Hannah Tough | Paralegal

Recall of NIDEK CO.LTD EyeCee ONE and EyeCee ONE Crystal Pre Loaded Intraocular lenses (IOLs)

Start your claim

In January 2023, cases were reported of increased intraocular pressure in patients recently implanted with EyeCee One preloaded and EyeCee One Crystal preloaded IOLs manufactured by NIDEK Co. Ltd. The lenses were mainly used in patients undergoing eye surgery for cataracts.

On 1 February 2023, the MHRA issued a National Patient Safety Alert (NatPSA/2023/003/MHRA) asking that all patients implanted with these devices since October 2022 be recalled, to have their intraocular pressure checked.

In July 2023 NIDEK issued a recall of EyeCee ONE and EyeCee ONE Crystal Pre Loaded IOLS produced between September 2021 and November 2022. A manufacturing problem was identified with the coating on the injector used to help administer the lens. This coating had been found to obstruct the natural drainage pathways in the eye, which was the likely causal factor of increased intraocular pressure in some patients fitted with lenses manufactured between these dates.

Advice from the MHRA is patients found to have normal intraocular pressure do not require further follow-up, as the increased pressure occurs in the period covered by general postoperative management after cataract surgery. They should continue to have regular sight tests with their optometrist.

Patients who were found to have high intraocular pressure should continue to be seen by an appropriate specialist for treatment and monitoring.

What is High Intraocular Pressure?

High Intraocular Pressure (IOP), or Ocular Hypertension as it is commonly known, is where a fluid drainage failure causes high pressure within the eye. Your eyes constantly make a clear fluid called aqueous humor which flows in front of your eye and then drains out. Normally, an equal amount goes in and out. If this fluid does not leave your eye when it should, then the pressure within the eye increases.

The tricky thing about ocular hypertension is that it generally doesn’t cause symptoms. In some cases however, you may feel eye pain with movement of your eyes or touching your eyes. Your healthcare provider can do a test to check if the pressure inside your eye is at a normal level.

Ocular hypertension can cause glaucoma. Glaucoma happens when high IOP damages the optic nerve. These nerves in both eyes connect directly to your brain and transmit electrical signals that your brain turns into images. If you have glaucoma that’s not treated, you can lose your vision.

Can I make a claim if I have been impacted by defective EyeCee One Lenses?

If you have been affected by defective EyeCee ONE lenses, our expert lawyers are here to help. We have prior experience in dealing with this issue and are aware of the impact this has had on those worried about the reports of increased pressure in the eye, and its implications for their sight. Please contact us today if you have been affected by this issue.

Start your claim
Hannah Tough

Hannah Tough

Personal Injury Team

Contact us Share this page

Request a free call back

Our specialist lawyers will call you back at your preferred time to discuss your situation and explain how we can help.

Request Call Back

What our clients say about us

Read more