Understanding the Manufacturing Process of Eye Drops and How Contamination Can Occur

The U.S. Food and Drug Administration (FDA) has recently identified several brands of eye drops that were sold with contaminants. These contaminants—which were introduced into the affected eye drops during the manufacturing process—present serious risks for users, including the risk of life-altering or even life-threatening bacterial infections.

This raises an important question: Why is this the case? Why have multiple companies recently sold contaminated eye drops—particularly when FDA regulations exist specifically to ensure that this does not happen?

How Eye Drops Become Contaminated

In order to understand the answers to these questions, we have to examine the manufacturing process for eye drops. Companies typically manufacture eye drops in large facilities that also manufacture numerous other types of products. While some of these facilities are set up to meet the FDA’s requirements and ensure compliance with the Current Good Manufacturing Practice (CGMP) regulations, others are not.

To manufacture eye drops for sale in retail stores and online, companies use automated machines to mix the various formulas that they sell. Machines then pour the eye drops into bottles, which are then sealed (also using a mechanical process in most cases). Throughout this entire process the eye drops are supposed to remain in a sterile environment, as the FDA explains:

“These products are intended to be sterile. Ophthalmic drug products [such as eye drops] pose a potential heightened risk of harm to users because drugs applied to the eyes bypass some of the body’s natural defenses.”

Contamination occurs when a flaw in the manufacturing process compromises eye drops’ sterility. In the recent recalls, we have seen two primary issues that have resulted in the large-scale sale of contaminated eye drops:

• Failure to Maintain Adequate Sterilization During Manufacturing – In many cases, eye drops become contaminated during the manufacturing process. Companies fail to take the necessary steps to ensure that their manufacturing facilities are sterile, and this allows contaminants to get into their eye drop formulas before the eye drops are packaged for sale.
• Using Compromised Bottles or Lids to Package Eye Drops – There have also recently been cases of companies selling eye drops in unsafe packaging. If an eye drop bottle or lid is compromised, harmful bacteria can get into the bottle while in storage or in transit to pharmacies.

Another reason for the large-scale contamination issues is that companies often buy eye drops from the same manufacturing facility and then resell them under their own brand. For example, retailers like CVS, Rite Aid and Target don’t have facilities to manufacture their own store brand eye drops. Instead, they buy eye drops in bulk (at a discounted price) and then affix their own labels before selling them to the public. As a result, issues at one manufacturing facility can affect multiple brands—and that is exactly what we are seeing with many of the contaminated eye drops that have been sold over the past year.

Compliance with the FDA’s Current Good Manufacturing Practice (CGMP) Regulations is Critical

The FDA’s Current Good Manufacturing Practice (CGMP) regulations are one of the most important sources of protection for consumers who purchase eye drops and other medical products. While manufacturers must comply with numerous laws and regulations, the CGMP regulations establish clear, specific and extensive safeguards that are designed to prevent contamination and other similar types of issues. As the FDA explains:

“Adherence to the CGMP regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations. This includes establishing strong quality management systems, obtaining appropriate quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing laboratories. . . .

“A consumer usually cannot detect (through smell, touch, or sight) that a drug product is safe or if it will work. . . . Therefore, it is important that drugs are manufactured under conditions and practices required by the CGMP regulations to assure that quality is built into the design and manufacturing process at every step.”

As a result, failure to comply with the CGMP when manufacturing eye drops and other medical products is a big deal. It can expose consumers to substantial risks—including risks from which they may never recover. In the case of contaminated eye drops, the FDA has determined that manufacturers’ failure to adhere to the CGMP has resulted in the introduction of harmful bacteria including (but not limited to):

• Alpha Streptococcus
• Bacillus SPP
• Coagulase Negative Staphylococcus
• Haemophilus
• Pseudomonas Aeruginosa (P. aeruginosa)
• Serratia SPP
• Staph Aureus

These bacteria can be extremely dangerous. For example, the FDA and U.S. Centers for Disease Control and Prevention (CDC) have linked an outbreak of P. aeruginosa to contaminated eye drops. During the outbreak, which began in 2023, the CDC has identified at least 81 cases of P. aeruginosa infections, representing a 16-percent increase over the prior period. According to the CDC, P. aeruginosa infections linked to contaminated eye drops have caused at least 14 cases of vision loss, four surgical eye removals and four premature deaths.

These are just the reported adverse outcomes linked to one of the many forms of harmful bacteria found in contaminated eye drops.

With this in mind, anyone who has concerns about the safety of their eye drops should check the FDA’s recall alerts, and they should see their doctor promptly if they are experiencing eye pain, blurred vision, discharge or any other possible symptoms of a bacterial infection. Those who are diagnosed with infections should also consult with an attorney about their legal rights. Companies that sell contaminated eye drops can be held liable for users’ financial and non-financial losses, and individuals and families across the country are actively pursuing claims for just compensation.

Speak with a Lawyer About Filing a Claim for Contaminated Eye Drops

If you would like to know more about filing a claim for an infection caused by contaminated eye drops, we invite you to get in touch. To speak with a lawyer about your legal rights in confidence, please call 800-780-8607 or request a free consultation online today.