Data / Medical devices / Intraocular Pressure Lowering Implant
Intraocular Pressure Lowering Implant (OGO): 7 FDA-registered makers in 2 countries
7 establishments in 2 countries are registered with the FDA to make Intraocular Pressure Lowering Implant (product code OGO, Class 3). 4 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 1 recall event (1 Class I). FDA data exported November 2, 2026.
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- Product code
- OGO
- Device class
- 3
- Medical specialty
- Unknown
- Implant
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 6 |
| Japan | 1 |
Makers of Intraocular Pressure Lowering Implant
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Alcon Research, LLC | Sinking Spring, PA, United States | Manufacturer, Manufacturer for export | 0 | 2 | 1 | 1 | api.fda.gov | |
| Glaukos Corporation | San Clemente, CA, United States | Complaint file establishment, Manufacturer | 0 | 2 | 0 | 0 | api.fda.gov | |
| Alcon Research, LLC | Lake Forest, CA, United States | Specification developer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Glaukos Corporation | Aliso Viejo, CA, United States | Specification developer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Aomi Precision Co. Ltd. | Niigata, Japan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| InnFocus, Inc. | Miami, FL, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sterigenics U.S., LLC | Corona, CA, United States | Contract sterilizer, Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 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.