Dozens of patients ‘left with blind patches’ could sue a lens manufacturer after routine operation worsened their eyesight
- As many as 800 people are thought to have vision problems from the lenses
- The lenses, made by Oculentis, were used five to seven years ago for cataracts
- But calcium deposits have built up in people’s eyes and made their sight worse
Denise Di Battista, a painter, said she has become ‘almost blind’ in one eye because of a calcium build-up in her cataract lens
Dozens of people could sue a lens manufacturer after routine cataract operations made their eyesight worse.
As many as 800 patients are thought to have been affected by a problem with Oculentis lenses, which have become cloudy years after being implanted.
The company has already recalled the lenses which caused the issue. They are believed to have been on the market at least five years ago.
One woman involved in an upcoming lawsuit, Denise Di Battista, 68, said she was ‘very, very shocked’ to find out she would need another cataract operation to fix the issue.
There are believed to be hundreds of people suffering from opacification of their lenses – meaning patches of the eye’s lens become hard to see through.
The problem is affecting some of those whose natural lenses were replaced in cataract surgery, and has taken years to surface.
Cloudiness in the new lenses is caused by calcium deposits which build up over years until they become so large they obstruct people’s vision.
Ms Di Battista, a painter from Llanelli, Carmarthenshire, said she now has blind patches in one of her eyes, and struggles to see colours.
Problems began following an operation to replace both her natural lenses in 2010.
She said: ‘If I was looking through my right eye, at times, I would think I was almost blind. It affects my painting and that depresses me terribly.
‘I was very short-sighted and found it difficult to paint when taking my glasses on and off. I thought that if I had surgery it would correct the problem.
‘Immediately after the surgery it was excellent, but after a while I started getting some mistiness in my right eye.’
Hundreds of people are believed to be suffering from vision problems because they had cataract operations in which they were given lenses which later produced calcium build-up
A lawyer taking action against Oculentis on Ms Di Battista’s behalf said dozens more people are seeking similar compensation because of the problematic batch.
There are believed to be more than 100 pursuing legal action.
The company has already paid for surgeons to replace the lenses in patients who have been affected by the issue, which is the only way to repair the damage.
Lawyer Peter Todd, of the firm Hodge Jones & Allen said: ‘Mrs Di Battista has been left devastated by the deterioration in her sight since she had the Oculentis lens implanted.
‘She is one of dozens of people who we are representing in upcoming legal action.
WHAT ARE CATARACTS?
Cataracts occur when the lens – a small transparent disc inside the eye that helps to focus light – becomes cloudy.
The patches gradually become bigger over time, according to the NHS, and can lead to blurry vision and, in some cases, blindness.
Cataracts affect around half of over-65 in the UK. Some 24 million adults aged over 40 in the US suffer, according to figures.
The Royal College of Ophthalmologists last year warned that due to a rapidly ageing population, the number of required cataract operations is expected to jump by 50 per cent over the next 20 years.
Yet in his new book ‘The Complete Patient’s Guide to Cataract Surgery’, leading eye surgeon David Allamby claimed there simply will not be enough specialists to cope with the soaring demand.
He said around 1,300 NHS surgeons perform 389,000 operations a year. However, by 2035 more than 2,000 medics will be needed to do around 583,500 procedures annually.
People are more at risk if they have: diabetes, suffered an eye injury, take certain medications or have other eye conditions.
Symptoms normally develop very slowly and include being more sensitive to light and thinking everything looks washed out.
Cataracts can be removed by surgery and replaced with an artificial lens. No other treatment is available.
The Mail has long campaigned against the current unfair system for surgery in the UK, which were a postcode lottery until the health watchdog issued guidelines last August to tackle problem, which had led to many sufferers being denied the straightforward 30-minute operations.
‘All claim to have suffered similar experiences after having the lens implanted. We will be launching legal proceedings shortly.’
Cataract operations are the most common surgery done in the UK, with around 400,000 of them performed in the UK each year.
But having the lenses replaced for a second time carries a higher risk of complications, making surgeons and patients more reluctant to repeat the op.
Solicitor Karen Cathcart from the firm Devonshires, which is representing patients with the problem, said: ‘The cases are all quite similar in that the lenses were implanted some years ago and the clients have recently begun to notice a deterioration in their vision.
‘Some of our clients have now had the lenses (one or both) removed and others are very scared to have the surgery carried out as it carries a greater risk than the original surgery.
‘One client in particular has had one lens removed and is now left with worse vision in the eye than before they had the lens inserted.
‘They have not yet had the other lens removed and they are quite reluctant at this stage to have it removed due to the significant risk.’
The rate of people having problems with the lenses is ‘extremely low’, Oculentis said, and around half of people affected have already had successful replacement surgery.
It said the lenses in question are the Lentis Hydrosmart foldable intraocular lenses (IOLs) with model numbers starting with L, LU or LS
They have an expiry date between January 2017 and May 2020, and currently produced lenses or ones with later expiry dates are not affected.
A spokesperson for the Germany and Netherlands-based firm said: ‘Whilst there is no inherent defect in our Lentis lenses, post-market surveillance suggested a slightly increased rate of post-operative opacification some years after implantation in certain models and manufacturing years.
‘As a consequence, in 2014 and 2017 we issued Field Safety Notices (FSNs) on a voluntary basis, as a precautionary measure in relation to these lenses.
‘The incidence rate of opacification is extremely low.
‘In the rare event that it occurs and vision is disturbed, it can be effectively remedied through lens exchange surgery which is a safe and well-established procedure.’