In December 2014, the German company Oculentis GmbH has issued an urgent field safety notification and voluntary recall of its intraocular lenses product known as the LENTIS HydroSmart Intraocular lenses.
This follows reports of opacification (ie cloudiness) after surgical implantation causing loss of sight.
The company says that there could have been a manufacturing problem with some types of the lenses which were packaged in glass vials and manufactured before 31st December 2011.
About 120,000 people a year in the UK have eye surgery which sometimes involves replacement of natural lenses with this device. Many of these people have been persuaded to undergo eye surgery costing thousands of pounds, only to find their vision has been adversely affected, rather than improved.
Reports in the press have included statements by an eye surgeon, employed by Optical Express for 4 years who said he expressed concerns to his employer about vision problems with the Mplus X lens. This lens was sold as the “premium product”. He says he filed a report with the appropriate Regulatory authority.
So far about 50 patients have contacted solicitors intending to bring claims for compensation. Leading London eye hospital, Moorfields, has said it reported concerns and is no longer using this type of lens.
A spokesman for the UK Medicines & Healthcare Regulatory Authority says they are investigating.
Peter Todd, a solicitor and partner of Hodge Jones & Allen solicitors and a leading claimant product liability specialist, commented on this as follows:-
“It now seems inevitable that there will be claims for compensation by consumers adversely affected by the apparent manufacturing defect with certain types of this prosthetic lenses. The law assists consumers to obtain redress because it is not necessary for consumers to prove the manufacturer was negligent. Liability for injury will be imposed on the manufacturer if the product is “defective” within the meaning of the Consumer Protection Act 1987, which depends on whether the product was as safe as consumers were reasonably entitled to expect.
In this case the manufacturer has admitted that there is an apparent manufacturing defect which may result in poor vision and in this case I would suggest consumers affected would have a good prospect of success.
Product liability claims in relation to defective products can be challenging so consumers should seek appropriate specialist advice and representation.
I would be happy to advise anyone affected by this issue to contact me for a free consultation and claims assessment.”
Peter Todd can be contacted by email email@example.com, direct line 02078748467 or mobile 07824437466 or via Hodge Jones & Allen Solicitors, 180 North Gower Street, London NW1 2NB.