Safety warning for patients undergoing cataract surgery due to concerns that lenses may be associated with higher pressure causing vision loss.
Thousands of patients have been recalled for urgent eye exams after regulators raised concerns about the safety of a product used in cataract surgery.
About 20 trusts are believed to have suspended use of EyeCee One lenses after the Medicines and Health Products Regulatory Agency (MHRA) warned of a link to higher pressure in the eye that could lead to vision loss.
The MHRA has issued a warning directing trusts to recall patients who have had surgery since October.
An estimated 2 to 4 percent of patients may have complications.
No group of patients was seen to be at higher risk for high blood pressure, “although pre-existing ocular hypertension and glaucoma may be relevant,” he adds.
About 20 trusts have suspended the use of EyeCee One lenses after warnings of an association with higher intraocular pressure.
The watchdog stressed that vision loss can only occur if patients are left untreated, according to the Health Service Journal.
It is believed that the complications may be related to how the implant was used in surgery rather than the product itself.
A statement from the manufacturer, NIDEK, states: “A causal relationship between reports of elevated intraocular pressure and these products has not been identified.”
“NIDEK continues to investigate the causes of elevated intraocular pressure.”
A template letter to be sent to patients issued by the MHRA states: “There is some concern that a small number of patients who have received these lenses have been found to have elevated intraocular pressure over the past few months.
“High pressure in your eye can lead to damage to the optic nerve and loss of vision if left untreated.”
A patient safety alert issued last week gave service providers two weeks to contact patients for further tests and create a fast track for those found to have higher blood pressure.
One of the trusts using the product, the Hull University Teaching Hospitals Trust, is known to be inviting about 1,000 affected patients for testing this weekend.
An ophthalmologist consultant from another major foundation who used the lenses told HSJ: “There will be at least 20 major hospitals using the lenses.” [the lens] regularly, making several thousand a year each.
He said the complications could be related to how the implant was used in surgery rather than the product itself, adding: “We don’t think there is a problem with the lens, but for now we have completely stopped using it until all investigations have been carried out.
NHS England stated: “As a precautionary measure and following the advice of the MHRA, a minority of NHS trusts have suspended EyeCee One lenses used for cataract surgery while any patient who has had surgery using these products in recent months will contact their physician for estimates, but only a small proportion are expected to require further treatment.”
Alison Cave, MHRA Chief Safety Officer, said: “We are working closely with our healthcare partners, including the Royal College of Ophthalmologists and the National Health Service, to ensure that these lenses are not used for cataract surgery and to better understand the risks associated with them. …