An implantable ocular device designed to permanently fill the orbital cavity following enucleation, evisceration, or after the removal of another ocular implant (used as a secondary implant), to replace the volume and possibly, given the surgical method, to im
| Company | Devices | Share |
|---|---|---|
| Fci S A S Fci 20 22 | 31 | 36% |
| Gulden Ophthalmics Inc. | 21 | 24% |
| Ambler Surgical Corp. | 15 | 17% |
| Stryker Leibinger Gmbh & Co. Kg | 10 | 12% |
| Katena Products, Inc. | 7 | 8% |
| Integrated Orbital Implants Inc | 2 | 2% |
Company = labeler of record on GUDID. 6 companies in total; top 12 shown. Click headers to sort.
Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.
| Code | Name | Devices |
|---|---|---|
| HPZ | Implant, Eye Sphere | 123 |
| HPZ | IMPLANT, EYE SPHERE | 15 |
| FWP | PROSTHESIS, CHIN, INTERNAL | 10 |
| MTZ | Wrap, Implant, Orbital | 2 |
| HQN | Conformer, Ophthalmic | 2 |
Use these as the dimensions to specify in a tender line.
86 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Orbital sphere implant", from 6 companies. The largest labeler is Fci S A S Fci 20 22 with 36% of records.
HPZ (Implant, Eye Sphere), HPZ (IMPLANT, EYE SPHERE), FWP (PROSTHESIS, CHIN, INTERNAL), MTZ (Wrap, Implant, Orbital)
No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.
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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.