BlephEx(MARCS-CMS 725861)

June 3, 2026

WARNING LETTER
CMS #725861

Dear Dr. Rynerson:

During an inspection of your firm located in Brentwood, TN from October 30, 2025, through November 19, 2025, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the BlephEx Powered Eyelid Cleaning Sponge, the OptiVize Ophthalmic Battery-Powered Electrolysis Unit, and the OptiVize Ophthalmic Forceps. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.

Unapproved Device Violations

Based on our review of the evidence collected during the inspection, your firm’s responses dated December 12, 2025, January 30, 2026, February 27, 2026, March 31, 2026, April 30, 2026, and May 29, 2026, and your firm’s website, www.blephex.com, we determined that the following products are adulterated and misbranded. Specifically:

The BlephEx Powered Eyelid Cleaning Sponge is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g) for the device as described and marketed. The BlephEx Powered Eyelid Cleaning Sponge is also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm introduced or delivered for introduction this device into interstate commerce for commercial distribution, intended for a use different from the intended use of a legally marketed device in the generic type of device described at 21 CFR 878.4820 without submitting a premarket notification to FDA as required by section 510(k) of the Act, 21 U.S.C. § 360(k), and 21 CFR 807.81(a).

On July 7, 2017, your firm submitted a request to FDA for information regarding your “Eyelid Cleaning Product” under section 513(g) of the Act. In that request, your firm proposed, in part, that the Eyelid Cleaning Product be regulated under 21 CFR 878.4820 as a class I device exempt from 510(k) notification, specifying an indication for a “battery-operated [eyelid cleaning] device intended to provide power to operate a spinning micro-sponge that cleans the eyelids”. Your firm described the Eyelid Cleaning Product for “eyelid cleaning/hygiene, and not for the cure, treatment or mitigation of any disease or condition. The purpose of the eyelid cleaning product is to maintain hygiene as part of a healthy lifestyle that may help to reduce the risk of blepharitis and dry eye.” Further, your firm stated that the Eyelid Cleaning Product is not intended to be used as a treatment.

On September 11, 2017, FDA responded to your firm. Based on the information provided, FDA believed that the Eyelid Cleaning Product falls within 21 CFR 878.4820, Surgical instrument motors and accessories/attachments (product code PYU) as a class I device exempt from premarket notification requirements of the Act, subject to the limitations under 21 CFR 878.9. The “Eyelid Cleaning Product” referenced in your firm’s July 7, 2017, correspondence has since been marketed as the BlephEx Powered Eyelid Cleaning Sponge.

However, there is evidence that the BlephEx Powered Eyelid Cleaning Sponge is intended for uses that are different from those of legally marketed devices classified under 21 CFR 878.4820. Generic devices of this type include surgical instrument motors and accessories that are ACpowered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. They also include dermabrasion devices that do not cut hard or soft tissues. Devices under product code PYU are used by healthcare professionals to perform in-office cleaning of the eyelid margins and eyelashes.

However, your firm is marketing the BlephEx Powered Eyelid Cleaning Sponge for use in treating the symptoms of blepharitis, dry eye disease, and for pre-cataract and pre-LASIK patients. Examples include the following videos from your firm’s website which instruct viewers to “[w]atch the following video to learn more about how the BlephEx® device is used in a professional clinical setting.” https://www.blephex.com/blephex-procedure.

• The BlephEx news story video describes the BlephEx Powered Eyelid Cleaning Sponge for “treating an irritating eye condition.” Further noting that, “[t]here is relief for people who suffer from blepharitis.” The video includes a testimonial from a patient diagnosed with blepharitis who is shown receiving a new “treatment option called BlephEx.”
  www.blephex.com/blephex-procedure

• In the BlephEx procedure video featuring you in your capacity as President of BlephEx, LLC, you recommend the BlephEx Powered Eyelid Cleaning Sponge for “dry eye and blepharitis patients” (0:20-0:21/18:07), further stating that the device is used for “opening up the meibomian glands, [which means] we have better oils, therefore better vision.” (0:54 to 0:58/18:07). You also explain that BlephEx Powered Eyelid Cleaning Sponge is “[a]lso, for pre-cataract and pre-LASIK patients” (0:48-0:49/18:07).
  www.blephex.com/blephex-procedure

Your firm appears to be marketing the BlephEx Powered Eyelid Cleaning Sponge device for use on specific vulnerable populations, including those with dry eye, blepharitis, pre-cataract, and pre-LASIK patients. Expanding the device's indications to these specific groups introduces significant, unverified safety concerns. Any eyelid procedure, including use of this device, risks inflammation, tissue injury, or abrasion around the eyelids. In patients with surgical wounds, these risks are compounded — potential eyelid 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. 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. These clinical concerns highlight that using this device on these specific populations carries unique risks that go beyond standard eyelid hygiene. Because there is evidence that the BlephEx Powered Eyelid Cleaning Sponge is intended for uses that are different from those of legally marketed devices classified under 21 CFR 878.4820, it exceeds the limitations described in 21 CFR 878.9(a) and is not exempt from premarket notification.

The OptiVize Ophthalmic Battery-Powered Electrolysis Unit is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g) for the device as described and marketed. The OptiVize Ophthalmic Battery-Powered Electrolysis Unit is also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm introduced or delivered for introduction this device into interstate commerce for commercial distribution, intended for a use different from the intended use of a legally marketed device in the generic type of device described at 21 CFR 886.4250, Ophthalmic electrolysis unit, without submitting a premarket notification to FDA as required by section 510(k) of the Act, 21 U.S.C. § 360(k), and 21 CFR 807.81(a).

Devices classified under 21 CFR 886.4250, Ophthalmic electrolysis unit, are exempt from premarket notification unless they exceed the limitations on exemption at 21 CFR 886.9(a). However, there is evidence that the OptiVize Ophthalmic Battery-Powered Electrolysis Unit is intended for uses that are different from those of legally marketed devices classified under 21 CFR 886.4250. Generic devices of this type are intended to destroy ocular hair follicles by applying a galvanic electrical current. However, your firm is marketing the OptiVize Ophthalmic Battery-Powered Electrolysis Unit for a different intended use. Examples include:

• “…destruction of biofilm within ocular hair follicles” https://www.blephex.com/optivize

• “…blows biofilm off the inside of the tiny meibomian oil-making sacs, converting it into millions of tiny protein-polysaccharide particles that are then ready for the next step”
  www.blephex.com/product/optivize?p=LSomq8aij2hbmHFRi

• “…completely vaporize biofilm lurking in any structure within the eyelid”
  www.blephex.com/product/optivize?p=LSomq8aij2hbmHFRi

In addition, your firm is marketing the OptiVize Ophthalmic Battery-Powered Electrolysis Unit using different fundamental scientific technology. Examples include:

• “…delivers a precise harmonic waveform via a painless electric current to completely vaporize biofilm lurking in any structure within the eyelid”
  www.blephex.com/product/optivize?p=LSomq8aij2hbmHFRi

• “…utilizes heated expression forceps”
  www.blephex.com/product/optivize?p=LSomq8aij2hbmHFRi

The claims of “destruction of biofilm within ocular hair follicles” and “blows biofilm off the inside of the tiny meibomian oil-making sacs, converting it into millions of tiny protein-polysaccharide particles that are then ready for the next step” represent a different intended use from that of an Ophthalmic electrolysis unit under 21 CFR 886.4250. In addition, the OptiVize Ophthalmic Battery-Powered Electrolysis Unit uses a fundamental scientific technology different from that of an Ophthalmic electrolysis unit under 21 CFR 886.4250. Specifically, the Ophthalmic electrolysis unit under 21 CFR 886.4250 uses a galvanic electrical current, whereas the OptiVize unit delivers a precise harmonic waveform.

Lastly, the OptiVize Ophthalmic Battery-Powered Electrolysis Unit uses a mode of action different from that of the Ophthalmic electrolysis units. The OptiVize Ophthalmic Battery-Powered Electrolysis Units destroy hair follicles by inserting a needle into the meibomian gland and turning on a galvanic current. This passes an electrical current through the lash root to destroy the follicle. The OptiVize Ophthalmic Battery-Powered Electrolysis Unit delivers the harmonic waveform current through a specially designed eyelid shelf conduction plate. Because the OptiVize Ophthalmic Battery-Powered Electrolysis Unit is intended for uses that are different from those of legally marketed devices classified under 21 CFR 886.4250, it exceeds the limitations described in 21 CFR 886.9(a) and 21 CFR 886.9(b) and is not exempt from premarket notification.

The OptiVize Ophthalmic Forceps is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g) for the device as described and marketed. The OptiVize Ophthalmic Forceps is also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm introduced or delivered for introduction into interstate commerce for commercial distribution this device intended for a use different from the intended use of a legally marketed device in the generic type of device described at 21 CFR 886.4350 - Manual ophthalmic surgical instrument without submitting a premarket notification to FDA as required by section 510(k) of the Act, 21 U.S.C. § 360(k), and 21 CFR 807.81(a).

Devices classified under 21 CFR 886.4350 – Manual ophthalmic surgical instrument are exempt from premarket notification unless they exceed the limitations on exemption at 21 CFR 886.9(a).

However, there is evidence that the OptiVize Ophthalmic Forceps is intended for uses that are different from those of legally marketed devices classified under 21 CFR 886.4350 - Manual ophthalmic surgical instrument. Generic devices of this type are nonpowered, handheld devices intended to aid or perform ophthalmic surgical procedures. However, your firm is marketing the OptiVize Ophthalmic Forceps for a different intended use, namely, to clear the meibomian glands of sludge and accumulated bacteria and their inflammatory destructive toxins. Example includes:

• “VIBRATORY EXPRESSION - OptiVize utilizes heated expression forceps unlike anything on the market. Over the years, meibomian oil is acted upon by bacterial toxins and enzymatically converted into a more stable food source for themselves…a thickened obstructive paste or sludge. By adding vibration to the expression procedure, this sludge is now more effectively removed from inside the meibomian glands, along with accumulated bacteria and their inflammatory destructive toxins.”
  www.blephex.com/product/optivize?p=LSomq8aij2hbmHFRi

In addition, the OptiVize Ophthalmic Forceps use a mode of action different from that of a manual ophthalmic surgical instrument, namely, the OptiVize Ophthalmic Forceps uses heat and vibration for expression. The use of heat and vibration in the OptiVize Ophthalmic Forceps is an intended use different from that for manual ophthalmic surgical instruments under 21 CFR 886.4350; it therefore exceeds the limitations described in 21 CFR 886.9(a) and is not exempt from premarket notification.

For a device requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. § 360(k), is deemed satisfied when a PMA is pending before the agency. 21 CFR 807.81(b). The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.

Our office requests that BlephEx, LLC cease any activities that result in the misbranding or adulteration of the BlephEx Powered Eyelid Cleaning Sponge, OptiVize Ophthalmic Battery-Powered Electrolysis Unit, and OptiVize Ophthalmic Forceps, such as the commercial distribution of the device for the uses discussed above.

Corrections and Removals Violation

Our inspection also revealed that your firm’s BlephEx Powered Eyelid Cleaning Sponge devices are misbranded under section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that your firm failed or refused to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 806 – Medical Devices; Reports of Corrections and Removals. Significant violations include, but are not limited to, the following:

Failure to submit a Report required by 21 CFR 806.10 to FDA, within 10 working days of initiating the correction or removal. For example: you discovered that your BlephEx Powered Eyelid Cleaning Sponge handpiece or “Type G” charger in the (b)(4) or (b)(4) emitted smoke or blew up. To reduce the incidence of these problems, in October 2024 your firm sent USB-A chargers to your distributor in (b)(4) with instructions for distribution to their customers to discontinue use of the original Type G charger assemblies. FDA has determined that a handpiece or charger smoking or blowing up presents a risk to health.

This action is a medical device correction or removal initiated to reduce a risk to health posed by the BlephEx Powered Eyelid Cleaning Sponge device or to remedy a violation of the Act caused by the device which may present a risk to health, for which you are required to submit a Report of Correction or Removal to FDA. As of November 19, 2025, you did not submit a Medical Device Report of Correction or Removal to FDA for this action.

Your firm’s responses to the FDA-483, dated December 12, 2025, January 30, 2026, and February 27, 2026, are not adequate. The responses explain your action and include MDR Reports for those complaints. You have not submitted a Report of Correction or Removal to FDA as of May 8, 2026.

Submitting Required Information to GUDID

The Blephex Powered Eyelid Cleaning Sponge, the OptiVize Ophthalmic Battery-Powered Electrolysis Unit, and the OptiVize Ophthalmic Forceps are misbranded within the meaning of section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that there was a failure or refusal to furnish any material or information required by or under section 519 of the Act, 21 U.S.C. § 360i, respecting these devices. In particular, 21 CFR 801.20(a) requires, with exceptions not relevant here, that the label and device package of every medical device bear a unique device identifier (UDI) that meets the requirements of 21 CFR Part 801, subpart B, and 21 CFR Part 830. Also, 21 CFR 830.300(a) and 830.320(b) – both of which were promulgated under section 519 of the Act, among other provisions – require that the labeler of a device submit electronically to FDA’s Global Unique Device Identification Database (GUDID) the information required by 21 CFR Part 830, subpart E, for each version or model required to bear a UDI.

FDA has determined that BlephEx, LLC is a “labeler” within the meaning of 21 CFR 830.3 and has not submitted to GUDID information required by 21 CFR Part 830, subpart E, respecting these devices. BlephEx, LLC causes labels to be applied to these device with the intent that they will be commercially distributed without any subsequent replacement or modification of the label and/or causes the labels of these devices to be replaced or modified with the intent that the devices will be commercially distributed without any subsequent replacement or modification of the label (except that the addition of the name of, and contact information for, a person who distributes the device, without making any other changes to the label, is not a modification for the purposes of determining whether a person is a labeler).

The failure or refusal to furnish any notification or other material or information required by or under section 519 of the Act, 21 U.S.C. § 360i, also constitutes a prohibited act under section 301(q)(1)(B) of the Act, 21 U.S.C. § 331(q)(1)(B).

Quality System Regulation Violations

This inspection also revealed that these devices are adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. We received responses from Ryan J. Peterson, Vice President, Operations dated December 12, 2025, January 30, 2026, February 27, 2026, March 31, 2026, April 30, 2026, and May 29, 2026, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, that was issued to your firm. We address the responses below, in relation to each of the noted violations. The violations found during the inspection include, but are not limited to, the following:

1. Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit as required by 21 CFR 820.198(a). Specifically, your firm's Complaint Handling Procedure, Complaint RMA Procedure, Revision 01, is inadequate and not fully implemented for the review, evaluation, and investigation of one hundred and seventy-seven plus (177+) complaints received involving the BlephEx Powered Eyelid Cleaning Sponge product. For example:

a) Your firm did not ensure complaints are processed in a uniform and timely manner, as required by 21 CFR 820.198(a)(1). Your firm's Complaint Log, used as the primary document to record complaints received by your firm, is an uncontrolled record that is
omitted from your firm's complaint handling procedure. The log records 177+ complaints as opened but does not document when the complaints are closed, as required by Section 6.17 of your firm's complaint procedure.

b) Your firm does not maintain and make it readily available for review the BlephEx Complaint RMA forms, required by Section 6.2 of your firm's complaint procedure, to capture detailed information for complaints received by your firm [21 CFR 820.198(a)(2)]. During the inspection, your firm’s VP of Operations confirmed that no detailed complaint records existed for each of the 177+ complaints received.

c) Your firm's complaint procedure does not require documentation of the rationale and responsible party when investigations are not conducted, as required by 21 CFR 820.198(b). Your firm’s VP of Operations maintains the Complaint Log as the only record of complaints received by your firm. This log lacks evidence of review and evaluation to determine whether investigations are needed. None of the 177+ complaints include justification for decisions not to investigate or identification of responsible individuals.

d) None of the 177+ complaints documented in your firm’s Complaint Log are documented as reviewed, evaluated, investigated, or maintained in a separate complaint file for MDR reporting, as required by 21 CFR 820.198(d). Your firm's complaint procedure, Section 6.15, requires all complaints that represent a reportable event under the MDR regulation must be promptly reviewed, evaluated, and investigated by a designated individual and maintained in a separate complaint file. Specific examples that fail to comply with this requirement included:

i) Serial Number (b)(4) (9/9/2024): handpiece "blew up" - not evaluated for reportability
ii) Serial Number (b)(4) (2/14/2025): handpiece "blew up" - not evaluated for reportability
iii) Serial Number (b)(4) (1/21/2025): handpiece "began smoking" - not evaluated for reportability

This is a repeat violation cited on the Form FDA 483, issued for the previous March 27–28, 2019 inspection.

We reviewed your firm's responses and concluded they are not adequate. Your firm failed to review and evaluate 100% of complaints over a (b)(4) failed to investigate serious device malfunctions, and failed to report potentially life-threatening events to FDA in a timely manner—these concerns have not been adequately addressed through your corrective actions, and you have not demonstrated that your quality system can now reliably identify, investigate, and report device-related safety issues as required by 21 CFR 820.198 and 21 CFR Part 803.

Your responses indicate implementation of a new Complaint Handling Procedure (CAPA-102-01) and Medical Device Reporting Procedure (CAPA-103-01) and completion of associated training, yet critical deficiencies remain unaddressed 191 days after the inspection closeout. Your April 30, 2026, fourth update indicated that complaint investigations and complaint file remediation had been completed as of April 30, 2026. Your May 29, 2026, fifth update provides no new information and confirms only that all action items from the fourth update remain in progress. You have not provided documentation of the review results, investigation findings, or remediated complaint files to demonstrate what corrective actions were taken, how many additional reportable events were identified beyond the original three, whether additional MDRs were submitted, or how complaint files were remediated to meet regulatory requirements. CAPAs 26-001 and 26-002 remain in the implementation phase with no details provided regarding root cause findings or specific corrective actions being implemented. You have not provided evidence that your new complaint handling procedures are being implemented in practice for newly received complaints, such as sample complaint records created using the new Complaint Form (CF-111-01), documentation of MDR evaluations being performed, or evidence that investigations are being conducted with appropriate justifications when not required.

2. Failure to establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a), and failure to document corrective and preventive action activities and results, as required by 21 CFR 820.100(b). Specifically, your firm's Corrective and Preventive Action Procedure, CAPA-101-01, has not been implemented for the issuance, logging, tracking, and execution of corrective and preventive actions (CAPAs), as required by the procedure. Your firm failed to analyze 177+ complaints received between (b)(4) involving the BlephEx Powered Eyelid Cleaning Sponge product, as documented in your firm's Complaint Log, which included failures of the "handpiece" that overheated, smoked, or "blew up." During the inspection, your firm's VP of Operations confirmed that no CAPA had been opened since August 2023 and was unaware of any CAPAs that had been opened prior to that date. The VP of Operations acknowledged that your firm did not follow its written CAPA procedure, which requires documentation of investigations per Section 6.5, verification or validation of corrective actions per Section 6.8, and other CAPA activities, and indicated to our investigator an unawareness of your firm's CAPA procedure until the inspection was pre-announced. For example, your firm failed to open a CAPA per your CAPA procedure, Sections 2., 6.1., and 6.1.6., to investigate the root cause, document the corrective action taken, and verify or validate that the corrective action was effective and did not adversely affect the finished device. Your firm replaced (b)(4) Type G power chargers with USB-A chargers in October 2024 in response to handpiece failures; however, your firm did not document this corrective action, did not conduct and document a root cause investigation to determine why the chargers failed, and did not verify or validate that the replacement chargers addressed the underlying problem or were safe and effective before distributing them to customers.

We reviewed your firm's responses and concluded they are not adequate. Your firm failed to document any CAPA activities despite serious device malfunctions requiring investigation, corrective action, and verification—these concerns have not been adequately addressed, and you have not demonstrated that your quality system can now reliably identify, investigate, correct, and prevent recurrence of quality problems as required by 21 CFR 820.100.

Your responses indicate implementation of a new Corrective and Preventive Action Procedure (CAPA-101-01) on December 11, 2025, and completion of associated training, yet critical deficiencies remain unaddressed 191 days after the inspection closeout. CAPA 26-003, which you committed to open on your December 12, 2025, initial response to investigate the root cause of your failure to document CAPA activities and results, was not opened until February 22, 2026 — 95 days after the inspection closeout. Your April 30, 2026, fourth update indicated CAPA 26-003 had advanced to the effectiveness monitoring phase. Your May 29, 2026, fifth update provides no new information and confirms only that all action items from the fourth update remain in progress, with no update to CAPA 26-003's status, findings, or effectiveness monitoring results provided. You have not provided any retrospective CAPA documentation for the handpiece failures documented in your Complaint Log, where devices overheated, smoked, or "blew up" between (b)(4).  Specifically, you have not provided a documented investigation into the root cause of the Type G charger failures that resulted in handpiece malfunctions, nor have you provided verification or validation that the USB charger replacement implemented in October 2024 is effective and safe. Your firm replaced (b)(4) Type G chargers in October 2024, yet as of May 29, 2026 — approximately 19 months after this corrective action and 191 days after the inspection closeout — you have not demonstrated through CAPA documentation that the root cause of the handpiece failures was properly investigated, that your corrective action addresses the root cause, or that the replacement chargers have been verified or validated to ensure they are safe, effective, and do not adversely affect the finished device. You have not provided evidence that your new CAPA procedure is being implemented in practice, such as sample CAPA records demonstrating that quality data from your 177+ documented complaints is being analyzed to identify nonconforming products or quality problems, or that CAPAs are being opened appropriately for ongoing quality issues.

3. Failure to establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met, as required by 21 CFR 820.30(a), and failure to establish and maintain procedures for the identification, documentation, validation or verification, review, and approval of design changes before their implementation, as required by 21 CFR 820.30(i). Specifically, your firm has not established and does not maintain design control procedures, as required by 21 CFR 820.30(a). During the inspection, your firm's VP of Operations confirmed that your firm does not have design control procedures for the BlephEx Powered Eyelid Cleaning Sponge, the OptiVize Ophthalmic Battery-Powered Electrolysis Unit, and the OptiVize Ophthalmic Forceps, to control the design of the devices to ensure that specified design requirements are met.

Your firm's VP of Operations also confirmed that your firm does not have design change control procedures to document, verify or validate, review, and approve design changes before implementation, as required by 21 CFR 820.30(i). Your firm changed the power chargers for the BlephEx Powered Eyelid Cleaning Sponge product from Type G plugs to USB-A configuration in October 2024. Your firm did not verify or validate that the change addressed the underlying problem that caused the "handpiece" to overheat, smoke, or "blow up", as documented in the Complaint Log, and did not verify that the design change did not adversely affect the finished device before implementing the change and distributing (b)(4) replacement chargers to customers. Your firm’s VP of Operations acknowledged to our investigator that the change was agreed upon by your firm’s management and your firm's supplier, and that your supplier made the changes to the device but could not produce written documentation of any communications or correspondence regarding this design change.

We reviewed your firm's responses and concluded they are not adequate. Your firm's lack of design control procedures and design change control procedures and lack of documented or validated design changes affecting device safety remain unaddressed.

Your firm continues to dispute that design control procedures are required for the BlephEx Powered Eyelid Cleaning Sponge, the OptiVize Ophthalmic Battery-Powered Electrolysis Unit, and the OptiVize Ophthalmic Forceps. However, as outlined above, we have determined and provided rationale that the devices are not Class I, 510(k)-exempt devices and therefore are subject to design control requirements under 21 CFR 820.30(a)(1). Your May 29, 2026, fifth update provides no new information and confirms only that all action items from the fourth update remain in progress, with no evidence provided that design control or design change control procedures have been established, that Design History Files have been created, or that website revisions have been documented. Your firm has not established design change control procedures as required by 21 CFR 820.30(i). Your firm made a design change from Type G to USB chargers for the BlephEx Powered Eyelid Cleaning Sponge in October 2024 in response to serious device malfunctions documented in your Complaint Log, yet you did not document this design change, did not verify or validate the change before implementation, and did not establish procedures for the identification, documentation, validation or verification, review, and approval of design changes before their implementation. As of May 29, 2026, 191 days after the inspection closeout and approximately 19 months after implementing the charger design change, you have not provided documentation or validation of this change, leaving unresolved questions about whether the replacement chargers adequately address the root cause of the failures and whether they are safe and effective.

4. Failure to adequately establish and maintain the requirements, including quality requirements, that must be met by suppliers, contractors, and consultants, as required by 21 CFR 820.50(a). Specifically, your firm's Supplier Qualification Procedure, RAQA-101-01, has not been implemented. Your firm manufactures, promotes, and distributes the BlephEx Powered Eyelid Cleaning Sponge and bottle(s) of BlephEx Lid Cleanser used exclusively with the BlephEx handpiece and manufactured by your firm's contract manufacturer. Your firm's supplier qualification procedure, Section 6.7.1, requires that to qualify a contract manufacturer, the supplier file must contain, at a minimum, a Quality Agreement. Your firm's VP of Operations stated that your firm had no quality agreement for the manufacturer of the BlephEx Lid Cleanser. The VP of Operations acknowledged that your firm was not following its Supplier Qualification Procedure.

We reviewed your firm's responses and concluded they are not adequate. Your firm's lack of defined controls over a product distributed with your medical device remains unresolved, and you have not provided evidence of compliance with 21 CFR 820.50(a)(2) or your own supplier qualification procedures and newly implemented Purchasing and Supplier Management Procedure.

Your firm committed to entering into a supplier agreement with the manufacturer of the BlephEx Lid Cleanser by February 28, 2026. Your February 27, 2026, second update indicated this action remained "in progress" one day before the deadline. Your March 31, 2026, third update indicated the supplier agreement remained "in progress," 31 days after the missed deadline. Your April 30, 2026, fourth update indicated the supplier agreement was completed on April 29, 2026, 60 days after your missed deadline and 162 days after the inspection closeout. Your May 29, 2026, fifth update provides no new information and confirms only that all action items from the fourth update remain in progress. You have not provided a copy of the executed supplier agreement or evidence demonstrating how you now ensure that the BlephEx Lid Cleanser is being produced correctly and reproducibly under adequate quality controls, or how you control the responsibilities between your firm and the manufacturer. Your firm implemented a new Purchasing and Supplier Management Procedure (QM-02-010-02) on February 26, 2026, which requires Quality Agreements for high-risk suppliers, including contract manufacturing suppliers performing product realization operations, yet you did not establish a quality agreement with the BlephEx Lid Cleanser manufacturer until 60 days after your committed deadline. Your firm has distributed the BlephEx Lid Cleanser with your devices for more than six months after the inspection without adequate quality controls over a product placed in or near patients' eyes.

5. Failure to establish and maintain procedures to ensure that device history records (DHRs) for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the device master record (DMR) and the requirements of this part, as required by 21 CFR 820.184. Specifically, your firm has not established and does not maintain DHR procedures and records for BlephEx Powered Eyelid Cleaning Sponge the OptiVize Ophthalmic Battery-Powered Electrolysis Unit, and the OptiVize Ophthalmic Forceps. During the inspection, your firm’s VP of Operations confirmed that your firm did not have DHR procedures or the DHRs for the BlephEx and OptiVize devices manufactured and distributed.

We reviewed your firm's responses and concluded they are not adequate. As of March 31, 2026, you have not demonstrated compliance with 21 CFR 820.184 requirements for device history records, have not verified through audits that your contract manufacturers are maintaining adequate DHRs, and have not provided evidence that you can access DHRs when needed for complaint investigations, MDR evaluations, or quality system oversight.

Your responses indicate implementation of a new Purchasing and Supplier Management Procedure (QM-02-010-02) on February 26, 2026, and completion of associated training, yet critical deficiencies remain unaddressed 191 days after the inspection closeout. Your April 30, 2026, fourth update confirmed that your firm is no longer using the services of one of your contract manufacturers. Your May 29, 2026, fifth update provides no new information and confirms only that all action items from the fourth update remain in progress. The review and update of the Supplier Quality Agreement with your active contract manufacturer remains "in progress," 90 days after your missed self-imposed deadline of February 28, 2026, and 191 days after the inspection closeout, with no updated agreement provided. CAPA 26-004 remains in the investigation phase with no details provided regarding investigation findings or determination of possible root cause. Your audits of your contract manufacturer remain "in progress," 59 days after the target completion date of March 31, 2026, with no audit reports, findings, or verification that the manufacturers are maintaining adequate Device History Records provided. You have not provided sample DHRs to demonstrate that these records exist and contain the required information specified in 21 CFR 820.184 or are accessible to your firm. Your new Purchasing and Supplier Management Procedure addresses supplier management generally but does not establish your firm's own procedures for ensuring DHRs are maintained and accessible, does not specify what DHR information your firm must obtain and maintain, and does not address how you will verify that devices are manufactured in accordance with specifications, particularly given the serious BlephEx handpiece malfunctions documented in your Complaint Log.

6. Failure to establish and maintain procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities, as required by 21 CFR 820.25(b). Specifically, during the inspection, your firm’s VP of Operations confirmed that your firm did not have a training procedure and did not have training records. The VP of Operations affirmed that prior to the inspection being preannounced, he was unaware of the firm's quality system, including the complaint handling procedure, CAPA procedure, and other quality system requirements, despite being responsible for overseeing the quality system since August 2023.

We reviewed your firm's responses and concluded they are not adequate. Your responses have not included competence assessments for personnel performing quality-critical functions, have not verified training effectiveness beyond attendance documentation, and have not demonstrated that trained personnel are now competently performing their assigned quality system responsibilities as required by 21 CFR 820.25(b). While your firm has demonstrated the ability to conduct and document training on procedures created after the inspection, you have not provided evidence of your firm's retroactive review of training to address the 26-month period (August 2023 through October 2025) during which your VP of Operations was responsible for your quality system without receiving any training on quality system requirements.

Your April 30, 2026, fourth update indicated CAPA 26-005 had advanced to the effectiveness monitoring phase 68 days after being opened on February 22, 2026. Your May 29, 2026, fifth update provides no new information and confirms only that all action items from the fourth update remain in progress, with no update to CAPA 26-005's effectiveness monitoring results, root cause findings, or corrective actions implemented provided. CAPA 26-005 was not opened until 95 days after the inspection closeout and, despite advancing to effectiveness monitoring, you have not provided determination of the possible root cause of why your VP of Operations, who was responsible for the quality system since August 2023, operated for 26 months without training on quality system requirements, directly contributing to the systemic failures documented across multiple observations. Your firm must provide evidence that personnel responsible for quality system functions possess the necessary competence through appropriate education, training, skills, and experience, and must verify that training provided has resulted in the ability to adequately perform assigned responsibilities.

7. Failure to establish procedures for quality audits and conduct such audits to assure that the quality system is in compliance with the established quality system requirements, as required by 21 CFR 820.22. Specifically, during the inspection, your firm's VP of Operations confirmed that your firm does not maintain established quality audit procedures for conducting quality audits. The VP of Operations also confirmed that your firm has not audited your firm's contract manufacturers, and that your firm's quality system has not been audited since your VP of Operations accepted the position with the company in August 2023 (27+ months prior).

We reviewed your firm's responses and concluded they are not adequate. Your firm has not conducted quality audits to verify compliance with established quality system requirements or determine the effectiveness of your quality system, as required by 21 CFR 820.22. This critical deficiency remains unresolved. You have not demonstrated that your quality system includes the oversight mechanism required by 21 CFR 820.22, to systematically identify and correct quality system deficiencies before they result in nonconforming products or regulatory violations.

Your responses indicate implementation of a Quality Audit Procedure (QM-02-024-01) on January 29, 2026, and completion of associated training, yet critical deficiencies remain unaddressed 191 days after the inspection closeout. Your April 30, 2026, fourth update indicated CAPA 26-006 had advanced to the implementation phase 68 days after being opened on February 22, 2026. Your May 29, 2026, fifth update provides no new information and confirms only that all action items from the fourth update remain in progress, with no audit schedule, audit reports, audit findings, investigation findings, root cause analysis, or specific corrective actions being implemented provided. Your audits of contract manufacturers remain "in progress," 59 days after the target completion date of March 31, 2026, and 191 days after the inspection closeout, with no audit reports, findings, or verification that the manufacturers are maintaining adequate quality systems or device history records provided. You have not conducted any internal audits of your quality management system 120 days after implementing the Quality Audit Procedure. You have not provided an audit schedule, audit reports, audit findings, or evidence that your quality audit procedure is being implemented in practice. Your firm has not verified through audits that your contract manufacturers are maintaining adequate quality systems, device history records, or conducting proper device testing despite the serious charger malfunctions documented in your Complaint Log that occurred in 2024 and 2025. The fundamental requirement of 21 CFR 820.22 to "conduct such audits" remains unmet.

Your firm should take prompt action to address any violations identified in this letter. Failure to adequately address this matter may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties.

Other federal agencies may take your compliance with the FD&C Act and its implementing regulations into account when considering the award of federal contracts. Additionally, should FDA determine that you have Quality Management System Regulation violations that are reasonably related to premarket approval applications for Class III devices, such devices will not be approved until the violations have been addressed. Should FDA determine that your devices or facilities do not meet the requirements of the Act, requests for Certificates to Foreign Governments (CFG) may not be granted.

Additionally, on February 2, 2024, the FDA issued a final rule amending the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) Regulation under 21 CFR 820 to align more closely with the international consensus standard for Quality Management Systems for medical devices used by many other regulatory authorities around the world. The revised Part 820, referred to as the Quality Management System Regulation (QMSR), became effective on February 2, 2026. Your most recent inspection on October 30, 2025, through November 19, 2025, was conducted pursuant to the QS Regulation, which was in effect at the time of the inspection. However, any corrective actions you propose, or implement must be pursuant to the QMSR requirements in effect as of February 2, 2026. For more information on the QMSR please refer to our frequently asked questions webpage: https://www.fda.gov/medical-devices/quality-system-qs-regulationmedical-device-current-good-manufacturing-practices-cgmp/quality-management-system-regulation-final-rule-amendin-gquality-system-regulation-frequently-asked.

Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to address the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (which must address systemic problems) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm's response should be comprehensive and address any violations included in this Warning Letter. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration as part of your response. 

Your firm's response should be sent to: Melissa Michurski, Assistant Director, at CDRHEnforcement@fda.hhs.gov. Refer to CMS# 725861 when replying. If you have any questions about the contents of this letter, please contact Salvatore Randazzo, Compliance Officer, at 407-475-4712 or salvatore.randazzo@fda.hhs.gov. 

Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm's facility. It is your firm's responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm' s manufacturing and quality management systems. Your firm should investigate and dete1mine the causes of any violations and take prompt actions to address any violations and bring the products into compliance. 

Sincerely, 
/S/ 
CDR Cesar A. Perez, PhD, USPHS 
Acting Deputy Director 
Office of Regulatory Programs 
Office of Product Evaluation and Quality 
Center for Devices and Radiological Health

CC: Ryan J. Peterson, VP of Operations, BlephEx, LLC, (b)(6)