Data / Medical devices / Lens, Guide, Intraocular / United States
FDA-registered makers of Lens, Guide, Intraocular in the United States: 17 establishments
17 establishments in the United States are registered with the FDA to make Lens, Guide, Intraocular (product code KYB). 9 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 2, 2026.
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- Device
- Lens, Guide, Intraocular
- Product code
- KYB
- Country
- United States
Makers of Lens, Guide, Intraocular in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Staar Surgical Company | Monrovia, CA, United States | Complaint file establishment, Manufacturer | 3 | October 30, 2015 | 0 | 4 | 0 | api.fda.gov |
| STAAR Surgical Company | Tustin, CA, United States | Specification developer | 3 | October 30, 2015 | 0 | 0 | 0 | api.fda.gov |
| Bausch & Lomb Incorporated | Rochester, NY, United States | Complaint file establishment, Specification developer | 2 | November 1, 2007 | 0 | 0 | 0 | api.fda.gov |
| Johnson & Johnson Surgical Vision, Inc. | Irvine, CA, United States | Manufacturer, Specification developer | 2 | October 23, 2008 | 0 | 0 | 0 | api.fda.gov |
| Amo Puerto Rico Manufacturing, Inc | Anasco, PR, United States | Manufacturer | 1 | June 17, 1996 | 0 | 0 | 0 | api.fda.gov |
| Alcon Research, LLC | Huntington, WV, United States | Manufacturer | 1 | March 27, 2007 | 0 | 0 | 0 | api.fda.gov |
| Alcon Research, LLC | Sinking Spring, PA, United States | Manufacturer | 1 | March 27, 2007 | 0 | 0 | 0 | api.fda.gov |
| Alcon Research, LLC | Lesage, WV, United States | Manufacturer | 1 | March 27, 2007 | 0 | 0 | 0 | api.fda.gov |
| Bausch & Lomb Incorporated | Clearwater, FL, United States | Manufacturer | 1 | March 7, 2007 | 0 | 0 | 0 | api.fda.gov |
| Autocam Medical | Kentwood, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Alcon Research, LLC | Lake Forest, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Alcon Research, LLC | Irvine, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Alcon Research, LLC | Houston, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beaver-Visitec International, Inc. | Waltham, MA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Carwild Corp. | New London, CT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hurricane Medical | Bradenton, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| RMS Co. | Minneapolis, MN, United States | Contract manufacturer | 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.