Oculentis released a statement in response to recent articles published in The Observer and other news outlets concerning the safety of the Lentis Mplus X IOL. The company maintained in a news release that the statements made against its product, mostly reports that it has caused serious loss of vision, are “either entirely untrue or seriously misleading.”
The safety concerns reported in the media focus mostly on procedures performed at the UK-based refractive surgery chain Optical Express. According to Oculentis, The Observer has, over the years, printed several critical articles about Optical Express. “Unfortunately, in addition to the general refractive laser business, our product has now also been drawn into this dispute,” the Oculentis statement reads.
According to a response from Optical Express, quoted in The Observer article, although one patient in question had “an issue with higher-order aberrations” including halos and poor night vision after implantation of the Mplus X, the end result was “a very good ocular outcome.” The chain also commented that “in almost every case these symptoms subside,” they are not lens specific, and just 0.5% of all multifocal IOLs, including the Mplus and Mplus X, implanted in its practices require removal.
In Oculentis’ statement, the company also responded to what it called “several factual inaccuracies” contained in The Observer articles. The company stated that it was aware of a total of four reports having been made to the Medicines and Healthcare products Regulatory Agency (MHRA). The first report, from Moorfields Eye Hospital in London, has been closed by the MHRA, and the three others, made in December 2014, “lacked detail” but are reportedly being investigated by the company. Oculentis has not received an incident report from any other authority in the EU, the news release said.
Additionally, Oculentis stated that no regulator, independent scientific body, or expert has ever suggested that Mplus X lenses are “faulty.” The company maintained that the lenses comply with all relevant safety and regulatory standards and acknowledged that, as with any surgery, complications arise in a minority of patients. “Oculentis sincerely regrets if the two individuals referred to [in The Observer articles] have not achieved the improvements which they expected as a result of the surgery they have undergone, but the anecdotes of two individuals cannot in any way justify an assertion that the lens itself which they have been prescribed is faulty,” the news release states.
Oculentis questioned whether some of the claims made against the Mplus X were a result of competition in the business and industry, rather than rooted in factual evidence.
According to the company, several comments from CEO Ben Wanders were taken out of context by the media. Oculentis said that the countries mentioned by Mr. Wanders as examples of varying patient and surgeon preference were not in reference to cultural issues. Further, “suboptimal outcomes may be traced back to a multitude of reasons and cannot be automatically classified as a mistake by the surgeon, as suggested by the journalist.”
Oculentis confirmed that it has not withdrawn the product from any market worldwide.
1. Boffey D. Top eye clinic faces claims over “faulty model of lens.” The Observer. January 3, 2015. https://www.theguardian.com/society/2015/jan/03/wanted-better-eyesight-but-all-blurred-now. Accessed January 6, 2015.