At least three people have died, eight people have permanently lost vision, and four people had to have an eye removed because of bacterial infections associated with preservative-free eye drops, the CDC said in its most recent summary.
After more than 50 reported cases of extensively antibiotic-resistant infections, the international company Global Pharma Healthcare issued a voluntary recall of all lots of Artificial Tears Lubricant Eye Drops because of possible contamination, according to the U.S. Food and Drug Administration (FDA). The artificial tears were distributed by two companies, EzriCare and Delsam Pharma. On February 22, 2023, the FDA recommended that Global Pharma add all lots of Delsam Pharma’s Artificial Eye Ointment to its recall, also because of potential bacterial contamination.
The FDA and CDC both recommend clinicians and patients stop using these products because they could result in infection that leads to permanent blindness.
As of March 14, CDC investigators had located at least 68 people in 16 states infected with Pseudomonas aeruginosa, a type of bacteria that is resistant to treatment with antibiotics. Nearly 40 of those cases were linked to four clusters of infections in healthcare facilities.
So far, the CDC has identified cases in California, Colorado, Connecticut, Florida, Illinois, North Carolina, New Jersey, New Mexico, New York, Nevada, Pennsylvania, South Dakota, Texas, Utah, Washington state, and Wisconsin.
New Mexico public health officials said in a January 10 statement that 11 patients who tested positive for P. aeruginosa each had underlying eye diseases and used medicated eye drops or artificial tears prior to their infection. So far, five of these patients have developed vision loss in an eye treated with drops.
The multistate investigation is ongoing. Most affected patients reported using artificial tears, with EzriCare being the most commonly reported brand used. Laboratory testing by the CDC identified P. aeruginosa in opened EzriCare bottles collected from patients. The agency is still in the process of testing unopened bottles to determine whether the contamination may have occurred during manufacturing.
Affected Bottles of Artificial Tears and Artificial Eye Ointment Should Be Discarded
“CDC recommends that clinicians and patients immediately discontinue the use of EzriCare Artificial Tears until the epidemiological investigation and laboratory analyses are complete,” the CDC said.
EzriCare announced in a January 24 statement that the company had not received any consumer complaints, reports of adverse events, or communication from regulators about the ongoing investigation into infections linked to its eye drops.
The company also said it doesn’t manufacture the product under investigation. The EzriCare Artificial Tears were formulated, designed, and imported by Aru Pharma in the United States and were manufactured by Global Pharma Healthcare PVT in India, EzriCare Ltd. said.
“Nevertheless, and in an abundance of caution, EzriCare recommends that during this evolving situation you discontinue use of any portions of EzriCare Artificial Tears Lubricant Eye Drops you may have until we can discover more details about any potential safety concerns,” EzriCare said. Consumers can contact the company at@ezricare-info.com with any questions or concerns.
What Is the Bacteria Behind These Eye Infections?
P. aeruginosa can cause many types of infections, including pneumonia, bloodstream infections, urinary tract infections, and surgical site infections, according to the CDC. It is one of a growing number of organisms that are resistant to treatment with many commonly prescribed antibiotics.
There have been some previous reports of eye infections from P. aeruginosa, including some cases related to mascara applicators and improper use or care of contact lenses, according to the CDC.
Over-the-counter eye drops may be used to relieve a variety of conditions, including dryness, itchiness, and redness. Artificial tears are lubricating eye drops often used to relieve dry eye, according to the Mayo Clinic.
