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Important Information for Artificial Tears Users

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Important information: Stop using either EzriCare or Delsam Pharma’s Artificial Tears immediately.

The Centers for Disease Control and Prevention (CDC) is working in conjunction with the Food and Drug Administration (FDA) and local and state health departments to investigate an outbreak of Pseudomonas aeruginosa, which is an extensively drug-resistant strain of infection. This particular outbreak is affecting multiple states and is associated with various types of infections, including those of the eyes. The strain responsible for this outbreak, carbapenem-resistant Pseudomonas aeruginosa with Verona integron-mediated metallo-beta-lactamase and Guiana extended-spectrum-beta-lactamase (VIM-GES-CRPA), has not been documented in the United States prior to this event. The investigation has revealed that many patients were exposed to the strain through artificial tears.

There are four healthcare facility clusters where 37 patients have been linked. During the outbreak, three individuals have died, and there have been eight cases of vision loss and four cases of enucleation (removal of the eyeball) reported. The specimen collection dates range from May 2022 to February 2023, with isolates being identified from a variety of clinical cultures from various body parts.

The majority of patients reported using artificial tears, with over 10 different brands being mentioned, and some patients using multiple brands. The most commonly reported brand was EzriCare Artificial Tears, an over-the-counter, preservative-free product packaged in multidose bottles. This was the only artificial tears product identified in all four healthcare facility clusters. Laboratory testing by the CDC discovered the presence of VIM-GES-CRPA in opened EzriCare bottles from several lots, collected from patients with and without eye infections, and from two different states. The VIM-GES-CRPA in opened products matched the outbreak strain. Testing of unopened bottles of EzriCare Artificial Tears is ongoing to assist in evaluating whether contamination may have occurred during manufacturing. For now, patients and healthcare providers are advised to immediately stop using EzriCare or Delsam Pharma’s Artificial Tears until further information and guidance from the CDC and FDA become available.

If your healthcare provider has previously advised the use of these products, please contact them for suggestions on alternative treatment options.

Individuals who have used either of these artificial tears products and exhibit the following signs or symptoms of an eye infection, should immediately seek medical attention.

  • 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

There is currently no recommendation for testing patients who have used the product and do not have any indications or symptoms of infection.

To read more and stay up to date, click https://www.cdc.gov/hai/outbreaks/crpa-artificial-tears.html