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FDA Warns Consumers About Eye Drops and Issues a Recall

Jun 6, 2023 | Products Liability

eye drop use

Recently, the Food & Drug Administration (FDA) issued a recall for eye drops manufactured by EzriCare & Delsma Pharma.  The recall was issued due to the increased risk of contracting a drug-resistant bacteria. The recall states, “Using contaminated artificial tears increases risk of eye infections that could result in blindness or death. Patients who have signs or symptoms of an eye infection should talk to their health care provider or seek medical care immediately.”  You can read the full statement from the FDA here.

The following eye drops are currently being recalled as of May 2023:

  1. Artificial Tears Lubricant Eye Drops manufactured by EzriCare and Delsam Pharma brands. The product was recalled on February 2, 2023 after it was linked to the outbreak of the bacterial infection Pseudomonas aeruginosa, which is drug-resistant.
  2. Artificial Eye Ointment manufactured by Delsam Pharma. The product was recalled on February 23, 2023, over similar concerns from their Artificial Tears Lubricant Eye Drops.

The CDC’s latest report as of May 15, 2023, identified 81 patients in 18 states (CA, CO, CT, DE, FL, IL, NC, NJ, NM, NV, NY, OH, PA, SD, TX, UT, WA, WI) that contracted bacterial infections like pseudomonas aeruginosa from using eye drops. In addition, fourteen of those infected have been blinded and four have had their eyeballs surgically removed. The number of deaths linked to the outbreak has been reported at four, but the CDC expects the numbers to rise.

The Washington Post reported, “Pseudomonas aeruginosa is an aggressive bacterium that is found all over the environment, including in water, soil and human waste. It can enter eye drops through contamination with environmental agents during handling, experts say. The bacterium is resistant to most antibiotics and is particularly dangerous in health-care settings and for people with weakened immune systems.”

Patients who have used EzriCare or Delsam Pharma’s artificial tears or Delsam Pharma’s artificial eye ointment and who have signs or symptoms of an eye infection should seek medical care immediately.

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

If you or a loved one were injured due to an eye infection caused by an artificial tears product, please contact us for a free consultation with our experienced team.