Home › Device types › HPZ
Implant, Eye Sphere
FDA product code HPZ · Class 2 · Ophthalmic
156
Registered devices
33
Adverse events
4
Recalls
39
510(k) clearances
Devices with this code
Orbital sphere implant — FCI S A S FCI 20 22Silicone Spheres (18 mm, 3.1 cc) — Oculo-Plastik IncEZYPOR® Ø 18 mm — FCI S A S FCI 20 22Silicone Spheres (22 mm, 5.6 cc) — Oculo-Plastik IncAmbler Surgical — AMBLER SURGICAL CORP.Orbtex Orbital Implant — CERAMISYS LTDAcrylic Spheres 12 mm, 1.1 cc — Oculo-Plastik IncSilicone Spheres (19 mm, 3.6 cc) — Oculo-Plastik IncSilicone Spheres (15 mm, 1.8 cc) — Oculo-Plastik Inc22mm Sterile Orbital Implant (PMMA) — Gulden Ophthalmics Inc.10mm Sterile Orbital Implant (PMMA) — Gulden Ophthalmics Inc.EYE SPHERE PLASTIC 18MM DIAMETER — KATENA PRODUCTS, INC.Orbital sphere implant — FCI S A S FCI 20 2216mm Eye Sphere (non-sterile) — Gulden Ophthalmics Inc.Ambler Surgical — AMBLER SURGICAL CORP.Orbital sphere implant — FCI S A S FCI 20 22Bio-Eye® — INTEGRATED ORBITAL IMPLANTS INCHydroxyapatite Orbital Implant — CERAMISYS LTDOrbital sphere implant — FCI S A S FCI 20 22Orbital sphere implant — FCI S A S FCI 20 2222mm Eye Sphere (non-sterile) — Gulden Ophthalmics Inc.Silicone Spheres (21 mm, 4.8 cc) In Bulk — Oculo-Plastik IncOrbital sphere implant — FCI S A S FCI 20 22Silicone Eye Sphere - 14mm — Gulden Ophthalmics Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2012-03-20 | Howmedica Osteonics Corp dba Stryker Craniomaxillofacial | The MEDPOR PLUS SST EZ 22mm sphere implants are not within specification of 22mm +/- 8, therefore implant is not easily released from the syringe. |
| 2010-06-07 | Integrated Orbital Implants Inc | Integrated Orbital Implants, Inc. has initiated a recall of it's Sterile Bio-Eye Hydroxyapatite Orbital Implant and Conformer due to a labeling issue in which t |
| 2006-02-27 | Integrated Orbital Implants Inc | The end label on the outer box was mislabeled on 9 of a 10 unit lot. The end label says ''22 mm'' and the implants are actually ''20 mm''. The main label on the |
| 2005-03-07 | Porex Surgical, Inc. | The product, which is a 20mm MEDPOR Sphere, was mislabeled in that the package contained 18mm MEDPOR Spheres |
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