Oculentis Reports Bankruptcy as Legal Challenges Mount Over Former Lenses Clouding

Intraocular lens maker Oculentis is in bankruptcy proceedings, according to an announcement posted on its website in Q3-2021.

The Netherlands-based company, headquartered in Germany until 2019, appears to have moved some of its executives and its LENTIS lenses to a new company, Netherlands-based Teleon Surgical, as Oculentis works through legal challenges tracing back to at least 2014.

Oculentis, formerly Acrimed before taking the name Oculentis in 2008, was an early innovator in lenses that provided an extended range of vision with its segmented presbyopia-correcting IOL, but the company ran into problems related to the lenses clouding.

It issued a voluntary recall of all IOL shelf stock in 2014 and 2017 due to increased rates of postoperative opacification in certain models of LENTIS Hydrosmart and foldable IOLs manufactured before May 2015.

Company analysis released in 2017 indicated the opacification was caused by phosphate remnants from a detergent used in the manufacturing process.

In January 2019, Oculentis responded to a new round of media reporting on the issue, saying LENTIS products on the market with an expiration date of June 2020 or later were unaffected.

It noted that 800 patients implanted with LENTIS lenses had reported opacification, and legal claims were mounting.

UK law firm Hugh James said on its website in October that Oculentis would be heading to trial in October 2022 to determine its liability related to the faulty products.

Oculentis’ website in October 2021 directed patients, doctors, and clinics to contact information if they wanted to report alleged defective lenses or seek compensation for reoperation costs.

The rest of the website had been removed.