Oculentis has reacted to a BBC News article documenting cases of blind patches among patients using its intraocular lens products.
Artist Denise Di Battista told the BBC she had experienced blind patches in her right eye, with her lawyer explaining she was one of dozens being represented in upcoming legal action.
Oculentis said the report related to increased rates of post-operative opacification for certain models of its LENTIS lenses manufactured before May 2015.
These included LENTIS Hydrosmart foldable intraocular lenses (IOLs) in glass vials carrying the CE 1275 number, and the LENTIS foldable IOLs with model numbers starting with L, LU or LS having an expiry date from 2017-01 until 2020-05. It added that current products on the market were unaffected.
In 2014 and 2017, Oculentis issued Field Safety Notices (FSNs) on a voluntary basis as a precautionary measure in relation to these lenses.
A statement added: 'In issuing the FSNs we complied with industry best practice and all regulatory requirements, liaising with the appropriate national regulators regarding the exact content of the FSNs and the actions required.
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