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Artificial tears brand name. Artificial Tears Recall: Understanding Eye Drop Safety and Alternatives

What brands of eye drops have been recalled by the FDA. How can consumers identify safe artificial tears for dry eye relief. What are the symptoms of eye infections caused by contaminated drops. How should patients properly use and store eye drops to prevent complications.

FDA Recalls Three Eye Drop Brands: What You Need to Know

The Food and Drug Administration (FDA) has recently issued recalls for three brands of eye drops, raising concerns among consumers about the safety of these widely used products. The recalls affect both over-the-counter and prescription eye drops, with varying reasons for their removal from the market.

EzriCare and DELSAM Pharma Artificial Tears

On February 2, 2023, the FDA warned consumers to stop using EzriCare Artificial Tears and DELSAM Pharma’s Artificial Tears due to potential bacterial contamination. These over-the-counter products have been linked to severe eye infections in 55 patients across 12 states, including California. Tragically, one death has been reported in connection with these infections.

The culprit behind these infections is a drug-resistant strain of bacteria called Pseudomonas aeruginosa. This aggressive pathogen can cause serious complications, including vision loss and systemic infections.

Brimonidine Tartrate Ophthalmic Solution

On March 1, 2023, Apotex Corp. initiated a voluntary recall of six lots of Brimonidine Tartrate Ophthalmic Solution, 0.15%. This prescription eye drop is commonly used to treat open-angle glaucoma and ocular hypertension. The recall was prompted by the discovery of cracks in the bottle caps, which could compromise the sterility of the product.

Purely Soothing 15% MSM Drops

The most recent recall, announced on March 3, 2023, involves two lots of Purely Soothing 15% MSM Drops. Pharmedica USA voluntarily recalled this over-the-counter product due to concerns about non-sterility. While no infections have been reported in connection with these drops, the potential risk to consumers prompted the recall.

Understanding the Risks of Contaminated Eye Drops

The recent recalls highlight the importance of using safe, sterile eye drops. Gary D. Novack, a clinical pharmacologist and professor at UC Davis Health, warns, “Using contaminated artificial tears increases the risk of eye infections that could result in blindness or serious illness.”

Eye infections can present with various symptoms, including:

  • Blurry vision
  • Discharge from the eye
  • Pain or discomfort
  • Redness of the eyelid or eye
  • A sensation of something in the eye
  • Increased sensitivity to light

If you experience any of these symptoms, it’s crucial to consult an eye care professional promptly.

The Importance of Artificial Tears in Treating Dry Eye Disease

Despite the recent recalls, artificial tears remain a crucial treatment for dry eye disease. Dr. Jeffrey H. Ma, an ophthalmologist at the UC Davis Eye Center specializing in ocular surface diseases, explains, “Dry eye disease is one of the most common eye diseases and can cause irritation, grittiness, redness, burning, tearing, and blurred vision. Artificial tears can help with these symptoms.”

Dry eye disease affects millions of people worldwide, and artificial tears provide much-needed relief for many patients. However, it’s essential to choose safe products and use them correctly to avoid complications.

Safe Alternatives for Dry Eye Relief

While the recent recalls may cause concern, there are still many safe options available for those suffering from dry eye. Dr. Ma recommends preservative-free artificial tears as a gentle and effective alternative.

“Preservative-free drops come in disposable single-use vials. So long as people do not touch the tip of the vial to their eyes or keep it for more than a day, preservative-free drops are safe and a great option for dry eyes,” he explains. These drops can be used more frequently throughout the day without causing irritation.

Proper Eye Drop Usage and Storage Guidelines

To ensure the safe use of eye drops and minimize the risk of infection, follow these guidelines:

  1. Wash your hands thoroughly before touching your eyes or applying eye drops.
  2. Check the expiration date on the product before use.
  3. Avoid touching the tip of the bottle or vial to your eye or any other surface.
  4. Use single-use vials only once and discard them after opening.
  5. Store eye drops according to the manufacturer’s instructions.
  6. Replace opened bottles of eye drops after the recommended period (usually 1-3 months).

Dr. Ma emphasizes, “Patients should not use eye-care products beyond the expiration date, as they may not be stable or sterile.”

Recognizing and Responding to Eye Infections

Given the potential risks associated with contaminated eye drops, it’s crucial to be able to recognize the signs of an eye infection. Common symptoms include:

  • Redness and swelling of the eye or eyelid
  • Increased tear production or discharge
  • Pain or a feeling of pressure in the eye
  • Blurred or decreased vision
  • Sensitivity to light
  • A gritty sensation in the eye

Should you experience any of these symptoms, especially after using eye drops, seek immediate medical attention. Early diagnosis and treatment are crucial in preventing serious complications, including vision loss.

The Role of Preservatives in Eye Drops

Many eye drops contain preservatives to prevent bacterial growth and extend shelf life. However, these preservatives can sometimes cause irritation, especially in people with sensitive eyes or those who use drops frequently.

Preservative-free options are available and may be a better choice for some patients. These typically come in single-use vials, which reduce the risk of contamination. However, they must be used immediately after opening and cannot be stored for future use.

When choosing between preserved and preservative-free eye drops, consider the following factors:

  • Frequency of use: If you need to use drops more than 4-6 times per day, preservative-free options may be less irritating.
  • Eye sensitivity: Those with sensitive eyes or certain eye conditions may tolerate preservative-free drops better.
  • Cost: Preservative-free drops are often more expensive than their preserved counterparts.
  • Convenience: Preserved drops in multi-dose bottles may be more convenient for some users.

Consult with your eye care professional to determine the best option for your specific needs.

Emerging Technologies in Eye Drop Delivery

As concerns about eye drop safety continue to grow, researchers and pharmaceutical companies are exploring new technologies to improve the delivery and safety of these essential medications. Some promising developments include:

Nanoparticle Formulations

Nanoparticle-based eye drops may offer improved drug delivery and retention on the eye surface. This could lead to more effective treatments with fewer applications, reducing the risk of contamination from frequent use.

Smart Delivery Systems

Innovative delivery systems, such as electronic eye drop dispensers, are being developed to ensure precise dosing and reduce the risk of contamination from mishandling.

Extended-Release Formulations

Researchers are working on eye drops that can provide sustained release of medication over time, potentially reducing the frequency of application and the associated risks of contamination.

Preservative Alternatives

New preservative technologies are being explored that may offer the benefits of preventing bacterial growth without the irritation associated with traditional preservatives.

While these technologies are still in development, they offer hope for safer and more effective eye drop treatments in the future.

The Importance of Regular Eye Exams

Regular eye exams play a crucial role in maintaining overall eye health and can help detect potential issues early, including those that may be related to eye drop use. During these exams, eye care professionals can:

  • Assess the effectiveness of current eye drop treatments
  • Identify any adverse reactions or complications
  • Recommend alternative treatments if necessary
  • Screen for other eye conditions that may require attention

The frequency of eye exams may vary depending on factors such as age, overall health, and existing eye conditions. However, most adults should have a comprehensive eye exam at least every two years, while those with chronic conditions or using eye medications may need more frequent check-ups.

Natural Remedies and Lifestyle Changes for Dry Eye Relief

While artificial tears are a primary treatment for dry eye disease, there are several natural remedies and lifestyle changes that can complement medical treatments and provide additional relief:

Omega-3 Fatty Acids

Consuming foods rich in omega-3 fatty acids, such as fatty fish, flaxseeds, and walnuts, or taking supplements may help improve tear production and quality.

Hydration

Staying well-hydrated by drinking plenty of water throughout the day can help maintain moisture levels in the body, including the eyes.

Humidifiers

Using a humidifier in dry environments, particularly while sleeping, can help prevent moisture evaporation from the eyes.

Screen Breaks

Following the 20-20-20 rule (taking a 20-second break to look at something 20 feet away every 20 minutes) can help reduce eye strain and dryness associated with prolonged screen use.

Protective Eyewear

Wearing wraparound sunglasses or other protective eyewear in windy or dry conditions can help prevent moisture loss from the eyes.

Warm Compresses

Applying warm compresses to the eyes can help stimulate tear production and relieve symptoms of dry eye.

While these natural remedies can be helpful, it’s important to consult with an eye care professional before making significant changes to your eye care routine, especially if you have an existing eye condition.

The Future of Eye Drop Safety and Regulation

The recent recalls of various eye drop brands have sparked discussions about the need for stricter regulations and improved safety measures in the production and distribution of these products. As a result, we may see several changes in the coming years:

Enhanced Quality Control

Manufacturers may implement more rigorous quality control processes to ensure the sterility and safety of their products throughout the production and packaging stages.

Improved Packaging Design

New packaging designs may be developed to reduce the risk of contamination during use and storage, such as single-use vials or bottles with advanced antimicrobial properties.

Increased FDA Oversight

The FDA may implement more frequent inspections and stricter guidelines for eye drop manufacturers to ensure compliance with safety standards.

Consumer Education Initiatives

There may be a push for more comprehensive consumer education about the proper use, storage, and potential risks associated with eye drops.

Advanced Testing Methods

New technologies for detecting contaminants and ensuring product sterility may be developed and implemented in the manufacturing process.

These potential changes aim to enhance the safety and efficacy of eye drops, providing consumers with greater peace of mind when using these essential products.

As the eye care industry continues to evolve, staying informed about product recalls, safety guidelines, and emerging treatments is crucial for maintaining optimal eye health. By working closely with eye care professionals and following best practices for eye drop use, patients can minimize risks and maximize the benefits of these important medications.

FDA recalls 3 brands of eye drops. What patients need to know

Eye Health and Vision ScienceMarch 14, 2023

By Lisa Howard(SACRAMENTO)

The Food and Drug Administration (FDA) has recently recalled three brands of eye drops, including one that has been linked to serious infections, vision loss and a death. UC Davis Health experts share what you need to know.

Consumers are advised to stop using the following brands and return them to the place of purchase.

EzriCare Artificial Tears Lubricant Eye Drops has been associated with severe eye infections and should be discarded.

  • Artificial Tears Lubricant Eye Drops distributed by EzriCare, LLC and DELSAM Pharma. On Feb. 2, the FDA issued a warning not to use EzriCare Artificial Tears because of potential bacterial contamination. The over-the-counter product was associated with severe eye infections in 55 patients, including one death. The infections were caused by a drug-resistant bacteria, Pseudomonas aeruginosa.
  • Brimonidine Tartrate Ophthalmic Solution, 0.15%. Apotex Corp. initiated a voluntary recall for six lots of Brimonidine Tartrate Ophthalmic Solution on March 1 due to cracks in the caps. The prescription drops are used for patients with open-angle glaucoma or ocular hypertension. No infections have been associated with the product. 
  • Purely Soothing 15% MSM Drops. The FDA announced on March 3 that Pharmedica USA was voluntarily recalling two lots of Purely Soothing Drops. This over-the-counter product is being recalled due to non-sterility. There have not been reports of illness or infection related to the product.

In addition to drops, the FDA has also recalled Global Pharma Healthcare Artificial Eye Ointment due to possible bacterial contamination. No infections have been associated with this over-the-counter product.

“If you are using any of these specific products, stop,” said Gary D. Novack, a professor at UC Davis Health. Novack is a clinical pharmacologist with decades of experience in ophthalmic product development.

The UC Davis Eye Center has not seen any cases linked to the EzriCare drops, but infections have been reported in 12 states, including California.

“Using contaminated artificial tears increases the risk of eye infections that could result in blindness or serious illness,” Novack said.

Common symptoms of an eye infection include blurry vision, discharge, pain or discomfort, redness of the eyelid or eye, feeling like there is something in the eye, and increased sensitivity to light. “If you have any of these symptoms, please see an eye care professional,” Novack said. 

Artificial tears, like those in the recalled EzriCare drops, are the mainstay treatment for dry eye disease, according to Jeffrey H. Ma, an ophthalmologist at the UC Davis Eye Center. Ma specializes in ocular surface diseases — diseases that damage the surface layers of the eye.

“Dry eye disease is one of the most common eye diseases and can cause irritation, grittiness, redness, burning, tearing and blurred vision. Artificial tears can help with these symptoms,” Ma explained.

He notes that patients should pay attention to recalls like those announced by the FDA, but they don’t need to stop using all eye drops, which are safe when used correctly.

“Preservative-free drops come in disposable single-use vials. So long as people do not touch the tip of the vial to their eyes or keep it for more than a day, preservative-free drops are safe and a great option for dry eyes,” Ma said. “They tend to be gentle on the eyes and can be used more frequently throughout the day.”

Other steps to prevent eye infections include making sure to wash your hands before touching your eyes or eye drops. It’s also important to check the expiration date. 

“Patients should not use eye-care products beyond the expiration date, as they may not be stable or sterile,” Ma explained.

The three recent eye-drop recalls appear to be unrelated. EzriCare Artificial Tears were recalled after the CDC linked them to serious infections in multiple states. The recall of Brimonidine Tartrate Ophthalmic Solution was initiated due to a manufacturing problem with the caps. Purely Soothing, 15% MSM Drops were recalled due to non-sterility.

For more information about drug recalls, visit the FDA website. If you think you may have an eye infection, contact your eye care provider.

The UC Davis Eye Center
The UC Davis Eye Center provides world-class eye care, pioneers collaborative vision research, and trains the next generation of specialists and investigators to become leaders in the Sacramento region and beyond. The Eye Center team aims to transform vision care and develop cures for blinding eye diseases, from cornea to cortex.

Browse Topic: Eye Health and Vision Science | News

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How does dry eye syndrome affect daily life?

Why is it not possible to live and work normally?

What happens

We have already written about how tears are produced in normal conditions and in dry eye syndrome. Recall briefly:

OK For dry eye syndrome
A tear consists of many components: water, fats, mucous substances, natural antiseptics, enzymes, etc. All the “components” are in perfect balance. The ratio of “water-lipids-mucins” is disturbed in the direction of greater “wateriness” of the tear.
Tear film stable. Tear film breaks and dries quickly, renews more slowly due to infrequent blinking.
Tears are released as much as needed. Because of the “dry eye”, compensation mechanisms are activated, and tears become more. Tears literally “flow like a stream out of the blue”, then dryness and irritation occur.
The cornea is protected, hydrated, nourished and fully fulfills its role in clear vision. The cornea dries up, its protection is weakened, nutrition is disturbed, inflammation and defects occur, up to ulcers. Vision is fuzzy, blurry.

The causes of “dry eyes” are very diverse, from air conditioning in the office and computer, to hormonal disorders, diseases and drugs. What unites them is an excess of compounds dangerous for the cells of the lacrimal glands that damage them, the so-called free radicals. As a result, the cell dies, the tears become smaller. Normally, the body also has “protector” molecules that counteract this process. When the balance is disturbed, dry eye syndrome occurs.

Treat or go away on its own?

It is customary in our country to ignore the symptoms “to the last”. With “dry eyes” – this is not the best solution, and it will not be possible to forget about red, dry, irritated eyes. This will not go away on its own, and the condition will only progress, because the cells of the glands die further, there are less and less of them, and dryness is aggravated. Without treatment, it will only get worse, up to irreversible changes in the cornea and blindness.

What to do

First, don’t panic. Contact a competent ophthalmologist and undergo a diagnosis. It includes the Norn test, the Schirmer test, a questionnaire with an assessment of symptoms in points, a slit lamp examination for corneal moisture and the presence of defects on it. As a result, the doctor concludes whether there is a “dry eye” syndrome or is it something else, prescribes treatment or continues the examination.

We categorically do not recommend buying eye drops “for dry and red eyes” or using the advice of non-specialists from the Internet – you can seriously damage your eyesight.

Delfanto

® – a real help for “dry eye” syndrome

Previously, there was only one salvation from “dry eye” – artificial tear substitutes. They are very different: with or without preservatives, natural and not quite. A common feature and disadvantage of artificial tears is that over time they stop working. Life turns into an endless search for the cherished bottle with “ideal” drops, which will relieve painful symptoms.

Now there is an alternative – to restore the ability of the cells of the lacrimal glands to work normally again and moisturize the eyes naturally. Such a drug has already been registered in Russia under the trademark Delfanto ® and is a patented composition of MaquiBright ® , a plant extract of Aristotelia chile from South America. Produced by Delfanto ® in Germany according to GMP standards, under the trademark Xevakrin ® is actively used in Europe.

Delfanto

® allows you to:

  • Get rid of the symptoms of “dry eye” by acting on its cause – the production of tears. The active substances of Delfanto ® are antioxidants, the same “defenders” of cells from damage, and the effect of taking is visible already in the second week of taking.
  • Long-term normalization of tear production – according to the study, by the end of the second month of administration, the intensity and number of symptoms decreases by 4 times.
  • Stop depending on the drops and experience inconvenience – at the initial stage, they can be combined with taking Delfanto ® , and then gradually stop instilling drops and switch to taking capsules 1-2 times a day.

In addition, Delfanto ® is also suitable for the prevention of “dry eyes” when there are risk factors, for example, when working at a computer for a long time, using contact lenses, after laser vision correction, taking certain medications and other situations.

Don’t tempt fate. Protect yourself and those you care about.

what is it? Indications, action, choice of artificial tears and their analogues

Contents

What are artificial tears for?

Who should use artificial tears?

Composition of artificial tears

How artificial tears work

How often can artificial tears be used?

Precautions when using artificial tears

Gilan solution for dry eye syndrome

Artificial tears are aqueous solutions of moisturizing biologically inert or active polymers. In order to give the preparations the maximum resemblance to the natural lacrimal fluid, various natural and chemical additives are introduced into them.

These solutions are used to prevent and treat dry eye syndrome, a condition caused by changes in the amount and composition of natural tears.

What are artificial tears for?

“Artificial tears” preparations are used both to improve the osmolarity and acidity of natural tears, and as a full-fledged tear substitute, when the mechanism of tear film formation is impaired and it does not form naturally, clinical signs of corneal damage are observed.

The solution applied to the surface of the eyeball, due to its viscous consistency, is not absorbed, but spreads and is retained on the cornea. Thanks to this action, the reproduction of the optical properties of the tear film is achieved, the condition of the cornea is stabilized and improved.

Who should use artificial tears?

The range of applications for artificial tears is very wide. Moisturizing solutions are prescribed not only as a therapeutic, but also as a prophylactic and auxiliary agent, for example:

  • to prolong the action of other ophthalmic drugs;
  • to eliminate irritation caused by the action of other eye drops or external factors;
  • to relieve symptoms of fatigue when driving a car, working and playing at a computer.

Tear substitutes are indicated for patients with ophthalmic diseases:

  • dry eye syndrome;
  • keratopathy;
  • trophic ulcers and corneal erosion;
  • xerosis;
  • Sjögren’s disease;
  • Stevens-Johnson syndrome;
  • keratosis.

Also, such drugs are used during the rehabilitation period after keratoplasty, refractive correction surgery, cataract removal.

Composition of artificial tears

Tears are classified into 4 groups:

  • preparations with hyaluronic acid;
  • cellulose derivatives;
  • preparations based on carbomer or polyvinyl alcohol;
  • preparations with several moisturizing ingredients.

Solutions with hyaluronic acid and other moisturizing ingredients are characterized by fewer adverse reactions, while preparations with carboxymethylcellulose and hydroxypropylcellulose can cause redness of the eyes, photophobia, and general discomfort. In addition, hyaluronate increases tissue permeability, which contributes to the rapid onset of a therapeutic effect.

How artificial tears work

Artificial tears work as keratoprotectors. They envelop the surface of the cornea and protect it from external influences, while at the same time they contribute to the supply of nutrition to the tissues of the cornea.

The substances that make up the keratoprotector prosthetics (replace) the insufficient layer of the tear film, provide long-term hydration, stimulate cell regeneration, and have an anti-inflammatory effect.

Symptom reduction is observed, as a rule, on the 3rd-5th day, and pronounced improvements after 2-3 weeks. Depending on the severity of the disease, a tear substitute can be used for a longer period.

How often can artificial tears be used?

Artificial tears are biocompatible, so they do not cause serious side effects. Cases of an allergic reaction are extremely rare. The drug is instilled into the conjunctival sac, 1-2 drops. The frequency of instillation is from 4 to 8 times a day, but if necessary, you can use it every hour. Apply tear substitutes until the symptoms disappear.

Although these solutions are OTC, they should be selected by an ophthalmologist. Of great importance for the effectiveness of treatment is the viscosity of the solution, the presence of preservatives in it.

Precautions when using artificial tears

The first instillation of the solution may cause a burning sensation, blurred vision. If the drug is chosen incorrectly, then there is a risk of exacerbation of other pathologies. For those who wear contact optics, it is advisable to use solutions with hyaluronic acid, which provide good sliding of the lens on the surface of the eye and moisturizing the cornea.