Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2281-2014·Announced 2014-08-27

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.

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 minor labeling error (incorrect diopter power) with no reported injuries or illnesses in the source text.

Plain-English summary

AMO Puerto Rico Manufacturing, Inc. is recalling 77,055 units of the AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. The recall is due to a labeling error where the units may be marked with the incorrect diopter power.

The affected devices are monofocal foldable intraocular lenses indicated for primary implantation for the visual correction of aphakia in adult patients. The recall covers units distributed worldwide, including the United States, Puerto Rico, Canada, Latin America, Asia Pacific, Europe, Africa, the Middle East, and Japan.

Patients who have received these lenses should consult their eye care provider to verify the correct diopter power of the implanted device. The source text does not specify a consumer action for unimplanted lenses, but the labeling error affects the accuracy of the device's optical power specification.

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: 19.5-20 Product Usage: AMO TECNIS CL monofocal foldable…
Manufacturer: AMO Puerto Rico Manufacturing, Inc.
Category: Medical Device — Intraocular Lens
Hazard: mis-labeling
Affected units: 77,055

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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 →

Same manufacturer · AMO Puerto Rico Manufacturing, Inc.

See all →

High
TECNIS Eyhance intraocular lens haptic may stick to the optic
FDA (Devices) · 2026-04-01
Moderate
AMO TECNIS CL Intraocular Lenses Recalled for Incorrect Diopter Labeling
FDA (Devices) · 2014-08-27
Moderate
AMO TECNIS CL Intraocular Lenses Recalled for Incorrect Diopter Labeling
FDA (Devices) · 2014-08-27
Moderate
AMO Tecnis CL Intraocular Lenses Recalled for Incorrect Diopter Labeling
FDA (Devices) · 2014-08-27
Moderate
AMO TECNIS CL Intraocular Lenses Recalled for Incorrect Diopter Power Labeling
FDA (Devices) · 2014-08-27

Same hazard · mis labeling