Abbott Recalls SENSAR Intraocular Lenses Due to Mislabeled Units
Abbott Medical Optics is recalling 84 SENSAR Foldable Intraocular Lenses because they were not checked prior to release, which may result in the release of mislabeled units.
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 involves a labeling error (mislabeled IOLs) without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Abbott Medical Optics Inc. (AMO) is recalling 84 units of SENSAR Foldable Intraocular Lenses (IOLs) with OptiEdge Design, Model No. AR40e. The recall was initiated because the lenses were not being checked prior to release, a process failure that may result in the release of mislabeled IOLs.
The affected products are 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 lenses are intended to be placed in the capsular bag. The recall covers units distributed worldwide, including the US nationwide, Puerto Rico, Canada, Latin America, Europe, Africa, the Middle East, and Asia Pacific.
Healthcare providers and patients should check their inventory or medical records for the specific serial numbers listed in the recall notice. If a patient has received one of these lenses, they should contact their eye care provider for further instructions.
The recalled product
- Product
- SENSAR Foldable IOL with OptiEdge Design, Model No. AR40e 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…
- Manufacturer
- Abbott Medical Optics Inc. (AMO)
- Hazard
- Affected units
- 84
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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