Serious Concerns Raised over the Safety of ‘Mplus X’ Lenses

Experts fear that more than 6,500 patients in Britain are thought to be at risk of blindness or impaired vision after having had their eyesight treated with the use of the Mplus X lenses.

The lenses are used for eyesight correction surgery where a patient’s lens is removed and replaced by an artificial plastic lens which is designed to better focus lights on the retina and therefore improve the patient’s vision.

Unfortunately, many who have had the Mplus X lenses have subsequently complained of fuzzy vision, floating lights in their eyes and poor sight at night.

The lenses, which are manufactured by a German company called Oculentis, went on sale just over a year ago and are already the first choice replacement lenses by the country’s leading eye surgery provider Optical Express.

A group of leading eye surgeons have contacted the Medical Health Regulatory Authority (“MHRA”) after receiving numerous complaints from patients about severe loss of vision after receiving the implant.

Moorfields Eye Hospital in London in particular has flagged such problems to the MHRA after two of it’s surgeons raised their concerns about the lenses.

A spokesperson for Moorfields Eye Hospital has released a statement saying: “Two surgeons had used these lenses in a very small number of patients, some of whom developed visual problems and required replacement of the lens. Moorfields reported concerns with this particular make of lens via the MHRA’s yellow card scheme. Moorfields Eye Hospital no longer uses this lens.”

A spokesperson for the MHRA has said: “We are currently investigating and will take action if necessary. If patients have any questions they should speak to their optometrist or surgeon.”

Since experts have raised safety concerns, both Oculentis and Optical Express have strenuously denied any fault with the product itself.

A spokesperson for Optical Express has said: “Every lens type that we use has passed a rigorous and time-consuming evaluation to make sure that it is both safe and effective. This includes the Mplus X lens, which is being used here in the UK by many providers and around the world. It is vitally important to stress that there have been no safety concerns whatsoever expressed about this lens. A tiny minority of patients are reported to have experienced poorer than expected distance vision, but the overwhelming majority have had their sight and their life significantly improved by having this lens implanted.”

A spokesperson for Oculentis confirmed they had received four incident reports from the MHRA and has stated: “We are currently in the process of analysing the facts, as all of these reports are very unspecific and unsubstantiated, only basically mentioning poor distance vision as the main complaint. The Mplus X is considered to be one of the better balanced intraocular lenses available and is used by many renowned surgeons whose opinions are generally based on medical evidence. We believe very strongly in the concept and it is by no means a ‘faulty’ model of lens.”

In addition to the safety concerns raised about the lenses themselves, there have also been concerns raised about possible failures by Optical Express to properly explain the risks of such eye surgery to their patients.

Private surgeon Sheraz Daya, who runs the Centre For Sight in London, has called for better regulation of High Street corrective eye clinics saying: “The major problem here is that model of care is ‘pile them high, sell them cheap’. You have eye surgery being sold in heavily marketed, time-limited offers. These are complicated procedures, but they are being sold like they are TVs or second-hand cars. The regulations are there but they are not being enforced.”

To date, over 50 patients who have suffered with problems with the lenses have joined together in legal action against both Oculentis and Optical Express. This litigation is ongoing but it is anticipated that many more people may also pursue similar legal action as the issues become more publicised and whilst the use of the lenses by Optical Express and other clinics is ongoing.

Those suffering with problems with the Mplus X lenses or other types of replacement lenses may be able to claim compensation, including the cost of revision treatment on a private paying basis from either the manufacturer of the lenses and/or the clinic where the treatment has been carried out.

The legal position for those who have suffered, or who are suffering, with product related injury claims is complex. Michael Lewin Solicitors are specialists in these types of claims and are able to advise and assist you in respect of a claim.  

If you believe that you would benefit from legal advice on this matter or believe you may have a claim relating to this type of product or any other product, please call us on 0844 499 9302 or email enquiries@michaellewin.co.uk.

 

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