Data / Medical devices / Implant, Eye Sphere
Implant, Eye Sphere (HPZ): 6 FDA-registered makers in 4 countries
6 establishments in 4 countries are registered with the FDA to make Implant, Eye Sphere (product code HPZ, Class 2, 21 CFR 886.3320). 5 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 39 510(k) clearances under this code, the latest on June 24, 2022, and lists 4 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- HPZ
- Device class
- 2
- Regulation
- 886.3320
- Medical specialty
- Ophthalmic
- Implant
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 3 |
| France | 1 |
| Mauritius | 1 |
| United Kingdom | 1 |
Makers of Implant, Eye Sphere
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 |
|---|---|---|---|---|---|---|---|---|
| Fci SAS | BESANCON Doubs, France | Manufacturer | 4 | June 24, 2022 | 0 | 0 | 0 | api.fda.gov |
| Fci Sud | MAPOU LECLEZIO GOODLANDS Riviere du Rempart, Mauritius | Manufacturer, Specification developer | 4 | June 24, 2022 | 0 | 0 | 0 | api.fda.gov |
| Integrated Orbital Implants, Inc. | San Diego, CA, United States | Repackager or relabeler, Specification developer | 2 | December 28, 1998 | 0 | 2 | 0 | api.fda.gov |
| Ceramisys Ltd | Sheffield York, United Kingdom | Manufacturer | 1 | November 2, 2011 | 0 | 0 | 0 | api.fda.gov |
| Gulden Ophthalmics | Elkins Park, PA, United States | Manufacturer | 1 | October 3, 1997 | 0 | 0 | 0 | api.fda.gov |
| Armm, Inc. | Huntington Beach, CA, United States | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated June 24, 2022. 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.