The American Optometric Association (AOA) has issued a consumer alert urging individuals to consult their local optometrists before using or purchasing over-the-counter (OTC) eye drops, particularly MSM eye drops that claim to change eye color. This alert comes in the wake of ongoing concerns following an FDA-issued warning regarding potential contamination in certain MSM eye drops, which has led to discussions about an eye drops recall.
In August 2023, the U.S. Food and Drug Administration (FDA) warned consumers against using Dr. Berne’s MSM Drops 55 Solution and LightEyez MSM Eye Drops – Eye Repair due to bacterial and fungal contamination. These eye drops, marketed with claims of eye color change and lightening, pose serious health risks, including vision-threatening infections, according to the FDA. Despite these concerns, as of February 2024, the manufacturer, LightEyez Limited, had not initiated a formal recall of these products through the FDA, raising alarm among health authorities.
The AOA emphasizes that there are currently no FDA-approved eye drops on the market that safely alter eye color. In its consumer alert, the AOA advises individuals to discuss any medications, including OTC eye drops, with their optometrist before use. “Talking with a doctor of optometry ensures that the correct treatment plan is in place and helps prevent potential risks,” the AOA stated.
The FDA’s warning letter highlights the risks of contamination from microorganisms such as Pseudomonas spp., Mycobacterium spp., and Methylorubrum spp. in the LightEyez products. These microbial contaminants can cause infections that range from minor to severe, including life-threatening complications. Due to the method of administration, which bypasses many of the body’s natural defenses, contaminated eye drops pose a significant risk to ocular health.
In response to these concerns, the FDA conducted an on-site investigation of LightEyez Limited’s manufacturing facilities in September 2023. However, the company was not found at the investigated location, adding to the urgency for a formal eye drops recall.
The AOA’s alert serves as a reminder that professional guidance is critical when using any eye care products. Consumers should be aware of the risks associated with contaminated eye drops, particularly products making unsupported claims like eye color change.
References
- Consumer alert: eye color changing eye drops. News release. American Optometric Association. August 12, 2024. Accessed August 20, 2024.
- Warning Letter. LightEyez Limited. US FDA. MARCS-CMS 665450. February 27, 2024. Accessed August 20, 2024.
- FDA warns consumers not to purchase or use certain methylsulfonylmethane (MSM) eye drops due to contamination. FDA. News release. August 22, 2023. Accessed August 20, 2024.