Nearly 120,000 lenses implanted in the eye during cataract operations in France have a defect and may be responsible for ocular hypertonia, warns the Medicines Agency (ANSM).
Several thousand intraocular lenses implanted in the eye duringcataract operations in France present a quality defect and can be responsible for ocular hypertonia (increased pressure inside the eye), reports theMedicines Agency (ANSM) in a press release dated October 6, 2023. The main risk of ocular hypertonia is glaucoma. These lenses manufactured by companies Nidek Co Ltd (Eyecee One model) and STAAR Surgical Japan (model KS-SP) were placed on cataract surgery patients between December 10, 2021 and March 30, 2023. The quality defect concerns 60,000 Eyecee One lenses from Nidek Co Ldt and 59,000 lenses STAAR KS-SP implanted in French patients, i.e. almost 120,000 lenses. At the moment, no explantation of these lenses is planned. But as a precautionary measure, all affected lenses have been recalled from the implanting centers. They are not no longer available or used on the French market.
Effects often reported in the month following the operation
This quality defect is linked to a risk of particle release which can block the trabecular meshwork and prevent the aqueous humor contained in the eye from draining properly and thus lead ocular hypertonia that corresponds to an abnormal rise in pressure inside the eyeball. “This is an undesirable effect that can occur after any intraocular lens implantation. A greater frequency of occurrence was observed in patients implanted with these lenses. To date, the majority of cases of hypertonia have been reported in the month following cataract surgery“, specifies the ANSM. Ocular hypertonia does not necessarily result in visual disturbances, but it can evolve towards glaucoma and cause serious eye symptoms such as:
- Blurred vision
- Loss of vision (peripheral visual field)
- Eye pain
How do I know if I’m wearing these lenses? What to do ?
After your cataract surgery, your surgeon gave you a card mentioning the lens model which was implanted in you, the batch number and the date on which you had the operation. You are potentially affected if you were implanted with the model Eyecee One Nidek Co Ltd or the model KS-SP of STAAR Surgical Japan and operated on for cataracts between December 10, 2021 and March 30, 2023. If you are concerned:
► In the absence of symptoms, wait for the call from your implant center for the usual annual follow-up check recommended for cataract surgery patients.
► If you have any visual problem, contact your implant center or your ophthalmologist. In the event of adverse reactions, you can make a report on the Ministry of Health’s reporting portal.
Surgeons and ophthalmologists implanting centers are invited carefully monitor implanted patients. For this, the ANSM recommends planning a control visit for the patients concerned, then subsequently, an annual check. For any case of ocular hypertonia and/or appearance of glaucoma that is observed during one of the annual follow-up checks carried out on these patients, we invite you to make a report to the ANSM via the reporting portal.