Oculentis Responds to BBC Story on Opacification Related to Old IOL Models

Oculentis again is facing negative media coverage in the UK over lens opacification in patients who received hydrophilic LENTIS lenses that the company no longer manufactures.

The German company issued a statement Jan. 14 reacting to a BBC story on patients who had experienced reduced vision, including a landscape artist who underwent surgery in 2010. The article said 800 patients implanted with LENTIS lenses have reported opacification, and at least two law firms are representing unhappy patients.

Oculentis said the story related to slightly increased rates of postoperative opacification identified in certain models of LENTIS Hydrosmart and foldable intraocular lenses (IOLs) manufactured before May 2015.

The company said it issued a voluntary recall of all shelf stock in 2014 and 2017.

Oculentis said its currently produced LENTIS products and all products on the market with an expiration date of June 2020 or later are unaffected.

The company conducted analysis released in 2017 that indicated the opacification was caused by phosphate remnants from a detergent used in the manufacturing process.

Richard Packard, MD, who participated in the analysis, told OSN Europe for its February 2018 edition that the problem appeared to be solved, but the company was moving away from hydrophilic lenses and planned to launch a new hydrophobic IOL.

Packard said he expected to see hydrophilic lenses gradually disappear, given that recent research seemed to indicate every hydrophilic lens would ultimately opacify.