Company
AMO Puerto Rico Manufacturing, Inc.
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
19recalls (1 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| HQL | Intraocular Lens | 19 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 24, 2026 | AMO Puerto Rico Manufacturing, Inc. Brand Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery System
Product Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery System
Model/Catalog Number: DIB00
Software Version: N/A
Produc Open, Classified |
HQL | None listed |
| Aug 26, 2014 | AMO Puerto Rico Manufacturing, Inc. 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 followin Terminated |
HQL | None listed |
| Aug 26, 2014 | AMO Puerto Rico Manufacturing, Inc. 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 followin Terminated |
HQL | None listed |
| Aug 26, 2014 | AMO Puerto Rico Manufacturing, Inc. 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 followin Terminated |
HQL | None listed |
| Aug 26, 2014 | AMO Puerto Rico Manufacturing, Inc. 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 followin Terminated |
HQL | None listed |
| Aug 26, 2014 | AMO Puerto Rico Manufacturing, Inc. 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 followin Terminated |
HQL | None listed |
| Aug 26, 2014 | AMO Puerto Rico Manufacturing, Inc. 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 followin Terminated |
HQL | None listed |
| Aug 26, 2014 | AMO Puerto Rico Manufacturing, Inc. 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 followin Terminated |
HQL | None listed |
| Aug 26, 2014 | AMO Puerto Rico Manufacturing, Inc. 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 followin Terminated |
HQL | None listed |
| Aug 26, 2014 | AMO Puerto Rico Manufacturing, Inc. 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 followin Terminated |
HQL | None listed |
| Aug 26, 2014 | AMO Puerto Rico Manufacturing, Inc. 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 followin Terminated |
HQL | None listed |
| Aug 26, 2014 | AMO Puerto Rico Manufacturing, Inc. 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 followin Terminated |
HQL | None listed |
| Aug 26, 2014 | AMO Puerto Rico Manufacturing, Inc. 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 followin Terminated |
HQL | None listed |
| Aug 26, 2014 | AMO Puerto Rico Manufacturing, Inc. 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 followin Terminated |
HQL | None listed |
| Aug 26, 2014 | AMO Puerto Rico Manufacturing, Inc. 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 followin Terminated |
HQL | None listed |
| Aug 26, 2014 | AMO Puerto Rico Manufacturing, Inc. 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 followin Terminated |
HQL | None listed |
| Aug 26, 2014 | AMO Puerto Rico Manufacturing, Inc. 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 followin Terminated |
HQL | None listed |
| Aug 26, 2014 | AMO Puerto Rico Manufacturing, Inc. 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 followin Terminated |
HQL | None listed |
| Mar 3, 2014 | AMO Puerto Rico Manufacturing, Inc. 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. Terminated |
HQL | None listed |