Safety Report: Extensively Drug-resistant Pseudomonas aeruginosa Outbreak linked to Artificial Tears, USA

United States

Update March 21, 2023

As of March 14, 2023, CDC, in partnership with state and local health departments, identified 68 patients in 16 states (CA, CO, CT, FL, IL, NC, NJ, NM, NY, NV, PA, SD, TX, UT, WA, WI) with VIM-GES-CRPA, a rare strain of extensively drug-resistant P. aeruginosa. 37 patients were linked to four healthcare facility clusters. 3 people have died and there have been 8 reports of vision loss and 4 reports of enucleation (surgical removal of eyeball). Dates of specimen collection were from May 2022 to February 2023. Isolates have been identified from clinical cultures of sputum or bronchial wash (15), cornea (17), urine (10), other nonsterile sources (4), and blood (2), and from rectal swabs (26) collected for surveillance; some patients had specimens collected from more than one anatomic site.

The investigation is ongoing.

Source: CDC

February 07, 2023

The CDC is collaborating with the FDA and state and local health departments to investigate a multistate outbreak of an extensively drug-resistant strain of Pseudomonas aeruginosa which has identified artificial tears as a common exposure for many patients. The outbreak strain, carbapenem-resistant Pseudomonas aeruginosa with Verona integron-mediated metallo-β-lactamase and Guiana extended-spectrum-β-lactamase (VIM-GES-CRPA), had never been reported in the United States prior to this outbreak.

As of January 31, 2023, CDC, in partnership with state and local health departments, identified 55 patients in 12 states (CA, CO, CT, FL, NJ, NM, NY, NV, TX, UT, WA, WI) with VIM-GES-CRPA, a rare strain of extensively drug-resistant P. aeruginosa. 35 patients were linked to 4 healthcare facility clusters. 1 person has died and there have been 5 reports of vision loss. Dates of specimen collection were from May 2022 to January 2023. Isolates have been identified from clinical cultures of sputum or bronchial wash (13), cornea (11), urine (7), other nonsterile sources (4), and blood (2), and from rectal swabs (25) collected for surveillance; some patients had specimens collected from more than one anatomic site.

Patients reported over 10 different brands of artificial tears and some patients used multiple brands. EzriCare Artificial Tears, a preservative-free, over-the-counter product packaged in multidose bottles, was the brand most commonly reported. This was the only common artificial tears product identified across the four healthcare facility clusters. Laboratory testing by CDC identified the presence of VIM-GES-CRPA in opened EzriCare bottles from multiple lots. CDC and FDA recommend clinicians and patients stop using EzriCare or Delsam Pharma’s Artificial Tears products pending additional guidance from CDC and FDA.

At this time, there is no recommendation for testing of patients who have used this product and who are not experiencing any signs or symptoms of infection.

Eye infection symptoms may include:
- Yellow, green, or clear discharge from the eye
- Eye pain or discomfort
- Redness of the eye or eyelid
- Feeling of something in your eye (foreign body sensation)
- Increased sensitivity to light
- Blurry vision

In case you experience harm after using these products, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Source: www.cdc.gov/hai/outbreaks/crpa-artificial-tears.html