Sir,

We have read with interest the article published in a recent version of ‘Eye’ regarding ‘A Fungal ball in the irrigating solutions during phacoemulsification’ which makes reference to Alcon's 500 ml Balanced Salt Solution (BSS), and would like the chance to both comment on the article and to correct some information contained within it.

Alcon would like to emphasise their total commitment to the production of high-quality products. Alcon's products are produced under strictly controlled and inspected conditions, and all manufacturing sites adhere to the principles of Good Manufacturing and Distribution Practice (GMP/GDP), as well as to any additional local legislation covering these activities. A full Quality Assurance Inspection of each batch is conducted by the manufacturing facility before release of the product to the market, and extreme care is taken in every stage of the distribution chain to ensure that product is delivered to a customer in the best possible condition.

Alcon, as manufacturer was notified of this complaint on the 27th November 2002. Although the complaint sample was not returned for evaluation and confirmation of the defect, Alcon immediately performed a full and thorough investigation using the information available at the time, the results of which are listed below.

There were 17 500 other units manufactured in this lot, and review of our complaint records showed that there were no other reported or associated incidents with any other unit in this lot.

As additional assurance, we also reviewed the manufacturing batch records for this lot, which found no sterility problems associated with its production; and inspected retention samples, which showed no evidence of fungal growth.

The directions for use associated with this product, recommend ‘Do not use unless product is clear, seal is intact, vacuum is present and the container is undamaged’. As the author reports ‘…a hairline crack measuring 6.5 cm in circumference was noted…’. This emphasises the need, as pointed out in the letter, to visually inspect all products supplied before use to ensure that nothing untoward has happened during transportation.

The sentence ‘The supplier was notified and all bottles of BSS from the same batch were recalled’ is not correct. There was no ‘product recall’ associated with this product as the tests reported above showed no other defects. The hospital voluntarily exchanged all other units of this lot number held by them, and were provided with replacement units with a different lot number the next day.

We would appreciate your help in ensuring that this information is brought to the attention of your readers.