Data / Medical devices / Conformer, Ophthalmic
Conformer, Ophthalmic (HQN): 22 FDA-registered makers in 6 countries
22 establishments in 6 countries are registered with the FDA to make Conformer, Ophthalmic (product code HQN, Class 2, 21 CFR 886.3130). 1 of them has a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 7 510(k) clearances under this code, the latest on January 20, 1998, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- HQN
- Device class
- 2
- Regulation
- 886.3130
- Medical specialty
- Ophthalmic
Makers by country
| Country | Makers |
|---|---|
| United States | 15 |
| India | 3 |
| Germany | 1 |
| France | 1 |
| Mauritius | 1 |
| Canada | 1 |
Makers of Conformer, Ophthalmic
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 |
|---|---|---|---|---|---|---|---|---|
| Stryker Leibinger GMBH & Co. KG | FREIBURG Baden-Wurttemberg, Germany | Complaint file establishment, Specification developer | 1 | January 20, 1998 | 0 | 0 | 0 | api.fda.gov |
| Akriti Ophthalmic Private Limited | Hyderabad Telangana, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Armm, Inc. | Huntington Beach, CA, United States | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bausch & Lomb Incorporated | Manchester, MO, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dallas Eye Prosthetics | Dallas, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fci SAS | BESANCON Doubs, France | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fci Sud | MAPOU LECLEZIO GOODLANDS Riviere du Rempart, Mauritius | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gulden Ophthalmics | Elkins Park, PA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Integrated Orbital Implants, Inc. | San Diego, CA, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jardon Eye Prosthetics, Inc. | Southfield, MI, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Katena Products, Inc. | Parsippany, NJ, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lights' Prosthetic Eyes, Inc. | Peoria, IL, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| M/S Tarun Enterprises | Prayagraj, Uttar Pradesh, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Midwest Eye Laboratories Sioux Falls LLC | Sioux Falls, SD, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Midwest Eye Laboratories Woodbury LLC | Saint Paul, MN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Midwest Eye Laboratories, Inc. | Rochester, MN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Midwest Eye Laboratories, Inc. | Eau Claire, WI, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Millstone Medical Outsourcing LLC. | Fall River, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Oculo Plastik, Inc. | MONTREAL Quebec, Canada | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Retivue LLC | Charlottesville, VA, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Soper Brothers & Associates | Houston, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Speedway | India Delhi, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated January 20, 1998. 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.