Device Dossier
UNIPURE SF6 Ophthalmic Gas Unipexy - Sulfur hexafluoride cylinder
Device Dossier for UNIPURE SF6 Ophthalmic Gas Unipexy - Sulfur hexafluoride cylinder (Sulfur hexafluoride cylinder, Class III, sponsor Alcon…
- GMDN category: Sulfur hexafluoride cylinder
- Sponsor: Alcon Laboratories
Intended purpose
An ophthalmic gas supplied in a delivery system used as an intraocular tamponade agent for reapposition of retinal and choroidal tissues in eyes with or without vitrectomy to provide temporary surface tension across retinal breaks to physically prevent fluid flow through the retinal break into the subretinal space.
Functional description
During the healing phase surface tension of the gas plugs the retinal break preventing further accumulation of fluid under the retina while the retinal pigment epithelial pump removes subretinal fluid. UNIPURE SF6 Ophthalmic Gas bubble may minimally expand within 24-48 hours. UNIPURE SF6 Ophthalmic Gas substantially diffuses from the eye in approximately 12-14 days.