AMO TECNIS CL Intraocular Lenses Recalled for Incorrect Diopter Power Labeling
AMO Puerto Rico Manufacturing is recalling 77,055 TECNIS CL intraocular lenses because units 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: This is an FDA Class II recall involving a labeling error (incorrect diopter power) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
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 units may be labeled with the incorrect diopter power. The affected products were 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 their inventory or surgical records for the specific lot codes listed in the official recall notice. If a patient has received an affected lens, they should contact their ophthalmologist to discuss the potential impact of the incorrect power labeling on their vision correction.
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: 14.5, 15.0 Product Usage: AMO TECNIS CL monofocal foldable
- 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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