Data / Medical devices / Lens, Multifocal Intraocular
Lens, Multifocal Intraocular (MFK): 15 FDA-registered makers in 7 countries
15 establishments in 7 countries are registered with the FDA to make Lens, Multifocal Intraocular (product code MFK, Class 3, 21 CFR 886.3600). 10 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 2 recall events (1 Class I). FDA data exported November 2, 2026.
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- Product code
- MFK
- Device class
- 3
- Regulation
- 886.3600
- Medical specialty
- Ophthalmic
- Implant
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 9 |
| Ireland | 1 |
| Netherlands | 1 |
| Barbados | 1 |
| Belgium | 1 |
| Indonesia | 1 |
| United Kingdom | 1 |
Makers of Lens, Multifocal Intraocular
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 |
|---|---|---|---|---|---|---|---|---|
| Amo Puerto Rico Manufacturing, Inc | Anasco, PR, United States | Manufacturer | 0 | 2 | 0 | 0 | api.fda.gov | |
| Johnson & Johnson Surgical Vision, Inc. | Irvine, CA, United States | Manufacturer, Specification developer | 0 | 2 | 0 | 0 | api.fda.gov | |
| Alcon Laboratories Ireland Ltd. | CORK Cork(City), Ireland | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Amo Groningen BV | Groningen, Netherlands | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Alcon Research, LLC | Huntington, WV, United States | Manufacturer, Manufacturer for export | 0 | 1 | 0 | 0 | api.fda.gov | |
| Alcon Research, LLC | Lesage, WV, United States | Manufacturer, Manufacturer for export | 0 | 1 | 0 | 0 | api.fda.gov | |
| Bausch & Lomb Incorporated | Rochester, NY, United States | Complaint file establishment, Specification developer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Bausch & Lomb Incorporated | Clearwater, FL, United States | Manufacturer | 0 | 1 | 1 | 1 | api.fda.gov | |
| Lenstec Barbados, Inc. | Christ Church, Barbados | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Lenstec, Inc. | Saint Petersburg, FL, United States | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Alcon Research, LLC | Fort Worth, TX, United States | Specification developer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Eyekon Medical, Inc. | Clearwater, FL, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Physiol.s.a | Liege, Belgium | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| PT. Ciba Vision Batam | BATAM ISLAND Riau, Indonesia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Rayner Intraocular Lenses Limited | Worthing West Sussex, United Kingdom | Complaint file establishment, 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.