Optical bodies issue advice for primary care optometry in patient safety alert

The MHRA has issued a patient safety alert in response to reports of increased IOP in patients recently implanted with EyeCee One preloaded and EyeCee One Crystal preloaded intraocular lenses

Optometrist and patient
Getty/Stevica Mrdja/EyeEm

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a patient safety alert after becoming aware of cases of increased intraocular pressure (IOP) in people recently implanted with the intraocular lenses (IOLs): EyeCee One preloaded and EyeCee One Crystal preloaded.

A Field Safety Notice has been disseminated by manufacturer Nidek, which is distributed by Bausch + Lomb UK Ltd.

Optometry membership bodies including the AOP have published the alert, along with a list of frequently asked questions for primary eye care providers.

The MHRA has written to cataract clinics and instructed them to contact every person who has been implanted with this lens since 1 October 2022. Initial reports suggest 2–4% of people fitted with this lens since October experience increased IOP.

The MHRA has told ophthalmology and ophthalmic theatres to stop using the identified products immediately and quarantine any remaining stock of these lenses until further notice.

Each clinic will make local arrangements for IOP to be assessed in every patient, and plans to carry out these checks may utilise primary care optometry clinics. The AOP shared in an alert, though more details of how this would be managed are still to be confirmed.

The cause and mechanism for the increase in IOP has not been identified, with investigations ongoing.

IOLs implanted prior to October are not thought to be affected, and historically the lens has an established and well-published safety record, the AOP notice states.

Primary eye care providers have been advised to read the MHRA notification and the NPSA.

Practitioners are encouraged to advise any anxious patients that plans are being put in place to review everyone who received these IOLs, and direct people who are concerned to their cataract clinic, as well as reassuring those not affected by this product. Any advice given should be recorded on the record card.

Eye care providers should continue to see patients as normal, member bodies advised, “for example, if somebody reports a concern, you can see them early and refer appropriately.”

Practices are recommended to keep up to date with sector news for further developments in the coming weeks, and to follow clinical updates.

Read more on this, and the information for primary care optometry, here.

Update: further advice for primary eye care

Optical membership bodies issued a joint update on 8 February sharing further advice for primary eye care on the recent patient safety alert.

The update includes guidance on what to tell patients who enquire about the IOL recall or have an IOP check, what to do if a patient needs an IOP check on a home visit, and advice on record-keeping.

The advice outlines actions practitioners should take if they discover a patient with signs and symptoms associated with the patient safety alert.

NHS England has also outlined information on funding, where enhanced primary eye care pathways are not yet commissioned. Primary eye care in Northern Ireland, Scotland and Wales have had similar correspondence about utilising existing NHS-funded services to respond to the emergency, membership bodies said in the update.

Read the new guidance in full on the AOP website.

This article was updated on 8/2/2023 to reflect a joint update from the optical membership bodies with further advice for primary eye care.