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Eye drop recalls in 2023: What to know about the artificial tears recalls

Plus, what to do if you think you’ve used contaminated eye drops.

Eye drop recalls in 2023: What to know about the artificial tears recalls

Plus, what to do if you think you’ve used contaminated eye drops.

Well, we've got an eye opening recall to tell you about this morning. There are two eye drops you need to drop the FDA recalling. Doctor burns, eye drops and light eyes, MS M light eye drops. Now, they say those brands of eye drops can cause vision problems and potentially fatal eye infections.
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Eye drop recalls in 2023: What to know about the artificial tears recalls

Plus, what to do if you think you’ve used contaminated eye drops.

The list of eye drop recalls in 2023 keeps growing. The U.S. Food and Drug Administration recently issued a warning to the public not to purchase, or to immediately stop using, Dr. Berne’s MSM Drops 5% Solution and LightEyez MSM Eye Drops — Eye Repair due to a risk of bacterial contamination, fungal contamination, or both.There’s not just a risk of contamination: The FDA says that the drops also contain the ingredient methylsulfonylmethane (MSM), which is not approved for use in eye-related products in the U.S. If you have these eye drops, the FDA recommends following the agency’s guidance on safe disposal. The message also includes this warning: “Using contaminated eye drops could result in minor to serious vision-threatening infection which could possibly progress to a life-threatening infection.”There have been no adverse event reports linked with either drops at this time, per the FDA, but the agency recommends that anyone who has signs or symptoms of an eye infection talk to their healthcare provider or seek medical care immediately. The FDA says the contamination was discovered during sampling and testing on the drops “due to the industry’s recent manufacturing issues with eye drops.” The tests found that the drops “were contaminated with microbes and were not sterile,” the FDA says, noting that “eye drops must be sterile to be safe for use.”This is hardly the first warning or recall of eye drops this year. And not every brand has been recalled due to bacterial contamination. So, what’s going on and which drops have been impacted? Here’s what you need to know, plus signs of an eye infection to look out for.What’s going on with eye drop recalls?If eye drop recalls seem popular right now—it’s not just your imagination. In May the U.S. Centers for Disease Control and Prevention noted 81 patients in 18 states with VIM-GES-CRPA, a rare strain of the drug-resistant Pseudomonas aeruginosa. Certain types of artificial tears have been named as a common exposure for many patients. So far, 14 patients have gone blind and an additional four had to have their eyeballs surgically removed. Despite these disturbing numbers, doctors stress that eye drop recalls have not been common in the past, and they’re incredibly rare in known brand names. “The vast majority of products available on the shelves in the United States are cleared by the FDA and subject to investigations if there is a safety issue with a product,” says optometrist Aaron Zimmerman, O.D., a clinical professor at The Ohio State University College of Optometry. “The recent recall this August, with two brands of artificial tears are illegally marketed in the U.S., as they contain an unapproved — for eye application — chemical,” Zimmerman says that in this case, the product shouldn’t even be on store shelves or online.The latest recall also contained bacteria—and the drops were not sterile, the latter of which is required for eye drops, Zimmerman says. In general, eye drops have been recalled over the past year due to either contamination or a lack of sterility. Both are major issues.What are the symptoms of eye infection?Many of the infections linked to eye drops are of the cornea, Zimmerman says. He says to look out for the following symptoms:Significant painSignificant light sensitivityBlurred visionRed eyesWatery-mucus dischargeSwelling around the eyeThere are several types of eye infections, though. The most common type is conjunctivitis (a.k.a. pink eye), the Cleveland Clinic explains. Symptoms can include:Red eyesItching or irritationEye painWatery eyesSwellingIf you have symptoms of an eye infection, Zimmerman says it’s important to seek care from an optometrist or ophthalmologist. “These individuals are trained and deal with eye infections regularly,” he says. “They can differentiate between viral, bacterial, and other infectious microbes and then treat them appropriately.”How to treat an eye infectionFirst and foremost, if you have been using any of the recalled products and think you may have an eye infection, speak with your healthcare provider ASAP. Next, if you suspect that you have an eye infection and wear contacts, it’s important to remove them and switch back to glasses, says Vivian Shibayama, O.D., an optometrist at UCLA Health. Treatment really depends on the cause of the infection, the Cleveland Clinic says, but may include: Damp, warm, or cool compresses Artificial tears Over-the-counter pain relievers Antibiotics (for bacterial infections)“If it is bacterial, such as the infections associated with the recalls, then a broad spectrum antibiotic eye drop is prescribed,” Zimmerman says. “The patient will instill drops hourly—sometimes even more often than that—until the ocular surface begins to improve. The patient will then be followed regularly until the infection has resolved.”The biggest concern is about post-infection corneal scarring, Zimmerman says. “This scarring can substantially impair vision and may result in a corneal transplant,” he points out. “If identified early and proper treatment occurs, then the risk of post-infectious scarring is much lower than if it were delayed.”List of eye drops recalled so far in 2023It can be hard to keep track of all the eye drops that have been recalled this year. Here’s a full list: Dr. Berne’s MSM Drops 5% Solution and LightEyez MSM Eye Drops–Eye Repair (August). The FDA issued a warning to consumers, noting that testing determined that the drops were not sterile and contained microbes. They also contained methylsulfonylmethane (MSM) as an active ingredient, which is unapproved for use in the U.S. EzriCare artificial tears March). These drops were linked to a multistate outbreak of an extensively drug-resistant strain of Pseudomonas aeruginosa, per the CDC. Keep an eye out for these manufacturing codes for EzriCare: NDC 79503-0101-15 and UPC 3 79503 10115 7.Delsam Pharma’s artificial tears and ointment (March). As a part of the same recall as EzriCare artificial tears, these drops were linked to a multistate outbreak of Pseudomonas aeruginosa, per the CDC. “The outbreak is associated with multiple types of infections, including eye infections,” the CDC noted in its initial warning. The Delsam Pharma Artificial Tears Lubricant Eye Drops will have the following codes: NDC 72570-121-15 and UPC 3 72570 12115 8. The Delsam Pharma Artificial Eye Ointment have the following codes: NDC 72570-122-35 and UPC code 3 72570 12235 3. Purely Soothing 15% MSM Drops (March). These drops were recalled after two lots were found to not be sterile. No illnesses were tied to the recall. These codes were part of the recall: LOT#: 2203PS01, UPC 7 31034 91379 9; and LOT#: 1808051, UPC 7 31034 91382 9. Clear Eyes Once Daily, Eye Allergy Itch Relief (February). Teva Pharmaceuticals recalled select batches of the eye drop after they failed an impurities test. More than 700,000 bottles were recalled with the following lot numbers: Lot 114349, Lot 117396, Lot 0120128, Lot 114371, and Lot 123781. Brimonidine Tartrate Ophthalmic Solution, 0.15% (March). These eye drops, which are intended to be used by people with glaucoma or ocular hypertension, had faulty caps that could lead to unsterile solutions, the FDA noted. Look for these identifying numbers: 60505-0564-1, 60505-0564-2, and 60505-0564-3.While this seems like a lot (and it is), Zimmerman says consumers should generally feel safe purchasing artificial tears from known brands. “Up until this year, I don’t recall ever hearing of an artificial tear recall in my career,” he says. “The majority of the products available on the shelves in stores are safe and the companies that manufacture them follow very stringent manufacturing processes.” Another pro tip, per Shibayama: “Don’t touch dropper to the eye.” This raises the risk you’ll contaminate your drops. And, if you’ve purchased single-use drops, she recommends actually following the instructions and tossing leftover drops after each use.What eye drops should I avoid?It’s also a good idea to check in with your doctor if you’re unsure of a brand, says Nandini Venkateswaran, M.D, an ophthalmologist and member of the Cornea and Refractive Surgery Service at Mass Eye and Ear. “I tell patients to look at a list that I provide them of the most commercially available artificial tear drops that we recommend and vet,” she says. “There are drops with and without preservatives. It’s just important to purchase the brands we know and trust.”Zimmerman agrees. “Don’t always purchase the least-expensive product and if you are finding that you can only find the product online or from another non-traditional vendor, or is not available in the United States, then pause and question whether you should be purchasing that product,” he says.

The list of eye drop recalls in 2023 keeps growing. The U.S. Food and Drug Administration recently issued a warning to the public not to purchase, or to immediately stop using, Dr. Berne’s MSM Drops 5% Solution and LightEyez MSM Eye Drops — Eye Repair due to a risk of bacterial contamination, fungal contamination, or both.

There’s not just a risk of contamination: The FDA says that the drops also contain the ingredient methylsulfonylmethane (MSM), which is not approved for use in eye-related products in the U.S.

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If you have these eye drops, the FDA recommends following the agency’s guidance on safe disposal. The message also includes this warning: “Using contaminated eye drops could result in minor to serious vision-threatening infection which could possibly progress to a life-threatening infection.”

There have been no adverse event reports linked with either drops at this time, per the FDA, but the agency recommends that anyone who has signs or symptoms of an eye infection talk to their healthcare provider or seek medical care immediately.

The FDA says the contamination was discovered during sampling and testing on the drops “due to the industry’s recent manufacturing issues with eye drops.” The tests found that the drops “were contaminated with microbes and were not sterile,” the FDA says, noting that “eye drops must be sterile to be safe for use.”

This is hardly the first warning or recall of eye drops this year. And not every brand has been recalled due to bacterial contamination. So, what’s going on and which drops have been impacted? Here’s what you need to know, plus signs of an eye infection to look out for.

What’s going on with eye drop recalls?

If eye drop recalls seem popular right now—it’s not just your imagination. In May the U.S. Centers for Disease Control and Prevention noted 81 patients in 18 states with VIM-GES-CRPA, a rare strain of the drug-resistant Pseudomonas aeruginosa. Certain types of artificial tears have been named as a common exposure for many patients. So far, 14 patients have gone blind and an additional four had to have their eyeballs surgically removed.

Despite these disturbing numbers, doctors stress that eye drop recalls have not been common in the past, and they’re incredibly rare in known brand names. “The vast majority of products available on the shelves in the United States are cleared by the FDA and subject to investigations if there is a safety issue with a product,” says optometrist Aaron Zimmerman, O.D., a clinical professor at The Ohio State University College of Optometry. “The recent recall this August, with two brands of artificial tears are illegally marketed in the U.S., as they contain an unapproved — for eye application — chemical,” Zimmerman says that in this case, the product shouldn’t even be on store shelves or online.

The latest recall also contained bacteria—and the drops were not sterile, the latter of which is required for eye drops, Zimmerman says. In general, eye drops have been recalled over the past year due to either contamination or a lack of sterility. Both are major issues.

What are the symptoms of eye infection?

Many of the infections linked to eye drops are of the cornea, Zimmerman says. He says to look out for the following symptoms:

  • Significant pain
  • Significant light sensitivity
  • Blurred vision
  • Red eyes
  • Watery-mucus discharge
  • Swelling around the eye

There are several types of eye infections, though. The most common type is conjunctivitis (a.k.a. pink eye), the Cleveland Clinic explains. Symptoms can include:

  • Red eyes
  • Itching or irritation
  • Eye pain
  • Watery eyes
  • Swelling

If you have symptoms of an eye infection, Zimmerman says it’s important to seek care from an optometrist or ophthalmologist. “These individuals are trained and deal with eye infections regularly,” he says. “They can differentiate between viral, bacterial, and other infectious microbes and then treat them appropriately.”

How to treat an eye infection

First and foremost, if you have been using any of the recalled products and think you may have an eye infection, speak with your healthcare provider ASAP. Next, if you suspect that you have an eye infection and wear contacts, it’s important to remove them and switch back to glasses, says Vivian Shibayama, O.D., an optometrist at UCLA Health. Treatment really depends on the cause of the infection, the Cleveland Clinic says, but may include:

  • Damp, warm, or cool compresses
  • Artificial tears
  • Over-the-counter pain relievers
  • Antibiotics (for bacterial infections)

“If it is bacterial, such as the infections associated with the recalls, then a broad spectrum antibiotic eye drop is prescribed,” Zimmerman says. “The patient will instill drops hourly—sometimes even more often than that—until the ocular surface begins to improve. The patient will then be followed regularly until the infection has resolved.”

The biggest concern is about post-infection corneal scarring, Zimmerman says. “This scarring can substantially impair vision and may result in a corneal transplant,” he points out. “If identified early and proper treatment occurs, then the risk of post-infectious scarring is much lower than if it were delayed.”

List of eye drops recalled so far in 2023

It can be hard to keep track of all the eye drops that have been recalled this year. Here’s a full list:

  • Dr. Berne’s MSM Drops 5% Solution and LightEyez MSM Eye Drops–Eye Repair (August). The FDA issued a warning to consumers, noting that testing determined that the drops were not sterile and contained microbes. They also contained methylsulfonylmethane (MSM) as an active ingredient, which is unapproved for use in the U.S.
  • EzriCare artificial tears March). These drops were linked to a multistate outbreak of an extensively drug-resistant strain of Pseudomonas aeruginosa, per the CDC. Keep an eye out for these manufacturing codes for EzriCare: NDC 79503-0101-15 and UPC 3 79503 10115 7.
  • Delsam Pharma’s artificial tears and ointment (March). As a part of the same recall as EzriCare artificial tears, these drops were linked to a multistate outbreak of Pseudomonas aeruginosa, per the CDC. “The outbreak is associated with multiple types of infections, including eye infections,” the CDC noted in its initial warning. The Delsam Pharma Artificial Tears Lubricant Eye Drops will have the following codes: NDC 72570-121-15 and UPC 3 72570 12115 8. The Delsam Pharma Artificial Eye Ointment have the following codes: NDC 72570-122-35 and UPC code 3 72570 12235 3.
  • Purely Soothing 15% MSM Drops (March). These drops were recalled after two lots were found to not be sterile. No illnesses were tied to the recall. These codes were part of the recall: LOT#: 2203PS01, UPC 7 31034 91379 9; and LOT#: 1808051, UPC 7 31034 91382 9.
  • Clear Eyes Once Daily, Eye Allergy Itch Relief (February). Teva Pharmaceuticals recalled select batches of the eye drop after they failed an impurities test. More than 700,000 bottles were recalled with the following lot numbers: Lot 114349, Lot 117396, Lot 0120128, Lot 114371, and Lot 123781.
  • Brimonidine Tartrate Ophthalmic Solution, 0.15% (March). These eye drops, which are intended to be used by people with glaucoma or ocular hypertension, had faulty caps that could lead to unsterile solutions, the FDA noted. Look for these identifying numbers: 60505-0564-1, 60505-0564-2, and 60505-0564-3.

While this seems like a lot (and it is), Zimmerman says consumers should generally feel safe purchasing artificial tears from known brands. “Up until this year, I don’t recall ever hearing of an artificial tear recall in my career,” he says. “The majority of the products available on the shelves in stores are safe and the companies that manufacture them follow very stringent manufacturing processes.”

Another pro tip, per Shibayama: “Don’t touch [the] dropper to the eye.” This raises the risk you’ll contaminate your drops. And, if you’ve purchased single-use drops, she recommends actually following the instructions and tossing leftover drops after each use.

What eye drops should I avoid?

It’s also a good idea to check in with your doctor if you’re unsure of a brand, says Nandini Venkateswaran, M.D, an ophthalmologist and member of the Cornea and Refractive Surgery Service at Mass Eye and Ear. “I tell patients to look at a list that I provide them of the most commercially available artificial tear drops that we recommend and vet,” she says. “There are drops with and without preservatives. It’s just important to purchase the brands we know and trust.”

Zimmerman agrees.

“Don’t always purchase the least-expensive product and if you are finding that you can only find the product online or from another non-traditional vendor, or is not available in the United States, then pause and question whether you should be purchasing that product,” he says.