AMO Puerto Rico Manufacturing, Inc.
AMO Puerto Rico Manufacturing, Inc. appears in FDA public data with 19 recalls, 0 510(k) clearances, 8 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1634-2026, Class II) was initiated on February 19, 2026.
Summary
- Total Recalls
- 19
- 510(k) Clearances
- 0
- Inspections
- 8
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-1634-2026 | Class II | Brand Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery System Product Name: TECNIS Eyhance | February 19, 2026 |
| Z-2273-2014 | Class II | AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implant | May 13, 2014 |
| Z-2272-2014 | Class II | AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implant | May 13, 2014 |
| Z-2287-2014 | Class II | AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implant | May 13, 2014 |
| Z-2280-2014 | Class II | AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implant | May 13, 2014 |
| Z-2283-2014 | Class II | AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implant | May 13, 2014 |
| Z-2271-2014 | Class II | AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implant | May 13, 2014 |
| Z-2278-2014 | Class II | AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implant | May 13, 2014 |
| Z-2282-2014 | Class II | AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implant | May 13, 2014 |
| Z-2277-2014 | Class II | AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implant | May 13, 2014 |
| Z-2274-2014 | Class II | AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implant | May 13, 2014 |
| Z-2281-2014 | Class II | AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implant | May 13, 2014 |
| Z-2275-2014 | Class II | AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implant | May 13, 2014 |
| Z-2279-2014 | Class II | AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implant | May 13, 2014 |
| Z-2285-2014 | Class II | AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implant | May 13, 2014 |
| Z-2276-2014 | Class II | AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implant | May 13, 2014 |
| Z-2286-2014 | Class II | AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implant | May 13, 2014 |
| Z-2284-2014 | Class II | AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implant | May 13, 2014 |
| Z-1123-2014 | Class II | AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002, diopter size: 16.0 and 21.0. | January 28, 2014 |