UK healthcare regulators have announced that they are to launch an investigation into complaints by a number of surgeons concerning serious problems encountered by their patients who underwent a supposedly revolutionary new vision procedure. The surgery involved the use of a new vision implant, and there are fears that thousands of people who had the surgery in the last year could be at risk.
The investigation was triggered by doctors who flagged up problems with a new lens which has been in use in the UK for just a year to the MHRA (Medicines and Healthcare Regulatory Agency).
The implant in question is called the Mplus X. It is designed to replace the need for wearing bifocal glasses for middle aged patients and is implanted during a surgical procedure.
Could thousands of patients in the UK be affected?
Britain’s leading sight specialists, Moorfields Eye Hospital in London, has sent a report to the official regulators after finding that out of six of its patients who had the surgery, four suffered from loss of sight. Both Moorfields and Optical Express are believed to be no longer using the lens in question.
In a statement, Optical Express said that the decision to stop using the lens was not connected with worries over its performance. At least 6,500 people are thought to have undergone the surgery through Optical Express in the 12 months since January 2014.
Optical Express also said that only 0.5% of the lenses which had been fitted needed removal at a later date, and said that if this model of lens was compared to one used previous, there were “no significant differences in any outcomes”.
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MHRA investigation pending
The MHRA confirmed that they were investigating any issues around the lens, and would take action if it proved necessary.
Speaking on behalf of Optical Express, a spokesperson reiterated that their number one concern was patient safety, and stressed that the number of patients reporting problems with distance vision was “a tiny minority”.
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