UNIPURE C3F8 Ophthalmic Gas, UNIFEYE Gas Delivery System, UNIPEXY Gas Delivery System – P220030
This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: UNIPURE C3F8 Ophthalmic Gas in the UNIFEYE Gas Delivery System UNIPURE C3F8 Ophthalmic Gas in the UNIPEXY Gas Delivery System
PMA Applicant: Alcon Research, LLC
Address: 20511 Lake Forest Drive, Lake Forest, CA 92630, USA
Approval Date: July 2, 2024
Approval Letter: Approval order
What is it?
UNIPURE C3F8 Ophthalmic Gas is a gas that can be injected into the eye for the treatment of uncomplicated retinal detachment. The UNIPURE C3F8 Ophthalmic Gas is delivered through one of two delivery systems: the UNIFEYE Gas Delivery System or the UNIPEXY Gas Delivery System.
The UNIFEYE Gas Delivery System injects filtered UNIPURE C3F8 Ophthalmic Gas mixed with filtered air into the eye. The UNIPEXY Gas Delivery System injects undiluted, filtered UNIPURE C3F8 Ophthalmic Gas into the eye.
UNIPURE C3F8 Ophthalmic Gas is injected into the vitreous cavity, the gel like space that fills the inside of the eyeball (vitreous cavity). A gas bubble forms and helps the retina re-attach by pushing the detached retina back in place and blocking additional fluid from passing from the vitreous cavity through the retinal tear and behind the detached retina. While the tear or hole that formed in the retina (retinal break) heals, the gas holds the retina in place and keeps fluid from entering the space between the detached retina and its supporting structures. The gas bubble helps keep the retina stable until the gas dissolves in approximately 6 to 8 weeks.
UNIPURE C3F8 Ophthalmic Gas in the UNIFEYE Gas Delivery System and UNIPURE C3F8 Ophthalmic Gas in the UNIPEXY Gas Delivery System are intended to treat uncomplicated retinal detachments.
UNIPURE C3F8 Ophthalmic Gas, delivered through the UNIFEYE or UNIPEXY Gas Delivery Systems, is intended to help the retina re-attach. It is reported to have side effects that are tolerable. A clinical literature review of similar C3F8 gas found that based on the reports of 1,131 eyes, the overall primary retinal reattachment rate reported 3 months after injection was 81.9%. Data from reports of 153 treated eyes showed that 13% had eye pressure higher than 25 mmHg (elevated intraocular pressure) one week after injection.
UNIPURE C3F8 Ophthalmic Gas should not be used if the patient:
- Has certain serious eye conditions such as diabetic eye disease, severely high eye pressure, or inflammation in the eye.
- Requires high-pressure oxygen therapy (hyperbaric oxygen) or nitrous oxide before the gas dissolves.
- Cannot avoid high altitude or airplane travel before the gas dissolves.
Safety and effectiveness have not been established for pregnant women.