Eye drops contaminated with a drug-resistant bacteria may have caused death, blindness and eyeball removals in the US, according to officials.
Some 68 patients in 16 states, spanning from New York and Washington to Texas and Florida, have been identified with a rare strain of pseudomonas aeruginosa by the Centers for Disease Control and Prevention (CDC).
Prior to the current outbreak, it had never been reported in the US before.
While one person has died, there have been eight reports of vision loss and four of people having their eyes surgically removed, said the CDC.
Most patients infected reported using artificial tears.
Of more than 10 brands initially identified, the most common was the over-the-counter product EzriCare.
Laboratory testing of open bottles taken from patients were found to contain the bacteria.
Unopened bottles are currently being examined to check whether contamination occurred during manufacturing.
India-based Global Pharma Healthcare, which makes EzriCare and Delsam Pharma artificial tears, issued a product recall last month after the CDC urged people to immediately stop using the eye drops.
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A number of patients have already launched legal action, including a Florida woman who alleges she lost an eye after using the now-recalled eye drops.
Her lawyer Natasha Cortes told NBC News: "It doesn't contain preservatives, which are used to fight bacterial contamination of these products.
"There's likely many more people who have suffered infections who are unaware."
Patients who have used the products and have symptoms of an eye infection are advised to seek urgent medical advice.
Signs include yellow, green, or clear discharge from the eye, discomfort or pain, redness, blurry vision and increased sensitivity to light.