Abbott Recalls SENSAR Intraocular Lenses Due to Mislabeled Units
Abbott Medical Optics is recalling SENSAR 1-Piece Intraocular Lenses because they were not checked prior to release, which may result in the release of mislabeled units.
What this means for you
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 SENSAR 1-Piece Intraocular Lenses, Model No. AAB00, because the devices were not being checked prior to release. This failure in the quality control process may result in the release of mislabeled intraocular lenses.
The affected 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. The recall involves a specific unit with Serial No. 5050941602.
The product was distributed worldwide, including the US nationwide, Puerto Rico, and internationally to Canada, Latin America, Europe, Africa, the Middle East, and Asia Pacific. Healthcare providers and patients should verify the serial number of their devices against the recall notice to determine if they are affected.
The recalled product
- Product
- SENSAR 1-Piece IOL, Model No. AAB00 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.
- Manufacturer
- Abbott Medical Optics Inc. (AMO)
- Hazard
- Affected units
- 1
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Serial No. 5050941602
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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