Dave Berry | Partner

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

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 a wealth of experience dealing with medical product liability claims. We are acutely aware of the impact this particular product has had on patients and the implications on their sight. Please contact us today if you have been affected by this issue.

Dave Berry

Dave Berry

Personal Injury Team

“It may be something of a cliché but I enjoy helping my clients and guiding them through what can often be the daunting prospect of being involved in a personal injury court action, whilst also ensuring I obtain the best possible result for them.”

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