Alcon Laboratories announced that it received clearance from the FDA to complete its voluntary medical device corrective action plan on its proprietary vitreoretinal system (Constellation Vision System) in the United States.
Huenenberg, Switzerland-Alcon Laboratories announced that it received clearance from the FDA to complete its voluntary medical device corrective action plan on its proprietary vitreoretinal system (Constellation Vision System) in the United States.
Alcon submitted a 510(k) for the voluntary corrective action plan to the FDA in May. The plan included specific hardware and software modifications to address identified reported events.
“We are pleased to have received clearance from the FDA and we will now proceed with our plan to upgrade [the system],” said Stuart Raetzman, vice president, global marketing and area president for the United States. “These modifications have been successful outside the United States and we are confident they will address the identified performance issues and allow our customers to use the . . . vision system without any restrictions.”
Alcon established a loaner program to provide support to customers affected by its voluntary corrective action plan. This program allowed physicians to continue providing high-quality vitreoretinal surgery to their patients while the company was waiting for the FDA clearance of the modifications. The program provided surgical systems (ACCURUS), lasers (PUREPOINT), and other needed surgical accessories.
Alcon said in a prepared statement that it will work as quickly as possible to implement the modifications to existing customer systems and these modifications will be immediately included with all new system installations. Alcon’s technical customer service team will contact customers to schedule the modifications for the vitreoretinal system.
For assistance and questions, customers may contact their Alcon surgical sales representative or technical consumer affairs at 800/561-6466, option 8.