Regener-Eyes LLC announced it has officially closed the voluntary recall of its remaining product inventory of bottles of Regener-Eyes Ophthalmic Solution—a move that follows 7 months after its first initiation for the company’s older designs.
Let’s start with the basics of Regener-Eyes.
The FDA-listed Regener-Eyes Ophthalmic Solution is formulated as a non-steroidal, non-prescription, and preservative-free (PF)-based lubricant intended to:
- Provide temporary relief of burning and irritation due to eye dryness
- Provide temporary relief of discomfort due to minor eye irritations or exposure to wind or sun
- Be used as a lubricant and protectant to prevent further irritation or to relieve eye dryness
To note: Regener-Eyes’ flagship product has an OTC Monograph Final in place that was the subject of an FDA final administrative order in which the drug was deemed to be “generally recognized as safe and effective (GRASE) for its intended use.”
Now, weren't there issues with the FDA regarding the Regener-Eyes solution?
Indeed there were—going back to December 2023 and as recently as September 2024.
The crux of those most recent concerns: That this flagship product was in violation of the Federal Food Drug & Cosmetic (FD&C) Act and contained contamination risks.
- Regarding those contamination risks: The issue was that these PF-based products were packed in multi-dose vials that did not have a mechanism for backup flow prevention.
Remind me: Why is this important?
“Backflow prevention” involves the use of a device to stop water (or other fluid) from flowing in the wrong direction.
- Without such a mechanism, this wrong-way flow can cause a solution to become contaminated.
Ah, gotcha. And how was this resolved?
In December 2024, Regener-Eyes introduced newly designed bottles with backflow prevention for two of its products following discussion with the FDA to guarantee the bottles met federal standards:
- Regener-Eyes Professional Strength
- Regener-Eyes LITE
Tell me about these new ophthalmic, multidose bottles.
Featuring the company's PF formulation, each bottle is designed “to avoid bacterial contamination over treatment duration”
Another design improvement: The inclusion of Regener-Eyes’ PureFlow Technology, a one-way valve that ensures no contaminated liquid is accidentally re-introduced into the bottle after a drop is administered.
Nice! So this recall has been in effect since December 2024, right?
That’s correct. Regener-Eyes initiated it for any remaining stock of its previous bottle designs.
In announcing the move, they previously stated: “We believe this recall is the appropriate course of action for the company” to ensure both patient and physician satisfaction and feedback.
And now?
Following a comprehensive review, identifying the potential concern, and introducing its enhanced bottle design to protect against microbial contamination, Regner-Eyes shared that it is now “in full production and distribution of its upgraded bottle.”
“This improvement further safeguards product integrity and demonstrates Regener-Eyes’ commitment to continuous improvement in both safety and manufacturing processes,” the company added.