Data / Medical devices / United States / Amo Puerto Rico Manufacturing, Inc
Amo Puerto Rico Manufacturing, Inc: FDA-registered device maker in Anasco, PR, United States, 4 510(k) clearances and 5 PMA approvals
Amo Puerto Rico Manufacturing, Inc is registered with the FDA (registration 2648035) in Anasco, PR, United States. It lists 6 device types. The FDA files 4 510(k) clearances and 5 PMA approvals under its listings, the newest dated September 13, 2019. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2648035
- Address
- Road 402 N., Industrial Park, Anasco, PR, United States, 00610
- Owner or operator
- Johnson & Johnson Surgical Vision, Inc. (10053607)
- Roles
- Manufacturer
- First device listed
- December 22, 2016
- Registered through
- 2026
- Brand names listed
- FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL), LENS, GUIDE, INTRAOCULAR, LENS, MULTIFOCAL INTRAOCULAR, intraocular lens
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Extended Depth Of Focus Intraocular Lens | POE | 3 | Manufacturer | accessdata.fda.gov |
| Folders And Injectors, Intraocular Lens (Iol) | MSS | 1 | Manufacturer | accessdata.fda.gov |
| Intraocular Lens | HQL | 3 | Manufacturer | accessdata.fda.gov |
| Lens, Guide, Intraocular | KYB | 1 | Manufacturer | accessdata.fda.gov |
| Lens, Intraocular, Toric Optics | MJP | 3 | Manufacturer | accessdata.fda.gov |
| Lens, Multifocal Intraocular | MFK | 3 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 13, 2019 | K191949 | UNFOLDER Vitan Inserter | MSS | Substantially Equivalent | Johnson & Johnson Surgical Vision, Inc. | accessdata.fda.gov |
| May 6, 2015 | K143434 | One Series ULTRA Cartridge, The UNFOLDER Platinum 1 Series | MSS | Substantially Equivalent | Abbott Medical Optics, Inc. | accessdata.fda.gov |
| October 2, 2008 | K081545 | ONE SERIES ULTRA CARTRIDGE, MODEL 1VIPR30 | MSS | Substantially Equivalent | Advanced Medical Optics, Inc. | accessdata.fda.gov |
| June 17, 1996 | K961242 | AMO PHACOFLEX II INTERSECTION SYSTEM | KYB | Substantially Equivalent | Allergan, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| January 16, 2009 | P080010 | TECNIS MULTIFOCAL FOLDABLE POSTERIOR CHAMBER INTRAOCULAR LENS (IOL) | MFK | 29 | October 19, 2026 | accessdata.fda.gov |
| April 5, 2001 | P990080 | CEEON EDGE FOLDABLE ULTRAVIOLET LIGHT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS, MODEL 911A | HQL | 61 | October 19, 2026 | accessdata.fda.gov |
| February 3, 2000 | P980040 | SENSAR SOFT ACRYLIC UV-LIGHT ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS | HQL | 174 | October 19, 2026 | accessdata.fda.gov |
| September 5, 1997 | P960028 | AMO ARRAY MULTIFOCAL UV-ABSORBING SILCONE POSTERIOR CHAMBER INTRAOCULAR LENS | MFK | 36 | October 27, 2017 | accessdata.fda.gov |
| October 31, 1989 | P880081 | UV ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR LENSES | HQL | 39 | September 27, 2024 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| February 19, 2026 | 98402 | Class II | Ongoing | 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 Product Description: The T | Due to identifying a limited quantity of intraocular lenses that may have a haptic that sticks to the optic which prevents the lens from unfolding as consistently as expected. | accessdata.fda.gov |
| May 13, 2014 | 68346 | Class II | Terminated | 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: 5.0 | Units may be labeled with the incorrect diopter power. | accessdata.fda.gov |
| January 28, 2014 | 67385 | Class II | Terminated | 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. | Certain Silicone TECNIS IOLs may be labeled with the incorrect diopter power. | accessdata.fda.gov |
Compare with other makers
- All makers of Lens, Guide, Intraocular
- All makers of Folders And Injectors, Intraocular Lens (Iol)
- All makers of Lens, Multifocal Intraocular
- All makers of Intraocular Lens
- All makers of Extended Depth Of Focus Intraocular Lens
- All makers of Lens, Intraocular, Toric Optics
Updated October 19, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.