FDA drafts guidance to improve hydrogen peroxide-based contact lens care product labeling
The US Food and Drug Administration has developed draft guidance for manufacturers of hydrogen peroxide-based contact lens care products (HPCP) to consider when labeling their solutions in response to a number of adverse events, including cases where consumers have lost their eyesight.On 17 August, FDA published a draft guidance titled, “Hydrogen Peroxide-Based Contact Lens Care Products: Consumer Labeling Recommendations - Premarket Notification (510(k)) Submissions.” The document comes more than five years after the agency convened its Ophthalmic Devices Panel and its Risk Communication Advisory Committee to discuss how to communicate potential HPCP risks.
“The safety and effectiveness of HPCPs when used as directed has been well established in the last few decades; however, FDA has become aware of an increase in the number of adverse event reports related to the misuse of these products,” the agency said. “Consumers have reported adverse events ranging from irritation to severe burning and stinging of the eyes and even blindness with the use of HPCPs.”
Like other lens care products, HPCPs can clean and disinfect contact lenses by breaking up and removing debris, protein, fatty deposits and microorganisms. However, unlike other solutions, HPCPs tend to be preservative-free, which means they can be used by people who have allergies or sensitivities to preservatives. While the products are generally considered to be low-risk, misuse of the product can have serious consequences.
The public meeting on HPCP in March 2017 covered several issues and the panel experts offered multiple suggestions to improve communication, including appropriate labeling and packaging, and clearly communicating risks of misuse of products. They emphasized that product labeling needs to be simple and clear in terms of warnings and use instructions, and that manufacturers need to ensure their HPCP bottles have red tips and caps to distinguish them more clearly from other lens cleaners.
In the proposed guidance FDA follows the advice of its advisory panel on the use red caps and tips, though the agency leaves some of the recommendations up to companies to decide whether to implement.
“Although not in the scope of this guidance, the panel also suggested making a change in the bottle shape, size, color, tactile features or other characteristics that would distinguish HPCPs from other contact lens care products that do not contain hydrogen peroxide,” the guidance said. “While FDA does not intend to recommend the type of bottle to be used to contain HPCP solutions, FDA recommends, to the extent possible, containers should appear distinct from those of multipurpose solutions or other products without hydrogen peroxide, which could minimize potential product selection errors and product misuse.”
FDA noted that the panel also called for manufacturers redesign and standardize HPCP labeling so they stand out from other products.
“Based on the adverse event reports and feedback obtained during the March 2017 panel meeting, device misuse may be exacerbated if the directions for use and warnings or precautions in the device labeling are not clear,” the agency noted. “FDA believes that these problems can be mitigated by emphasizing and simplifying important warnings and directions for use on the bottle and carton labeling for HPCP solutions … FDA believes the appropriate design and standardization of labeling would help inform consumers of device risks, thereby increasing the likelihood of appropriate device use and helping to mitigate against device misuse.”
The guidance goes on to make other recommendations such as making sure manufacturers include contraindications of HPCP products on their labeling as well as prominently displaying potential known hazards associated with the solutions.
“These warnings may alert consumers to the possibility of serious adverse reactions, situations which, if not avoided, could result in death or serious injury, and steps that should be taken if they occur,” said regulators. They added that general warnings should be prominently listed in all labeling types such as on the insert labeling, carton labeling and bottle labeling. Additional warnings, they added should be included in the package insert.
Additionally, FDA said that manufacturers should include non-product-specific warnings that state consumers should follow the direction of their eye care practitioner and all labeling instructions for proper use while also caring for the various components of the product, such as the lens case, or potentially face serious injury.
In terms of informing consumers about potential adverse reactions, FDA said that information should be on the package insert and list reactions associated with HPCPs such as corneal ulcers that may lead to vision loss. The agency also said that consumers should be advised to immediately remove their lenses if they feel any symptoms such as stinging and burning, eye discomfort, or excessive tearing.
“Statements should be added to the package insert advising the consumer on instructions for lens removal thereby reducing the potential for ocular damage,” FDA said. “The package insert labeling should also include statements that consumers immediately contact their eye care practitioner if problems persist or worsen, to seek immediate professional care, and to report all adverse events to the manufacturer.”
“A statement should be added to inform the consumer that they can also report adverse events to FDA Medwatch,” the agency added. “This is important to diagnose or document any adverse events associated with the product.”
The draft guidance also includes a glossary and appendices of label samples that manufacturers can use as a template for their products.
Stakeholders can comment on the draft guidance until 17 October on www.regulations.gov under docket no. FDA-2022-D-0986-0001.
