FDA Announces Warnings on 2 More Eye Drops Products

FDA warns against using Dr. Berne’s MSM Drops 5% Solution and LightEyez MSM Eye Drops—Eye Repair due to bacterial and fungal contamination. These products are distributed by Dr. Berne’s Whole Health Products and LightEyez Limited, respectively. While the FDA has not received any reports of adverse events linked to the use of either product, these eye drops should be appropriately discarded according to FDA suggestions. Patients displaying signs or symptoms of an eye infection are urged to speak with their health care provider or promptly seek medical attention.

Using tainted medications of any kind can be dangerous. “Using contaminated eye drops could result in minor to serious vision-threatening infection which could possibly progress to a life-threatening infection,” according to the announcement.

In addition to the lack of sterility, the eye drop products from Dr. Berne and LightEyez contain the unapproved active ingredient, methylsulfonylmethane (MSM). No ophthalmic drugs containing MSM as an active ingredient are marketed legally in the US at this time.

FDA found the problem while conducting testing on eye drops due to recent manufacturing issues. The products were found to be contaminated and not sterile. Eye drops must be sterile to be safe, according to the Federal Food, Drug and Cosmetic Act. The table below shows specific microbes found in testing. Dr. Berne voluntarily recalled MSM Drops 5% Solution. FDA contacted LightEyez Limited on August 21, 2023, about their contaminated products but received no response. In addition, the company has also not “taken action to protect consumers from using the contaminated eye drops,” according to the FDA announcement.

Some of the contamination of the Dr. Berne’s MSM Drops 5% Solution were Bacillus, spp. and Exophiala, sp. The microbial contaminants in LightEyes MSM Eye Drops–Eye Repair were Pseudomonas, spp.; Mycobacterium, spp.; Mycolicibacterium, spp.; and Methylorubrum, spp.

This FDA’s recommendation brings to mind the CDC statement urging the immediate discontinuation of the use of EzriCare Artificial Tears in January 2023.

The CDC linked those EzriCare Artificial Tears eye drops to a “multistate cluster of Verona Integron‐mediated Metallo‐β‐lactamase (VIM)‐ and Guiana‐Extended Spectrum‐β‐Lactamase (GES) producing carbapenem‐resistant Pseudomonas aeruginosa (VIM‐GES‐CRPA) associated with multiple different types of infections, including eye infections” as noted in an Infection Control Today article. In addition to demonstrating carbapenem resistance, isolates in this cluster have shown resistance to ceftazidime and cefepime. The CDC reported 10 patient cases of the EzriCare Artificial Tears had eye involvement with one case of permanent vision loss. There has also been one death reported.