Advanced Medical Optics has recalled 2.9 million units of its Complete MoisturePlus multipurpose contact lens solution in the Asia-Pacific region and the US following a production line issue at its plant in Hangzhou, China.
On Tuesday the US firm announced that, after the discovery of three non-sterile production lots in Japan, it was implementing the voluntary recall as a precautionary measure.
AMO UK said that the recall did not in any way affect Complete MoisturePlus solution in Europe as it is supplied from the production plant in Madrid. 'Please be reassured that this unfortunate event was a temporary production issue and is not related to our formulation which has been used succesfully for many years in our markets.
'Our first priority is protecting patients' ocular health. We remain fully committed to providing you with products that meet the highest standards for sterility, product effectiveness and patient safety,' it said.
The recall relates predominately to Asia. Around 183,000 12oz bottles of Complete MoisturePlus are being recalled in the US, less than 1 per cent of total annual supply. Most of the US market is supplied from Spain.
Bacterial contamination found in three product lots in Japan led to sterility problems being identified at two of the four production lines at the China facility.
Product lots from these production lines are the subject of the recall, but manufacturing at the whole plant has now ceased so it can be sanitised.
AMO anticipated the recall would reduce revenue by $40-45m, due to product returns, supply shortages and reduced market share. Its share price fell around 12 per cent on the news.
Chairman, president and chief executive Jim Mazzo said: 'While we believe the likelihood of patients experiencing an adverse reaction is low based on our investigation to date, we are implementing this voluntary recall as a precautionary measure. We are working aggressively to replace recalled product and minimise the inconvenience this action may cause.'