FDA warns eye drops could cause serious vision-threatening infection
KANSAS (KSNT) - The FDA is warning consumers not to purchase two types of eye drops due to bacterial contaminations, fungal contaminations or both.
The FDA is advising consumers to discard Dr. Berne's Whole Health Products 'Light Eyez' distributed by LightEyez Limited. The product contains methylsulfonylmethane (MSM); an unapproved drug and illegally marketed in the U.S.
Product testing showed the products were contaminated with microbes and were not sterile. The FDA found the following bacterial contaminations:
- Dr. Berne's MSM Drops 5% Solution
- Bacillus
- LightEyez MSM Eye Drops - Eye Repair
- Pseudomonas
- Mycobacterium
- Mycolicibacterium
- Methylorumbrum
On Aug. 21, the FDA emailed LightEyez Limited to discuss further steps to protect consumers from the contaminated eye drops. Lighteyez has not responded to the FDA or taken action to protect consumers. Dr. Berne verbally agreed on Aug. 21 to recall the Dr. Berne's MSM Drops 5% Solution, according to the FDA.
Using the eye drops could result in a serious vision-threatening infection and could progress to a life-threatening infection, according to the FDA.
From May 2022 through April 2023, 14 patients experienced vision loss, 4 patients required surgical removal of their eyeball and four deaths were attributed to an outbreak from a drug-resistant strain of bacteria found in certain artificial eye ointments (EzriCare Artifical Tears, Delsam Pharma's Artificial Tears and Delsam Pharma's Artificial Ointment), according to the Centers for Disease Control and Prevention.
The FDA is unaware of any adverse reports associated with Dr. Berne's or LightEyez eye drop products as of Aug. 22. Patients with signs or symptoms of an eye infection should seek a health care professional or medical care immediately, according to the FDA.