Regener-Eyes announced the US Food and Drug Administration (FDA) has officially closed the voluntary product recall, marking full recall regulatory resolution and a return to normal operations.

The recall was initiated out of an abundance of caution and reflects Regener-Eyes' unwavering dedication to patient safety, the company said in a press release. After a comprehensive review, the company identified a potential concern and introduced an enhanced bottle design featuring advanced backflow prevention technology to help protect against microbial contamination. According to the company, this improvement further safeguards product integrity and demonstrates Regener-Eyes' commitment to continuous improvement in both safety and manufacturing processes. 

"By proactively initiating this voluntary recall, we took an already safe product and made it even safer," said a company spokesperson, in the press release. "This outcome reinforces patient and provider trust and our commitment to delivering the highest standards of safety and quality."

Regener-Eyes said it is in full production and distribution of its upgraded bottle and remains confident in its continued safety and efficacy. The company also said it remains dedicated to transparent communication with health care providers, patients, and regulators as it reaffirms the mission to deliver innovative solutions for ocular health.