Intraocular lenses spark patient recall following cataract surgery

[ON 26 JANUARY the Medicines and Healthcare products Regulatory Authority (MHRA) issued Device Safety Information regarding EyeCee One preloaded and EyeCee One Crystal preloaded intraocular lenses (IOLs). The MHRA had been made aware of cases of increased intraocular pressure (IOP) in patients recently implanted with the lenses.

That was followed on 1 February by a national Patient Safety Alert. The alert was issued following consultation with the Royal College of Ophthalmologists (RCOphth), the College of Optometrists and the National Clinical Director for Eye Care.

Initial reports suggest that 2-4% of people fitted with the lenses since October last year experience increased IOP. The MHRA has consequently written to cataract clinics and instructed them to contact – preferably by phone – every person who has been implanted with those lenses since that date. Each clinic will make local arrangements for IOP to be assessed in every patient.

According to a statement from the College of Optometrists, IOLs implanted prior to October are not thought to be affected, and historically the lens has an established and well-published safety record. The cause and mechanism for the increase in IOP has not been identified and further investigations are on-going. Optometrists should ensure that they follow clinical updates.

The RCOphth has been in discussion with clinical leads from some of the centres impacted by the alert and together they have devised a number of consensus points for prioritising, screening and treating patients affected.

In a statement the RCOphth said: “These incidents will place a significant burden upon the affected departments and the college will continue to work with the MHRA, NHS Patient Safety teams and our members to provide advice and guidance on managing the situation.

“The college will facilitate the sharing of information between affected departments with regards to patient contact, screening strategies and the management of affected patients.”

Patients who are concerned are advised to contact the eye unit that carried out their recent cataract surgery. q