Orbital sphere implant
FCI S A S FCI 20 22 · Model BIOCERAMIC ORBITAL IMPLANT Ø 21 mm · UDI-DI 03760087122985
Description
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 impart motion to the eventual ocular prosthesis (the artificial eyeball). It is typically aspherical and may have porous surfaces to facilitate colonization by fibrovascular tissue to offer the advantages of reduced risk of infection or implant extrusion. It is available in various sizes and is typically made of polymethylmethacrylate (PMMA), poly 2-hydroxyethylmethacrylate (PHEMA), or silicone.
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 the expiration date o |
| 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 cardboard box appli |
| 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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