UNIPURE SF6 Ophthalmic Gas UNIFEYE Gas Delivery System and UNIPURE SF6 Ophthalmic Gas UNIPEXY Gas Delivery System - P230012
UNIPURE SF6 Ophthalmic Gas in the UNIFEYE Gas Delivery System
UNIPURE SF6 Ophthalmic Gas in the UNIPEXY Gas Delivery System
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 SF6 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE SF6 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: August 26, 2024
Approval Letter: Approval Order
What is it?
The UNIPURE SF6 Ophthalmic Gas is a gas that can be injected into the eye for the treatment of uncomplicated retinal detachments. The UNIPURE SF6 Ophthalmic Gas is delivered through one of two delivery systems, the UNIFEYE Gas Delivery System and the UNIPEXY Gas Delivery System.
The UNIFEYE Gas Delivery System injects filtered UNIPURE SF6 Ophthalmic Gas mixed with filtered air into the eye. The UNIPEXY Gas Delivery System injects filtered UNIPURE SF6 Ophthalmic Gas.
UNIPURE SF6 Ophthalmic Gas is injected into the vitreous cavity, the gel-like space that fills the inside of the eyeball. A gas bubble forms and helps the retina re-attach by pushing the detached retina back in place and blocking additional fluid from passing into the vitreous cavity and behind the detached retina through the retinal tear. While the tear or hole that formed in the retina (retinal break) heals, the gas 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 12 to 14 days.
UNIPURE SF6 Ophthalmic Gas in the UNIFEYE Gas Delivery System and UNIPURE SF6 Ophthalmic Gas in the UNIPEXY Gas Delivery System are intended to treat uncomplicated retinal detachments.
UNIPURE SF6 Ophthalmic Gas delivered using the UNIFEYE Gas Delivery System or the UNIPEXY Gas Delivery System is intended to help the retina re-attach. It is reported to have side effects that are tolerable. A clinical literature review of similar SF6 gas found that based on the reports of 1,723 eyes, the overall primary retinal reattachment rate reported 3 months after injection was 87.4%. Data from reports of 106 treated eyes showed that 10.4% had eye pressure higher than 25 mmHg (elevated intraocular pressure) one week after injection.
Treatment with UNIPURE SF6 Ophthalmic Gas should not be used if the patient:
- Has 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 ophthalmic gas bubble dissolves.
- Cannot avoid high altitude or airplane travel before the gas dissolves.
Safety and effectiveness have not been established in pregnant women.
- Summary of Safety and Effectiveness Data (SSED)
- Labeling - Physician's Directions for Use
- Patient Labeling - Patient Information Brochure
- PMA Database entry