AMO TECNIS CL Intraocular Lenses Recalled for Incorrect Diopter Power Labeling
AMO Puerto Rico Manufacturing is recalling 77,055 TECNIS CL intraocular lenses because they may be labeled with the incorrect diopter power.
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 the hazard is a labeling error (incorrect diopter power) rather than a direct physical defect or contamination, which aligns with the 'Moderate' criteria for labeling errors.
Plain-English summary
AMO Puerto Rico Manufacturing, Inc. is recalling 77,055 units of AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. These are monofocal foldable intraocular lenses indicated for primary implantation for the visual correction of aphakia in adult patients.
The recall was initiated because the units may be labeled with the incorrect diopter power. The affected lenses are distributed worldwide, including in the United States, Puerto Rico, Latin America, Asia Pacific, Canada, Europe, Africa, the Middle East, and Japan.
Healthcare providers and patients should check the serial numbers of their implanted or pending lenses against the list provided in the official recall notice. If a lens is found to be affected, providers should contact AMO Puerto Rico Manufacturing for instructions on replacement or corrective action.
The recalled product
- Product
- AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 20.5-21 Product Usage: AMO TECNIS CL monofocal foldable IOL
- Manufacturer
- AMO Puerto Rico Manufacturing, Inc.
- Hazard
- Affected units
- 77,055
Distribution
Part of a larger recall action
This product is one of 17 recalled by AMO Puerto Rico Manufacturing, Inc. 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.
See all 17 products in this recall →Related recalls
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- ModerateAMO TECNIS CL Intraocular Lenses Recalled for Incorrect Diopter Power Labeling
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- ModerateAMO Tecnis CL Intraocular Lenses Recalled for Incorrect Diopter Power Labeling
FDA (Devices) · 2014-08-27
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