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What's the Problem with Dr. Berne's Eye Drops?
According to an FDA Press Release [1.] issued on August 22, 2023, scientists from the agency conducted testing based on the eye drops' intended use which showed them to be not sterile and contaminated with microbes. Under the Federal Food, Drug, and Cosmetic Act, eye drops must be sterile to be safe for use.
"Using contaminated eye drops could result in minor to serious vision-threatening infection which could possibly progress to a life-threatening infection," the FDA said.
Additionally, Dr. Berne's Eye Drops contain methylsulfonylmethane (MSM) as an active ingredient, which makes the products unapproved drugs that are illegally marketed in the United States. There are no legally marketed ophthalmic drugs that contain MSM as an active ingredient.
Which Products are Affected?
| Product | Bacterial contamination | Fungal contamination |
|---|---|---|
| Dr. Berne’s MSM Drops 5% Solution | Bacillus, spp. | Exophiala, sp. |
| LightEyez MSM Eye Drops – Eye Repair | Pseudomonas, spp.; Mycobacterium, spp.; Mycolicibacterium, spp.; Methylorubrum, spp. |
N/A |
Is There a Recall on Dr. Berne's MSM Eye Drops?
Yes. On August 21, 2023, Dr. Berne verbally agreed to voluntary recall the Dr. Berne’s MSM Drops 5% Solution. To date, the FDA is not aware of any adverse event reports associated with use of either Dr. Berne's MSM Eye Drops or LightEyez MSM Eye Drops.
4 Deaths, Dozens of Cases of Vision Loss Linked to Contaminated Eye Drops: CDC Warning
The U.S. Centers for Disease Control and Prevention (CDC) [4.] announced on May 15, 2023, that at least 4 deaths, 14 cases of vision loss, 4 cases of surgically removed eyeballs, and more than 80 infections of Pseudomonas aeruginosa have been reported in patients who used 10 brands of eye drops, most commonly EzriCare Artificial Tears.
On February 2, 2023, Global Pharma Healthcare announced a voluntary recall of its EzriCare artificial tears eyedrops [5.] in response to the Pseudomonas aeruginosa outbreak. The recall comes after the CDC warned consumers to immediately stop using eye drops.
Pseudomonas Aeruginosa Eye Infections
P. aeruginosa is a pathogenic, gram-negative bacterium that is resistant to treatment with antibiotics. The bacteria can cause swimmer’s ear -- a painful infection caused by tainted water that stays in the outer ear canal for too long -- and more severe conditions, particularly in individuals with compromised immune systems.
P. Aeruginosa Infection Symptoms
- Yellow, green, or clear discharge from the eye
- Eye pain or discomfort
- Redness of the eye or the feeling of something in your eye (foreign body sensation)
- Increased sensitivity to light
- Blurry vision
What is Methylsulfonylmethane?
Methylsulfonylmethane, or MSM, is a chemical that occurs naturally in humans, as well as some green plants and animals. It can also be made in a lab.
Although it is not known exactly what function MSM plays in the body, the substance is thought to supply sulfur to make other chemicals. However, there is no recommended dietary allowance (RDA) for MSM or sulfur, and sulfur deficiency is not a known condition.
People often use MSM to treat osteoarthritis. It is also commonly used for pain, swelling, aging skin, hay fever, and many other conditions, but there is no good scientific evidence to support most of these uses.
Tainted Eyedrops Linked to 3 Deaths, Extensive Vision Loss: NBC News Video
FDA Recommendation
The FDA is recommending that consumers properly discard Dr. Berne's MSM Eye Drops as described here [2.]. Patients who have any of the above symptoms of an eye infection should consult their doctor or other healthcare provider immediately. FDA encourages consumers and healthcare professionals to report adverse events associated with any medicine to the agency's MedWatch Adverse Event Reporting program [3.].
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Get a Free Dr. Berne's MSM Eye Drops Lawsuit Evaluation with Our Lawyers
The Product Liability Litigation Group at Schmidt & Clark, LLP law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Dr. Berne's MSM Eye Drops Lawsuits. We are handling individual litigation nationwide and currently accepting new legal challenges in all 50 states.
If you or a loved one suffered from permanent vision loss or other complications after using Dr. Berne's MSM Eye Drops, you should contact our law firm immediately for a free case evaluation. You may be entitled to financial compensation by filing a suit and we can help.
