The recall was initiated because the lenses were not being checked prior to release, which may result in the release of mislabeled intraocular lenses.
The affected products are 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. The lenses are intended to be placed in the capsular bag to provide near, intermediate, and distance vision.
The recall covers units distributed worldwide, including the US nationwide, Puerto Rico, Canada, Latin America, Europe, Africa, the Middle East, and Asia Pacific. Specific serial numbers for the affected ZKB00 and ZLB00 models are listed in the official recall documentation. Healthcare providers and patients should verify their lens serial numbers against the provided list and contact Abbott Medical Optics for further instructions.
The recalled product
- Product
- TECNIS Multifocal 1-Piece Intraocular Lens, Model No. ZKB00, ZLB00; 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…
- Manufacturer
- Abbott Medical Optics Inc. (AMO)
- Hazard
- Affected units
- 77
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 10 recalled by Abbott Medical Optics Inc. (AMO) under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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