In 2006, One Bottle of Lens Solution Disappeared from Shops Worldwide
In early 2006, eye clinics in Singapore and Hong Kong saw an unfamiliar rise. Fusarium fungal keratitis, uncommon in healthy eyes, was appearing one after another in contact lens wearers.
When cases were reported in the United States as well, the CDC and the FDA opened an investigation. A bottle of ordinary-looking care product found itself at the centre of a worldwide inquiry.
Looking for what the cases had in common
Investigators asked which lenses and which solution people used, whether they slept in their lenses, whether the lenses had been exposed to water, and when the bottle had been opened. Comparing cases with people who had not been infected, one answer kept coming back: Bausch + Lomb's ReNu with MoistureLoc.
In April 2006 the company halted shipments of product made at its US plant, and in May it permanently withdrew the product from markets worldwide. FDA records list every size and lot number, and put the distributed volume at roughly three million units.
How the solution types differ is set out in Why Is Contact-Lens Solution More Than Salt Water?.
Not simply a case of mould getting in at the factory
"Unopened product left the plant contaminated with fungus" did not explain everything. Fusarium was not consistently found in the investigated product or in factory testing.
The problem looked closer to an interaction between the product and how it was actually used. Over the weeks a bottle stays open the neck can become contaminated, the temperature can rise, and deposits can build up in the lens case. Habits such as topping off old solution with new, or not rubbing the lenses, were examined alongside it.
Disinfection performance does not have to work only in one clean laboratory scene. It has to work in a life that includes a bathroom shelf, a damp lens case, an open bottle and fingers.
Why such a large recall was needed
Fungal keratitis is uncommon, but it is difficult to treat. Ordinary antibiotics do not work on it as they stand, and a late diagnosis can leave corneal scarring or reduced vision.
When several countries see signals pointing to the same product, the cost of waiting is high. A recall is less a declaration that every bottle is contaminated than a step to stop exposure while the uncertainty lasts.
The episode also left questions about "no-rub" care. Today the CDC advises rubbing and rinsing lenses gently as the product directs, and storing them in fresh solution every time they are removed. Tap water is no substitute for lens solution.
The product, the lens, the case, your hands and how long you have used them form one care system. Use fresh solution and do not mix it with old, keep the bottle tip from touching your hands or the case, and if pain or a change in vision appears, take the lenses out and have your eyes checked.
A single small bottle withdrawn from the world showed that contact lens care is not a matter of the lens alone.
How to read a recall notice
The word "recall" is not a reason to throw out everything a company makes. Check the official notice for the exact product name, size, lot number, plant of manufacture and the regions where it was distributed. Equally, do not assume a similar name means your product is not the one.
If your product is covered, do not put new lenses back into that solution; follow the official return or disposal instructions. If something is wrong with your eye, do not stop at swapping products — tell the clinician which product you used and when the symptoms began. That rare infections only become visible when records from several hospitals and countries are joined together is another lesson from this episode.
Dates and how long a product lasts once opened are covered in Why Do Unopened Contact Lenses Have an Expiration Date?.
References
- FDA recall record, ReNu with MoistureLoc
- CDC, Fusarium Keratitis — Multiple States, 2006
- CDC, Cleaning, Disinfecting and Storing Contact Lenses
For the current safety status of any product, check the latest notices from regulators and the manufacturer.