Data / Medical devices / Products, Contact Lens Care, Rigid Gas Permeable
Products, Contact Lens Care, Rigid Gas Permeable (MRC): 17 FDA-registered makers in 7 countries
17 establishments in 7 countries are registered with the FDA to make Products, Contact Lens Care, Rigid Gas Permeable (product code MRC, Class 2, 21 CFR 886.5918). 8 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 33 510(k) clearances under this code, the latest on October 9, 2025, and lists 4 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- MRC
- Device class
- 2
- Regulation
- 886.5918
- Medical specialty
- Ophthalmic
Makers by country
| Country | Makers |
|---|---|
| United States | 8 |
| Japan | 3 |
| France | 2 |
| China | 1 |
| Ireland | 1 |
| Canada | 1 |
| Taiwan | 1 |
Makers of Products, Contact Lens Care, Rigid Gas Permeable
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, Specification developer | 7 | September 23, 2020 | 0 | 1 | 0 | api.fda.gov |
| Bausch & Lomb Incorporated | Greenville, SC, United States | Manufacturer | 5 | August 10, 2018 | 0 | 0 | 0 | api.fda.gov |
| Menicon Co., Ltd., R&D Center | Kasugai Aichi, Japan | Specification developer | 2 | November 16, 2017 | 0 | 0 | 0 | api.fda.gov |
| Amo (hangzhou) Co., Ltd. | HANGZHOU Zhejiang, China | Manufacturer | 1 | October 19, 2004 | 0 | 0 | 0 | api.fda.gov |
| Dry Eye Innovations, LLC | Franklin, TN, United States | Specification developer | 1 | July 31, 2020 | 0 | 0 | 0 | api.fda.gov |
| Menicon Pharma SAS | ILLKIRCH-GRAFFENSTADEN Bas-Rhin, France | Manufacturer | 1 | July 3, 2013 | 0 | 0 | 0 | api.fda.gov |
| Menicon Nect Co., Ltd., Gujo Plant | Gujo Gifu, Japan | Manufacturer | 1 | November 16, 2017 | 0 | 0 | 0 | api.fda.gov |
| Ophtecs Manufacturing Ltd. | Toyooka Hyogo, Japan | Manufacturer | 1 | October 9, 2025 | 0 | 0 | 0 | api.fda.gov |
| Allergan Pharmaceuticals Ireland | WESTPORT Mayo, Ireland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Allergan Sales, LLC | Irvine, CA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Altaire Pharmaceuticals, Inc. | Aquebogue, NY, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Alcon Research, LLC | Fort Worth, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ClensTech Inc.dba ASEPT PAK INC. | Malone, NY, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Laboratoire Unither | Coutances Normandie, France | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Niagara Pharmaceuticals, Inc. | Dundas Ontario, Canada | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Taiwan Biotech Co., Ltd. | Taoyuan, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| The Lifestyle Co., Inc. | Freehold, NJ, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated October 9, 2025. 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.