Pro-Optics, LLC

WARNING LETTER
CMS # 739966

October 5, 2026

Dear Mr. Nyman:

During an inspection of your firm located in Palatine, Illinois from March 3, 2026 through March 11, 2026, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures Tight Top Contact Lens Cases and Flip Top Contact Lens Cases. 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
Our inspection and review of your website, www.proopticsgroup.com, determined that the Tight Top contact lens case and the Flip Top contact lens case are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because you do 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). The Tight Top contact lens case and the Flip Top contact lens case are also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), because you did not notify the agency of your intent to introduce or deliver for introduction the devices into commercial distribution, in that a notice or other information respecting the modifications to the devices was not provided to the FDA as required by section 510(k) of the Act, 21 U.S.C. § 360(k), and 21 C.F.R. 807.81(a)(3)(i).

A device that is currently in commercial distribution that has been significantly changed or modified in design, components, method of manufacture, or intended use requires a premarket notification submission; significant changes or modifications include a change or modification in the device that could significantly affect the safety or effectiveness of the device, e.g., a significant change or modification in design, material, chemical composition, energy source, or manufacturing process. 21 CFR 807.81(a)(3)(i).

Specifically, you modified the Tight Top contact lens case and the Flip Top contact lens case, cleared under K875197, by changing the polymers and colorants used in their manufacturing. The materials currently used in the Tight Top contact lens case ((b)(4)) and the Flip Top contact lens case ((b)(4)) represent a significant material deviation from the devices cleared under K875197, which specified the use of (b)(4) ((b)(4)). These are significant changes to the material of the devices that could significantly affect their safety or effectiveness.

Furthermore, the clearance under K875197 specifies four colors: (b)(4) grey, (b)(4) white, (b)(4) blue, and (b)(4) aqua. Your firm’s introduction of additional, uncleared colorants (including red, magenta, green, yellow, orange, orange, purple, and black) for the Tight Top contact lens case and the Flip Top contact lens case introduces unreviewed biocompatibility risks. These are significant changes to the chemical compositions of the devices that could significantly affect their safety or effectiveness.

Because the FDA has not evaluated these material and colorant modifications, the safety and effectiveness of the redesigned Tight Top Contact Lens Cases and Flip Top Contact Lens Cases have not been established.

Quality Management 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 Management System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. These violations include, but are not limited to, the following:

1. Failure to document procedures for design and development, as required by ISO 13485:2016, Clause 7.3.1. Specifically, your firm failed to document procedures for design and development, including design and development: inputs, outputs, review, verification, validation, transfer, and control of changes for the Pro Optics Tight Top and Flip Top Contact Lens Cases. For example,

a) Your firm does not have documented design and development procedures. During the inspection, you acknowledged that your firm does not have documented design and development procedures and you could not provide required design and development records upon request.
b) Your firm does not have documented design and development transfer procedures. During the FDA inspection you stated that your firm does "not have documented evidence of proper transfer of design output information from the previous owner" to manufacturing.
c) The design modifications were not subject to control of design and development changes prior to implementation. During the inspection you stated that "these design modifications were not subjected to the required review and approval processes prior to implementation." Your firm failed to document the control of design and development changes or evaluate the effect of these modifications on the finished device.
d) Your firm has not maintained design and development output records, including design drawings. When these records were requested during the inspection, you stated, "We don't have device drawings" and indicated that you would "document and maintain those for future inspections." Without maintained design and development output records constituting the medical device file, your firm cannot demonstrate that manufactured devices meet design specifications and design and development input requirements or intended use.

Since January 1, 2024, your firm has manufactured approximately (b)(4) Pro Optics Tight Top Contact Lens Cases and (b)(4) Flip Top Contact Lens Cases, for the storage, disinfection, and cleaning of contact lenses.

2. Failure to control or evaluate changes to quality management system processes for their impact on the quality management system and on medical devices produced, as required by ISO 13485:2016, Clause 4.1.4. Specifically, your firm's Change Control Procedure (SOP 2.4, Section 5.0, Rev. 1.30, Eff. Date August 28, 2020) requires that "changes to production processes are documented on the change control form." Your firm failed to document the change from contract manufacturer (b)(4) to (b)(4) manufacturing via (b)(4) molding, which occurred on January 8, 2021. Furthermore, your firm did not evaluate the impact of this manufacturing change on the devices produced and the process controls necessary to address potential risks to product quality and end users. During the inspection you stated that "an impact assessment was not conducted to evaluate effects on the quality management system and device quality."

We are unable to determine the adequacy of your corrective actions as your firm has not provided a response to the observations.

This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. 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.

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 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 FD&C Act, include your reasoning and any supporting information for our consideration as part of your response.

Your firm’s response should be sent via email to Melissa Michurski, Establishment Assessment Team 2, Assistant Director, at CDRHEnforcement@fda.hhs.gov. Please include in the subject line, “CMS Case #739966” when replying. If you have any questions about the contents of this letter, please contact: Rafael Padilla, Compliance Officer at Rafael.Padilla@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 determine the causes of any violations and take prompt actions to address any violations and bring the products into compliance.

Sincerely,
/S/

Barbara C. Marsden
Director
Office of Regulatory Programs
Office of Product Evaluation and Quality
Center for Devices and Radiological Health