Data / Medical devices / Folders And Injectors, Intraocular Lens (Iol)
Folders And Injectors, Intraocular Lens (Iol) (MSS): 29 FDA-registered makers in 7 countries
29 establishments in 7 countries are registered with the FDA to make Folders And Injectors, Intraocular Lens (Iol) (product code MSS, Class 1, 21 CFR 886.4300). 22 of them have a 510(k) clearance or PMA approval on file and 3 have a recall event. The FDA has issued 63 510(k) clearances under this code, the latest on June 10, 2026, and lists 5 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- MSS
- Device class
- 1
- Regulation
- 886.4300
- Medical specialty
- Ophthalmic
Makers by country
| Country | Makers |
|---|---|
| United States | 21 |
| Switzerland | 2 |
| India | 2 |
| Barbados | 1 |
| Netherlands | 1 |
| Japan | 1 |
| Taiwan | 1 |
Makers of Folders And Injectors, Intraocular Lens (Iol)
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 |
|---|---|---|---|---|---|---|---|---|
| Bausch & Lomb Incorporated | Rochester, NY, United States | Complaint file establishment, Manufacturer, Specification developer | 14 | October 10, 2024 | 0 | 0 | 0 | api.fda.gov |
| Bausch & Lomb Incorporated | Clearwater, FL, United States | Manufacturer | 7 | December 11, 2017 | 0 | 1 | 0 | api.fda.gov |
| Lenstec Barbados, Inc. | Christ Church, Barbados | Manufacturer | 5 | November 29, 2016 | 0 | 0 | 0 | api.fda.gov |
| Staar Surgical Company | Monrovia, CA, United States | Complaint file establishment, Manufacturer | 5 | September 6, 2017 | 0 | 0 | 0 | api.fda.gov |
| STAAR Surgical Company | Tustin, CA, United States | Specification developer | 5 | September 6, 2017 | 0 | 0 | 0 | api.fda.gov |
| AST Products, Inc. | Billerica, MA, United States | Specification developer | 4 | June 4, 2020 | 0 | 0 | 0 | api.fda.gov |
| Lenstec, Inc. | Saint Petersburg, FL, United States | Specification developer | 4 | November 29, 2016 | 0 | 0 | 0 | api.fda.gov |
| Amo Puerto Rico Manufacturing, Inc | Anasco, PR, United States | Manufacturer | 3 | September 13, 2019 | 0 | 0 | 0 | api.fda.gov |
| Johnson & Johnson Surgical Vision, Inc. | Irvine, CA, United States | Manufacturer, Specification developer | 3 | September 13, 2019 | 0 | 0 | 0 | api.fda.gov |
| Medicel AG | Altenrhein Sankt Gallen, Switzerland | Contract manufacturer, Manufacturer | 3 | September 16, 2025 | 0 | 0 | 0 | api.fda.gov |
| Katena Products, Inc. | Parsippany, NJ, United States | Specification developer | 2 | November 7, 2007 | 0 | 0 | 0 | api.fda.gov |
| Katena Products, Inc. | Randolph, NJ, United States | Manufacturer, Repackager or relabeler | 2 | November 7, 2007 | 0 | 0 | 0 | api.fda.gov |
| RxSight Inc. | Aliso Viejo, CA, United States | Manufacturer | 2 | August 15, 2023 | 0 | 0 | 0 | api.fda.gov |
| Amo Groningen BV | Groningen, Netherlands | Manufacturer | 1 | September 13, 2019 | 0 | 0 | 0 | api.fda.gov |
| Alcon Research, LLC | Huntington, WV, United States | Manufacturer | 1 | January 5, 2001 | 0 | 0 | 0 | api.fda.gov |
| Alcon Research, LLC | Sinking Spring, PA, United States | Manufacturer | 1 | August 23, 2021 | 0 | 0 | 0 | api.fda.gov |
| Alcon Research, LLC | Fort Worth, TX, United States | Specification developer | 1 | August 23, 2021 | 0 | 1 | 0 | api.fda.gov |
| Alcon Research, LLC | Lesage, WV, United States | Manufacturer | 1 | January 5, 2001 | 0 | 0 | 0 | api.fda.gov |
| Bausch & Lomb Incorporated | Manchester, MO, United States | Manufacturer | 1 | January 9, 2014 | 0 | 0 | 0 | api.fda.gov |
| Carl Zeiss Meditec Production, LLC. | Ontario, CA, United States | Manufacturer | 1 | April 15, 2013 | 0 | 1 | 0 | api.fda.gov |
| Hoya Surgical Research Center | Tokyo, Japan | Specification developer | 1 | March 23, 2009 | 0 | 0 | 0 | api.fda.gov |
| Icares Medicus, Inc. | Zhubei Hsinchu(County), Taiwan | Contract manufacturer, Manufacturer | 1 | June 4, 2020 | 0 | 0 | 0 | api.fda.gov |
| Aurolab | MADURAI Tamil Nadu, India | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cima Technology, Inc. | Pittsburgh, PA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jellisee Ophthalmics Inc. | McLean, VA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Omni Lens Pvt. Ltd. | Gandhinagar Gujarat, India | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ophthalmic Solution Inc. | Knoxville, TN, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sdi Surgical Device International GMBH | Bruegg Bern, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| U.S. Iol, Inc. | Lexington, KY, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov |
Updated June 10, 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.