AMO TECNIS CL Foldable Silicone IOLs Recalled for Incorrect Diopter Labeling
AMO Puerto Rico Manufacturing is recalling 169 units of TECNIS CL Foldable Silicone IOLs because they may be labeled with the incorrect diopter power.
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 the hazard is 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 169 units of AMO TECNIS CL Foldable Silicone IOLs with OptiEdge Design, Model Z9002, in diopter sizes 16.0 and 21.0. The recall was initiated because certain units may be labeled with the incorrect diopter power.
The affected devices are indicated for primary implantation for the visual correction of aphakia in adult patients. The recall covers units distributed nationwide in the United States as well as in Australia, Great Britain, Canada, and Japan.
Healthcare providers and patients should verify the diopter power of implanted or pending devices against the specific lot codes listed in the official recall notice. If a device is found to have incorrect labeling, it should be reported to the manufacturer or the FDA.
The recalled product
- Product
- AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002, diopter size: 16.0 and 21.0. Indicated for primary implantation for the visual correction of aphakia in adult patients.
- Manufacturer
- AMO Puerto Rico Manufacturing, Inc.
- Hazard
- Affected units
- 169
Distribution
Distributed nationwide across the United States.
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