Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2276-2014·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 units 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: 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.
Category: Medical Device — Intraocular Lenses
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