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Silicone Spheres (20 mm, 4.2 cc)

Oculo-Plastik Inc · Model 11-220 · UDI-DI 10697660000258

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510(k) clearances

Adverse events

Recalls

Facilities

Description

Silicone spheres are permanent implants used to replace the lost volume and to give motility to the ocular prosthesis following an enucleation, evisceration or an insertion of a secondary implant (to replace an implant that was or has to be removed) in ophthalmology. These ocular implants are sold non sterile. They must be sterilized before usage. The silicone spheres can be autoclaved (steam). The ophthalmic surgeon chooses the size and the type of implant for the surgery.

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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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.