Pseudomonas aeruginosa-contaminated eye drops have been front and center in health news headlines across the country recently as the US Food and Drug Administration has announced multiple product recalls and the Centers for Disease Control and Prevention (CDC) reports more than 50 infections, including a few that resulted in deaths.
Currently, the CDC and the FDA are partnering with state and local health departments to assess the situation, with the outbreak strain identified as carbapenem-resistant Pseudomonas aeruginosa with Verona integron-mediated metallo-β-lactamase and Guiana extended-spectrum-β-lactamase (VIM-GES-CRPA). This strain has never before been reported in the US.1
While the threat remains rare, the outcomes for those infected can be severe. Optometrists as primary eye care physicians are on the front lines in the fight to protect patients and preserve ocular health. By identifying the cause, staying apprised of developments, and applying the tool of their education, every OD in the country can prepare to face this challenge.
Complications to Date
Although the story continues to evolve, as of March 21, 2023, the CDC, along with state and local health departments, has identified 68 patients in 16 states as being infected with VIM-GES-CRPA. In total, 37 patients were tied to 4 healthcare facility clusters, with 8 reports of vision loss, 4 cases of enucleation, and 3 deaths.1
Most patients reported that they used artificial tears — with more than 10 different brands implicated; some patients noted using multiple brands. Nevertheless, EzriCare Artificial Tears (Global Pharma Healthcare), which is preservative-free, was most commonly reported and the common culprit identified in the 4 healthcare-facility clusters. Lab testing by the CDC confirmed the presence of VIM-GES-CRPA in opened EzriCare bottles representing multiple lots. Currently, unopened bottles are being tested for the strain to assess whether contamination may have occurred during manufacturing.1
“Over-the-counter drops have a very good track record of safety,” said A. Mika Moy, OD, Associate Dean for Admissions and Student Affairs at the UC Berkeley School of Optometry. “I have been practicing for 25 years and this is the first time that artificial tears have been recalled to my knowledge.”
Additional contaminated eye drop-related recalls include Delsam Pharma Artificial Eye Ointment (Global Pharma Healthcare), Apotex Brimonidine Tartrate Ophthalmic Solution 0.15% (Apotex Corp.), and Pharmedica Purely Soothing, 15% MSM Drops (Pharmedica USA).2-4
The Threat of Pseudomonas aeruginosa
Pseudomonas aeruginosa results in a glut of infections, including those affecting the lung, skin, and cornea like microbial keratitis. Multidrug resistant (MDR) P. aeruginosa is becoming increasingly prevalent — although Pseudomonas-contaminated eye drops are still rare — and MDR management is challenging. Antibiotic resistance usually occurs secondary to chromosomal gene mutations and the possession of transferrable resistance determinants. MDR isolates may be clonal—especially in the case of hospital-acquired infections—with clones from different environments heterogenous in nature.5
Clones can cause infection outbreaks when they transition to a new environment. For instance, P. aeruginosa from water sources can infect the lungs of those with cystic fibrosis. To date, clones of ocular isolates have been rarely reported.5
“Pseudomonas is a particularly virulent bacteria that can attack the eye and do damage in a quicker time frame than other bacteria,” said Dr Moy. “I would not say that this threat is increasing; however, as bacteria evolve, they always will develop resistance to antibiotics — some more rapidly than others.”
She added, “This is a very unusual case, where infections seem to be coming from contaminated bottles of artificial tears.”
Despite the daunting nature of recent reports, in an exclusive interview, American Optometric Association (AOA) president Ronald L. Benner, OD, allayed fears.
“Pseudomonas aeruginosa is a rare strain and in this case, the product was recalled for manufacturing violations. When manufactured properly and used as directed, eye drops are safe. Therefore, there’s no reason to believe the threat is increasing,” Dr Benner said.“Many doctors of optometry were unfamiliar with these brands and had not recommended the product. With this report, all eye care providers are on high alert to inform patients and provide assistance or treatment when needed.”
To be sure, P. aeruginosa infections typically occur under different circumstances from contaminated eye drops.
According to Laine S. Higa, OD, an assistant professor at The Eye Institute of the Pennsylvania College of Optometry at Salus University, “Pseudomonas aeruginosa is a common culprit of corneal infections; typically observed in those who overwear and/or sleep in their contact lenses.”
He further clarified the current health hazard, “The concern over Pseudomonas aeruginosa and the recalled eye drops is that this is a resistant strain (to antibiotics). Overuse by the clinicians and noncompliance with antibiotics regimen by the patient may have resulted in this resistant strain. To curb the risk of future drug-resistant strains, clinicians should be cognizant of their antibiotic options and should not always go to the ‘strongest and best’ for mild infections.”
What Optometrists Can Do
Currently, the CDC and FDA are recommending that clinicians and patients cease utilizing any suspected Pseudomonas-contaminated eye drops — including EzriCare or Delsam Pharma’s Artificial Tears products pending further guidance. Moreover, clinicians are advised to report any carbapenem-resistant Pseudomonas aeruginosa (CRPA) from an ocular specimen or VIM-CRPA from any specimen source with collection dates dating back to January 1, 2022. Cases can be reported to the healthcare-associated infections contact at their local or state health departments, or clinicians can email the CDC for assistance at [email protected].1
It’s imperative that optometrists apprise their patients of the risk of infection. “Clinicians should alert their patients about the recalled eye drops. This could be done via patient portal notifications, emails, website postings and verifying that the patient is not taking a recalled eye drop during their visit,” said Dr Higa.
“Clinicians should advise patients who have used the recalled eye drops to stop the eye drop immediately and come in for an evaluation that they do not have early signs of an eye infection. Patients should be educated to bring in the bottle of eye drops as this may be needed to be sent in to the health department for testing,” he added.
Dr Benner concurred that a comprehensive eye examination is imperative in patients possibly exposed to the contaminated eye drops.
“Doctors of optometry should perform a comprehensive eye exam and based on each patient’s signs and symptoms, along with the doctor of optometry’s professional judgment, will determine what tests need to be conducted,” he said.
Clinicians should advise their patients on how to best use eye drops,
“Patients should be aware if they are sensitive to specific preservatives, to ensure the tip of the dropper does not touch their eye, to wash hands prior to instillation, to check the expiration date, and to dispose of preservative-free vials after use. Patients should use caution with any drops purchased over the internet from unregulated sources,” said Kamila Mikos, OD, of the State University of New York College of Optometry.
On a final note, patients themselves also play a role in identifying their possible exposure.
“If a patient is concerned that they recently used these drops, they should be alert for any symptoms of eye infection including: redness, irritation or pain, excessive tearing, mucous discharge, or decrease in vision. They should discontinue using the drops immediately. If they have any concerns, they can visit their optometrist for an evaluation,” said Dr Moy.
- Outbreak of Extensively Drug-resistant Pseudomonas aeruginosa Associated with Artificial Tears. Centers for Disease Control and Prevention. https://www.cdc.gov/hai/outbreaks/crpa-artificial-tears.html. Updated March 21, 2023. Accessed March 29, 2023.
- Global Pharma Healthcare Issues Voluntary Nationwide Recall of Delsam Pharma Artificial Eye Ointment Due to Possible Microbial Contamination. US Food and Drugs Administration. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/global-pharma-healthcare-issues-voluntary-nationwide-recall-delsam-pharma-artificial-eye-ointment. Updated February 24, 2023. Accessed March 30, 2023.
- Apotex Corp. Issues Voluntary Nationwide Recall of Brimonidine Tartrate Ophthalmic Solution, 0.15% Due to Cracks that Have Developed in Some of the Units Caps of the Bottles. US Food and Drugs Administration. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/apotex-corp-issues-voluntary-nationwide-recall-brimonidine-tartrate-ophthalmic-solution-015-due. Updated March 1, 2023. Accessed March 30, 2023.
- Pharmedica USA LLC Issues Voluntary Worldwide Recall of Purely Soothing 15% MSM Drops Due to Non-Sterility. US Food and Drugs Administration. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/pharmedica-usa-llc-issues-voluntary-worldwide-recall-purely-soothing-15-msm-drops-due-non-sterility. Updated March 3, 2023. Accessed March 30, 2023.
- Khan M, Willcox MDP, Rice SA, Sharma S, Stapleton F. Development of antibiotic resistance in the ocular Pseudomonas aeruginosa clone ST308 over twenty years. Exp Eye Res. 2021;205:108504. doi:10.1016/j.exer.2021.108504.