Data / Medical devices / Implant, Eye Valve
Implant, Eye Valve (KYF): 12 FDA-registered makers in 5 countries
12 establishments in 5 countries are registered with the FDA to make Implant, Eye Valve (product code KYF, Class 2, 21 CFR 886.3920). 9 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 25 510(k) clearances under this code, the latest on May 12, 2023, and lists 3 recall events (0 Class I). FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Product code
- KYF
- Device class
- 2
- Regulation
- 886.3920
- Medical specialty
- Ophthalmic
- Implant
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 8 |
| New Zealand | 1 |
| Netherlands | 1 |
| Israel | 1 |
| Japan | 1 |
Makers of Implant, Eye Valve
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 |
|---|---|---|---|---|---|---|---|---|
| Molteno Ophthalmic Ltd. | DUNEDIN Otago, New Zealand | Manufacturer | 4 | December 17, 2015 | 0 | 0 | 0 | api.fda.gov |
| New World Medical, Inc. | Rancho Cucamonga, CA, United States | Complaint file establishment, Manufacturer | 3 | May 12, 2023 | 0 | 0 | 0 | api.fda.gov |
| Amo Groningen BV | Groningen, Netherlands | Manufacturer | 2 | February 18, 1997 | 0 | 0 | 0 | api.fda.gov |
| Johnson & Johnson Surgical Vision, Inc. | Irvine, CA, United States | Manufacturer, Specification developer | 2 | February 18, 1997 | 0 | 0 | 0 | api.fda.gov |
| Allergan Sales, LLC | Irvine, CA, United States | Complaint file establishment, Specification developer | 1 | November 21, 2016 | 0 | 1 | 0 | api.fda.gov |
| Alcon Research, LLC | Sinking Spring, PA, United States | Manufacturer | 1 | March 26, 2002 | 0 | 0 | 0 | api.fda.gov |
| Glaukos Corporation | Aliso Viejo, CA, United States | Specification developer | 1 | August 2, 2022 | 0 | 0 | 0 | api.fda.gov |
| Glaukos Corporation | San Clemente, CA, United States | Complaint file establishment, Manufacturer | 1 | August 2, 2022 | 0 | 0 | 0 | api.fda.gov |
| Optonol, Ltd | NEVE ILAN Central, Israel | Manufacturer | 1 | March 26, 2002 | 0 | 0 | 0 | api.fda.gov |
| Aomi Precision Co. Ltd. | Niigata, Japan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Trelleborg Sealing Solutions Us, Inc. | Paso Robles, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Trelleborg Sealing Solutions US, Inc. | Tustin, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated May 12, 2023. 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.