The FDA on Aug. 22 issued a consumer warning on two eye drop products contaminated with bacteria, fungus or both.
Consumers should not purchase and should stop using Dr. Berne's MSM 5 percent solution and LightEyez MSM products because sampling and testing conducted by the FDA found they were contaminated with several microbes and were not sterile, the warning said.
"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, adding that it is not currently aware of anyone reporting adverse events from using the products.
Additionally, both products are unapproved and illegally marketed in the U.S. as they contain methylsulfonylmethane, or MSM, as an active ingredient, which the FDA said is not approved in any eye drop products in the U.S. According to the FDA, Dr. Berne verbally agreed to recall its product on Aug. 21, though LightEyez had not responded to the FDA "or taken action to protect consumers" as of Aug. 22 when the warning was posted.
The latest warnings come after a drug-resistant bacteria outbreak earlier this year tied to several other contaminated eye drop brands. Eighty-one people in 18 states were identified with Pseudomonas aeruginosa as of May 15; four died, according to the CDC. Those affected had used several different eye drops, though EzriCare Artificial Tears was the most commonly reported exposure.