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| Top eye clinic faces claims over ‘faulty’ model of lens | Top eye clinic faces claims over ‘faulty’ model of lens |
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| This article is the subject of a legal complaint made by Oculentis B/V. | |
| The multibillion-pound corrective eye surgery industry has been thrust into the spotlight as regulators announced they were investigating claims that a new artificial lens implanted into the eyes of thousands of patients had caused serious loss of vision. | The multibillion-pound corrective eye surgery industry has been thrust into the spotlight as regulators announced they were investigating claims that a new artificial lens implanted into the eyes of thousands of patients had caused serious loss of vision. |
| Officials have launched their inquiry after a number of concerned surgeons submitted testimony that patients had complained of defective vision, with some, according to one doctor, struggling to see clearly beyond the outstretched length of their arms. | Officials have launched their inquiry after a number of concerned surgeons submitted testimony that patients had complained of defective vision, with some, according to one doctor, struggling to see clearly beyond the outstretched length of their arms. |
| Around 120,000 people seeking a life without glasses undergo corrective eye surgery every year either by laser or, often in the case of the over-50s, through the replacement of their natural lenses through surgery. | Around 120,000 people seeking a life without glasses undergo corrective eye surgery every year either by laser or, often in the case of the over-50s, through the replacement of their natural lenses through surgery. |
| It is believed that over the last year many thousands were fitted with the Mplus X lens in a boom time for the industry fuelled by marketing and the promise of interest-free credit on bills, which can be in excess of £3,000 an eye. | It is believed that over the last year many thousands were fitted with the Mplus X lens in a boom time for the industry fuelled by marketing and the promise of interest-free credit on bills, which can be in excess of £3,000 an eye. |
| The lens in question, manufactured by German company Oculentis and introduced into the UK last January, was supposed to offer an improved performance on previous models. | The lens in question, manufactured by German company Oculentis and introduced into the UK last January, was supposed to offer an improved performance on previous models. |
| The Observer has learned, however, that Moorfields Eye Hospital NHS Trust, the largest ophthalmic centre in Europe, submitted an official report about the lens after four of its six patients who had had the implant reported a worrying loss of quality of vision. | The Observer has learned, however, that Moorfields Eye Hospital NHS Trust, the largest ophthalmic centre in Europe, submitted an official report about the lens after four of its six patients who had had the implant reported a worrying loss of quality of vision. |
| Oculentis’s chief executive, Ben Wanders, also confirmed that its Australian distributor had decided “this is not a lens for the Australian people” after complaints in that country from surgeons. | Oculentis’s chief executive, Ben Wanders, also confirmed that its Australian distributor had decided “this is not a lens for the Australian people” after complaints in that country from surgeons. |
| A surgeon who worked until December for the market leader in corrective eye surgery, Optical Express, claimed that he voiced concerns about the performance of the Mplus X lens in the UK to his then employer earlier last year. | A surgeon who worked until December for the market leader in corrective eye surgery, Optical Express, claimed that he voiced concerns about the performance of the Mplus X lens in the UK to his then employer earlier last year. |
| George Settas, who worked as a surgeon at Optical Express for four years, said: “I told them, on more than one occasion, that I had concerns regarding the performance of the Mplus X lens, as I felt that there were a lot more patients experiencing quality of vision problems with this lens than other lenses. Explanting – ie removing – such a lens is not an easy procedure at all. Concerned by what I felt was an increase in the number of explants with the Mplus X lens, I raised the issue within Optical Express. In the end I had to file a report with the appropriate regulatory authority.” | George Settas, who worked as a surgeon at Optical Express for four years, said: “I told them, on more than one occasion, that I had concerns regarding the performance of the Mplus X lens, as I felt that there were a lot more patients experiencing quality of vision problems with this lens than other lenses. Explanting – ie removing – such a lens is not an easy procedure at all. Concerned by what I felt was an increase in the number of explants with the Mplus X lens, I raised the issue within Optical Express. In the end I had to file a report with the appropriate regulatory authority.” |
| He added: “The patients were complaining that they couldn’t see clearly, usually at distance. Most were saying that they could read but that they could not see properly beyond their arm’s length, which was a bit surprising. You would not expect people to have a problem at that distance.” | He added: “The patients were complaining that they couldn’t see clearly, usually at distance. Most were saying that they could read but that they could not see properly beyond their arm’s length, which was a bit surprising. You would not expect people to have a problem at that distance.” |
| Optical Express confirmed that Settas did express concerns about quality of vision problems with the Mplus X lens but said that the surgeon’s experience was anecdotal while its scientific study of outcomes suggested there was no cause for concern. Settas also claimed that Optical Express only finally removed stocks of the Mplus X lenses from its clinics in late November, despite him raising concerns in September. | Optical Express confirmed that Settas did express concerns about quality of vision problems with the Mplus X lens but said that the surgeon’s experience was anecdotal while its scientific study of outcomes suggested there was no cause for concern. Settas also claimed that Optical Express only finally removed stocks of the Mplus X lenses from its clinics in late November, despite him raising concerns in September. |
| Optical Express’s clinical services director, Stephen Hannan, said that some banks of the lens remained in clinics and that concerns about the lens had not been the reason for the withdrawal of others. He denied that any concerns were raised by Settas until October. | Optical Express’s clinical services director, Stephen Hannan, said that some banks of the lens remained in clinics and that concerns about the lens had not been the reason for the withdrawal of others. He denied that any concerns were raised by Settas until October. |
| Hannan said that the company had concluded that there was no advantage in continuing to stock the new Mplus X version rather than the older model as it had similar outcomes. He said: “The Mplus X lens has excellent ocular outcomes for patients. Our experience and detailed assessment of these ocular outcomes confirms this to be the case.” | Hannan said that the company had concluded that there was no advantage in continuing to stock the new Mplus X version rather than the older model as it had similar outcomes. He said: “The Mplus X lens has excellent ocular outcomes for patients. Our experience and detailed assessment of these ocular outcomes confirms this to be the case.” |
| On Saturday lawyers who represented a 28-year old-woman to whom Optical Express was ordered to pay £500,000 in damages in September after her eyes were left so damaged by laser eye surgery that she has to wear sunglasses during the day said 45 complainants against the firm had contacted them since the case, and that some had been fitted with the Mplus X lens, which may form part of a class action. | On Saturday lawyers who represented a 28-year old-woman to whom Optical Express was ordered to pay £500,000 in damages in September after her eyes were left so damaged by laser eye surgery that she has to wear sunglasses during the day said 45 complainants against the firm had contacted them since the case, and that some had been fitted with the Mplus X lens, which may form part of a class action. |
| Nick Grant, a partner at Devonshires solicitors, said: “I think there will be further individuals seeking to make a claim against Optical Express and expect that, based on the number of claims coming in, Devonshires will be bringing a class action against Optical Express in the near future on this Mplus X lens issue. Devonshires are currently obtaining copies of clients’ medical records before reviewing and instructing an expert to prepare a report. My advice is that anyone who thinks they may have been given an Mplus X lens and had a disappointing outcome should seek legal advice.” | Nick Grant, a partner at Devonshires solicitors, said: “I think there will be further individuals seeking to make a claim against Optical Express and expect that, based on the number of claims coming in, Devonshires will be bringing a class action against Optical Express in the near future on this Mplus X lens issue. Devonshires are currently obtaining copies of clients’ medical records before reviewing and instructing an expert to prepare a report. My advice is that anyone who thinks they may have been given an Mplus X lens and had a disappointing outcome should seek legal advice.” |
| A spokesman for the Medical Health Regulatory Authority said: “We are currently investigating and will take action if necessary.” | A spokesman for the Medical Health Regulatory Authority said: “We are currently investigating and will take action if necessary.” |