Oculentis B.V. has been declared bankrupt by order of the District Court Gelderland of September 6, 2021. Mr. E.R. Looijen is the bankruptcy trustee, and Mr. M.J.C. van Leeuwen is the delegated judge.
Bankruptcy was no surprise, as the company had been grappling with legal issues over its faulty intraocular lenses over the last seven years. Optical Express, where the majority of these lenses were implanted, also faced legal disputes in line with the company.
In December 2014 and in 2017, the German company Oculentis B.V. issued an urgent field safety notification and voluntary recall for their LENTIS HydroSmart and Mplus X Intraocular lenses, the latter being sold as a “premium product” at the time.
This was because the intraocular lenses implanted in thousands of patients resulted in opacification (cloudiness) after surgical implantation, causing serious loss of sight rather than improving the vision of patients.
The company claimed that there could have been a manufacturing problem, which caused a reaction with calcium phosphate deposits on and below the surface resulting in opacification of the lens.
Officials launched an investigation after a number of concerned surgeons testified that patients had complained of poor vision, with some struggling to see well beyond the length of their arms, according to one doctor.
Thousands of people are said to have been fitted with the Mplus X lens in 2014, fuelled by heavy marketing and the promise of interest-free credit on costs that can exceed £3,000 per eye. Many of the patients then found their vision deteriorated rather than improved after paying thousands of pounds for the procedure.
The defective lens required surgical removal and replacement of the lens under general anesthetic. The lenses were said to last a lifetime. In many cases, the outcome after remedial surgery was poor with a permanent visual impairment and patients having to revert back to wearing glasses full time. Some people have suffered a loss of independence, according to media reports.
About 800 patients were believed to have been affected by Oculentis lens problems, the Daily Mail reported. Many patients contacted solicitors intending to bring claims for compensation.
For instance, lawyers who represented a 28-year old-woman to whom Optical Express was ordered to pay £500,000 in damages after her eyes were left so damaged by laser eye surgery that she has to wear sunglasses during the day.
The legal dispute then turned to a class action, with law firms across the U.K. have started to accept claims against Oculentis over accusations of its artificial lenses becoming cloudy over time.
If the case is successful, qualified Class Members will receive compensation for the problems surrounding the faulty lenses. The amount each Class Member will receive will be assessed by the Court.
Pressured by the mounting claims and legal fees, the company inevitably filed for bankruptcy. Prior to the bankruptcy Oculentis B.V. had been granted suspension of payments.
If you are a patient, doctor, medical clinic or other health care professional such as a distributor and you would like to report defective lenses, or seek compensation for reoperation costs, you can submit your claim through the email address firstname.lastname@example.org.