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: The recall is classified as FDA Class II and involves a labeling error regarding diopter power. The source text does not report any illnesses or injuries, fitting the criteria for a moderate severity labeling issue.
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 medical devices are 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 lenses are distributed worldwide, including in the United States, Puerto Rico, Latin America, Asia Pacific, Canada, Europe, Africa, the Middle East, and Japan.
Patients who have received these lenses should contact their eye care provider to verify the correct diopter power of the implanted device. The source text does not report any illnesses or injuries associated with this labeling error.
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: 15.5, 16.0 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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