FDA
Warning letter 725861, BlephEx LLC
On June 3, 2026, FDA’s Center for Devices and Radiological Health issued a warning letter to BlephEx, LLC. The addressee on the letter is James M. Rynerson, M.D., listed as owner and president, at the firm’s Brentwood, Tennessee address. The letter follows an inspection of that facility from October 30 through November 19, 2025.
A warning letter is the agency’s written notice that it believes a firm has violated the Federal Food, Drug, and Cosmetic Act. It is not a recall order, a criminal charge, or a finding by a court. FDA published the letter in its public warning-letter database. These notes stay inside that document.
The three products
FDA names three devices:
- BlephEx Powered Eyelid Cleaning Sponge
- OptiVize Ophthalmic Battery-Powered Electrolysis Unit
- OptiVize Ophthalmic Forceps
For each, the letter says the product is adulterated under section 501(f)(1)(B) of the Act and misbranded under section 502(o), because it is being marketed for a use different from the legally marketed generic type, without the premarket notification the agency says is now required. FDA’s closing request is that BlephEx “cease any activities that result in the misbranding or adulteration” of the three devices, “such as the commercial distribution of the device for the uses discussed above.”
The sponge, and who it is sold for
The letter recites a 2017 section 513(g) response that treated an “Eyelid Cleaning Product” as a class I, 510(k)-exempt device for eyelid cleaning and hygiene, “not for the cure, treatment or mitigation of any disease or condition.” FDA says the firm is now marketing the sponge “for use in treating the symptoms of blepharitis, dry eye disease, and for pre-cataract and pre-LASIK patients.” That, the letter says, exceeds the exemption limits at 21 CFR 878.9(a).
FDA then states a safety concern about those groups, in the agency’s words:
Patients with dry eyes and blepharitis conditions, particularly in severe cases, often have highly inflamed skin and friable (fragile and easily damaged) tissue, making them more susceptible to tissue injury or post treatment reaction.
In patients with surgical wounds, the letter says, injury or infection “could provide a pathway for microbes to enter the eye or under a surgical flap, risking severe vision loss and ocular damage.”
The OptiVize unit and forceps
FDA says the electrolysis unit is marketed for a different intended use, a different technology, and a different mode of action than the generic ophthalmic electrolysis unit at 21 CFR 886.4250 — including claims about destroying biofilm in ocular hair follicles and delivering “a precise harmonic waveform.” The letter says that exceeds the exemption limits at 21 CFR 886.9(a) and 886.9(b).
The forceps, FDA says, are marketed to clear meibomian glands using heat and vibration, a different intended use and mode of action than a manual ophthalmic surgical instrument at 21 CFR 886.4350, and therefore not 510(k)-exempt under 21 CFR 886.9(a).
Smoke, a charger swap, and no report
Separately, the letter says the firm discovered that a BlephEx handpiece or its “Type G” charger “emitted smoke or blew up.” In October 2024, FDA writes, the firm sent USB-A chargers to a distributor with instructions to stop using the original Type G assemblies. “FDA has determined that a handpiece or charger smoking or blowing up presents a risk to health.” The required report of correction or removal under 21 CFR 806.10 had not been submitted as of May 8, 2026, the letter says. FDA treats that failure as misbranding under section 502(t)(2).
The letter also says BlephEx did not submit unique-device-identifier information to GUDID for any of the three devices, though FDA determined the firm is a “labeler” under 21 CFR 830.3.
Complaints, and a repeat
On the quality system, FDA says the complaint-handling procedure was “inadequate and not fully implemented” for “one hundred and seventy-seven plus (177+) complaints” on the sponge. The complaint log, the letter says, is an uncontrolled record; the vice president of operations “confirmed that no detailed complaint records existed for each of the 177+ complaints.” Examples quoted in the letter include handpieces that “blew up” or “began smoking,” marked “not evaluated for reportability.”
FDA’s assessment of the firm’s later responses is blunt: the firm “failed to investigate serious device malfunctions, and failed to report potentially life-threatening events to FDA in a timely manner.” Immediately after the complaint findings, the letter states: “This is a repeat violation cited on the Form FDA 483, issued for the previous March 27–28, 2019 inspection.”
The rest of the quality system
The letter stacks further observations, all framed as adulteration under section 501(h) for failure to follow current good manufacturing practice:
no CAPA opened since August 2023 despite handpieces that overheated, smoked, or “blew up”; no design-control procedures for any of the three devices, which the firm “continues to dispute” are required; no quality agreement, for months after the inspection, covering a lid cleanser “placed in or near patients’ eyes”; no device history records; a quality-system officer who, FDA says, had no training on those procedures for 26 months; and no internal quality audit in more than 27 months.
FDA reviewed six written responses from the firm, dated December 2025 through May 2026, and called them not adequate.
What the letter asks next
FDA gave fifteen business days from receipt for a written response, with documentation of corrections that “must address systemic problems.” Failure to address the matter, the letter says, “may result in regulatory action being initiated by the FDA without further notice,” including “seizure, injunction, and civil money penalties.” The letter also notes that other federal agencies may take warning letters into account when awarding contracts, and that PMA approvals and certificates to foreign governments may be withheld while the violations stand.
The source is the official FDA page:
fda.gov — BlephEx, LLC — 725861 — 06/03/2026
These notes paraphrase and quote one public manufacturer letter. They are not legal advice. A warning letter is an administrative notice, not a court judgment. Redaction marks such as (b)(4) are FDA’s.