US health officials say that eyedrops may have killed one person and severely injured several others due to drug-resistant bacterial contamination.
The Centers for Disease Control and Prevention (CDC) have identified 68 patients across 16 states with a rare strain of Pseudomonas aeruginosa.
The strain had never been found in the US before this latest outbreak.
In addition to the one death, eight patients have suffered vision loss, and four have had eyes surgically removed.
Most of the patients diagnosed with the infection reported using eyedrops and artificial tears, according to the CDC.
Ten different brands were initially identified as possibly linked to the outbreak, the CDC said. Eyedrops that are made in India and imported to the US under two brands were subsequently pulled from shelves in January and February.
In January, the CDC warned people to stop using EzriCare Artificial Tears and Delsam Pharma’s Artificial Tears. The next month, the company that owns the brands – Global Pharma – issued a voluntary recall following a formal recommendation from the Food and Drug Administration (FDA).
Opened bottles taken from patients were found through testing to contain the bacteria, the CDC said. Unopened bottles are currently being tested to determine whether contamination occurred during the manufacturing process.
Last week, a woman in Florida sued the drug company, claiming that an infection she suffered after using their product forced doctors to remove one of her eyes.
A lawyer for the woman blamed the contamination on a lack of preservatives in the eyedrops.
“There’s likely many more people who have suffered infections who are unaware,” lawyer Natasha Cortes told NBC News.
A representative for EzriCare has said that testing so far has not definitively linked the outbreak to their products.
“To the greatest extent possible, we have been contacting customers to advise them against continued use of the product,” a spokesperson said.
“We also immediately reached out to both CDC and FDA and indicated our willingness to cooperate with any requests they have of us.”
The CDC said that anyone who has used the recalled products and are now experiencing symptoms should contact a doctor.
Symptoms include yellow, green, or clear discharge from the eye, discomfort or pain, redness, blurry vision and increase sensitivity to light.
Last week, the FDA published separate recall notices for some eyedrop products distributed by Pharmedica and Apotex after the companies said they voluntarily pulled them from shelves.
Eyedrops and eyewash products were used by approximately 117 million Americans in 2020, according to Statista, a market research firm.
