Skip to content

Is there a problem with carbomer eye gel? Understanding Recalls, Safety, and Common Side Effects

3 min read

In November 2023, specific batches of carbomer eye gel were recalled in the UK due to potential microbial contamination with the bacteria Burkholderia cenocepacia. This major safety action prompted widespread concern and led many users to question: is there a problem with carbomer eye gel?

Quick Summary

Recent recalls of specific carbomer eye gel batches were prompted by potential bacterial contamination, though most products remain safe. The article covers side effects, risks, and provides critical safety guidance for patients.

Key Points

  • Microbial Contamination Recalls: In November 2023, specific batches of carbomer eye gel were recalled in the UK due to potential contamination with Burkholderia cenocepacia bacteria.

  • Most Products Are Safe: The recall was for specific batches, and regulatory bodies have since confirmed that most carbomer eye gel products available on the market are safe for use by the general public.

  • Common, Mild Side Effects: Most side effects, such as temporary blurred vision, mild stinging, and sticky eyelids, are temporary and manageable.

  • Increased Risk for Vulnerable Patients: High-risk groups, including patients with cystic fibrosis and those who are immunocompromised, were most at risk from the contaminated batches and should consult a doctor.

  • Potential for Allergic Reactions: Rare allergic reactions can occur, often linked to preservatives, and will resolve when the medication is discontinued.

  • Environmental Concerns: Carbomers are sometimes classified as microplastics, raising environmental impact concerns, though they are generally considered non-toxic to humans.

  • Consult a Doctor for Worsening Symptoms: If eye symptoms worsen or infection is suspected, contact a healthcare professional immediately and inform them of the product being used.

In This Article

Carbomer Eye Gel: Function and Use

Carbomer eye gel is a synthetic polymer used as a tear substitute to treat dry eye syndrome. It lubricates the eye's surface, easing symptoms like burning and irritation. Its high viscosity provides long-lasting relief with fewer applications than less viscous drops. While effective, its safety has recently been questioned.

The 2023 Recalls and Contamination Incident

In November 2023, the MHRA in the UK recalled specific batches of carbomer eye gels due to a potential link to Burkholderia cenocepacia infections investigated by the UKHSA. Recalled brands included AaCarb®, Aacomer®, and Puroptics®.

Who Was Affected?

Though generally low risk, certain patient groups were more susceptible to adverse effects from the bacteria. These included individuals with cystic fibrosis, those in critical care, severely immunocompromised patients, and those awaiting lung transplants.

By April 2024, the MHRA updated guidance, confirming most carbomer eye products were safe, lifting restrictions for high-risk individuals except for the specific recalled batches. This indicates the issue was isolated to specific manufacturing batches, not the ingredient broadly.

Common Side Effects of Carbomer Eye Gels

Even safe products can cause side effects, distinct from recall risks. These common effects are usually mild and temporary, often due to the gel's thickness.

Common Side Effects (affecting fewer than 1 in 10 people):

  • Temporary blurred vision.
  • Mild, brief stinging.
  • Sticky eyelids.
  • Eye redness, discomfort, or irritation
  • Matting or sticky eyelashes

Less Common Side Effects (may affect up to 1 in 100 people):

  • Eye swelling
  • Eye pain
  • Itchy eye
  • Increased tear production

Other Potential Concerns

Other issues associated with carbomer eye gels include:

Benzene Impurity

Benzene, a known toxic agent, has been noted as a potential impurity in carbomer manufacturing. Regulatory bodies advise reducing its concentration, but it remains a concern.

Allergic Reactions

Some users may react to preservatives like cetrimide or benzalkonium chloride. Reactions usually stop upon discontinuing the gel.

Environmental Impact

Carbomers are sometimes classified as liquid microplastics due to poor biodegradability. Their long-term environmental impact is being studied.

Comparing Carbomer Eye Gel to Other Eye Lubricants

Eye lubricants vary. Here's a comparison of carbomer gel with other common types:

Feature Carbomer Eye Gel Polyvinyl Alcohol (PVA) Drops Sodium Hyaluronate Drops
Viscosity High (gel) Low (liquid) High (visco-elastic)
Duration of Relief Long-lasting due to prolonged contact time Shorter duration, requires more frequent application Extended relief, often praised for comfort
Common Side Effects Temporary blurred vision, mild stinging, sticky eyelids Less blurring, but shorter duration of effect High patient satisfaction, but may still cause blurred vision
Best For Moderate to severe dry eyes, nighttime use Mild to moderate dry eye symptoms Moderate to severe dry eye, often with added benefits
Patient Satisfaction Effective, but can have more pronounced side effects Generally well-tolerated, but less effective for severe cases High, with some studies showing higher appreciation scores

Conclusion

Is there a problem with carbomer eye gel? Generally, it is a safe and effective treatment for dry eye. The 2023 recalls were due to specific contaminated batches, emphasizing the need for vigilance. Common side effects are usually mild. However, the risk of microbial contamination, even if rare and linked to manufacturing issues, highlights the importance of caution, especially for high-risk patients. Always stay informed about recalls and consult a healthcare professional for concerns or worsening symptoms. Awareness of both common effects and less frequent risks helps users make informed decisions with their doctor. For official recall details, refer to regulatory body websites like the UK's MHRA. GOV.UK recall notice

Frequently Asked Questions

Specific batches of carbomer eye gel were recalled in the UK in late 2023 due to the potential for microbial contamination with the bacteria Burkholderia cenocepacia, following an investigation by the UK Health Security Agency.

No, not all carbomer eye gel is unsafe. The recall applied to specific manufacturing batches of certain brands. As of April 2024, regulatory bodies have stated that most carbomer-containing eye products on the market are safe for the general public, with the exception of the recalled batches.

The most common side effects include temporary blurred vision, a mild stinging sensation upon application, and sticky eyelids. These are usually mild and resolve on their own.

You should remove soft contact lenses before using carbomer eye gel, as some brands contain preservatives that can affect the lenses. Wait at least 15 minutes before reinserting them, or as advised by your doctor.

Individuals with cystic fibrosis, patients in critical care, severely immunocompromised patients, and those awaiting lung transplants were identified as having a higher risk from the bacterial contamination.

You should immediately stop using the product and return it to the retailer or supplier. If you experience worsening eye symptoms, contact a healthcare professional and inform them you were using a recalled product.

Yes, many alternative eye lubricants are available. These include eye drops containing different agents like polyvinyl alcohol or sodium hyaluronate. Your doctor can help you find a suitable non-carbomer alternative if necessary.

References

  1. 1
  2. 2
  3. 3
  4. 4
  5. 5
  6. 6
  7. 7
  8. 8
  9. 9
  10. 10

Medical Disclaimer

This content is for informational purposes only and should not replace professional medical advice.