Published: 29/07/2004, Volume II4, No. 5916 Page 6 7

A private company that carried out cataract operations for the NHS has been left£97,000 out of pocket after the device it used proved to be faulty.

Primary care trusts could also be forced to pay for further operations that may be needed where the devices did not work correctly.

Drayton House clinic in Southport carried out 214 lens replacement operations for three NHS providers in 2000-01.

It has since replaced 89 of these after they became cloudy, at a cost of more than£2,000 each. A further two patients currently need lens replacement and the remaining 123 patients require screening.

All operations used the AquaSense lens manufactured by US company Ophthalmic Innovations International. It was the subject of a medical device alert from the Medicine and Healthcare products Regulatory Agency in April.

But the importer, King's Lynnbased Ophthalmic Innovations International UK, has agreed to pay for only some of the corrective operations, and Drayton House has halted work. The clinic's contracts were with a GP fundholder in Chorley and Ribble, and North West Lancashire and Wigan and Bolton health authorities.

Drayton House business manager Marilyn Francis said: 'This is a very difficult situation. We were replacing the lens on behalf of our NHS contractors and initially OII was paying. But they have suddenly stopped.We have had to stop carrying out the replacements and are trying to recover the£97,000 we are owed by the company.'

Blackpool, Fylde and Wyre PCTs have agreed to pay for any further operations that may be needed for patients whose original operations were commissioned by North West Lancashire HA.

Bolton Hospitals trust surgery directorate manager Stephen Ashworth said replacement operations for patients whose original work was commissioned by Wigan and Bolton HA had been brought in-house. Three have been carried out.

He told HSJ: 'We have treated this as a serious untoward incident and have reassurance from OII that they will pay for the replacement lenses. So far we have not sought that payment.'

Solicitors in Preston have issued proceedings against OII UK on behalf of 20 patients seeking compensation under the Consumer Protection Act.

According to the Medical Device Alert the Aqua-Sense lens was used in 868 operations in the UK, with 233 needing replacement.

Many of these were in the NHS.

OII refused to comment but said a statement would be issued soon.