FDA: FUSARIUM KERATITIS ADVISORY

April 12, 2006

Dear Contact Lens Patient,

You have no doubt read about the reported fungus infection induced keratitis with
the implication of increase incidence in soft contact lens wearers and the
disproportionate association with the use of ReNu soft lens cleaning and
disinfecting solution.

These are the facts:

Microbial keratitis is a severe infection of the cornea. Risk factors for infection
include trauma (generally with plant material), chronic ocular surface diseases,
immunodeficiency, and rarely, contact lens use. The annual incidence is 4-21 per
10,000 soft contact lens wearers depending on overnight use. Fungal keratitis is a
condition more prevalent in warm climates; in the southernmost United States,
fungal keratitis comprises up to 35% of microbial keratitis cases compared with 1%
in New York.

Of over 30 million soft contact lenses wears, there have been 109 reported cases of
suspected fungal keratitis in 17 different states. Although the majority of case
patients have yet to be interviewed, complete data are available for 30 of them.
Twenty-eight of the 30 wore soft contact lenses. Preliminary information obtained
by the Communicable Disease Center from patient interviews indicates that 26
reported using a Bausch & Lomb ReNu brand contact lens solution in the month
prior to the onset of infection. Patients reported using a variety of different ReNu
types from multiple different product lots. Five of the patients reported using other
solutions in addition to the ReNu product. Nine of the patients reported wearing
lenses overnight, a known risk factor for microbial keratitis. Eight required corneal
transplantation. Clusters of Fusarium keratitis were reported among contact lens
users in Asia beginning in February, 2006.

Although Bausch & Lomb has suspended shipment of their ReNu products, no
recall has been issued and per CDC and the FDA, no cause has been established.
Products from the lots of ReNu that were identified by patients in Singapore, Hong
Kong and the U.S. were tested and shown to be effective in killing both standard
strains and clinical isolates of the fungus.

What should you do as a soft contact lens wear?

1) As we have continuously instructed, wash your hands thoroughly before
handling your contacts lenses, before removing the lens from the case, inserting the
lens in your eye or removing the lens from your eye.

2) Rinse the lens with disinfecting solution and it would be a good idea to gently
rub the lens with the solution before soaking the lens overnight in fresh contact lens
multipurpose solution.

3) Use the proper products for cleaning and disinfecting your soft contact lenses.
Multipurpose solutions are indicated for lenses that are used for a maximum of one
months. Other soft contact lenses require alternate methods of care.

4) Clean the contact lens case daily. Change the contact lens case every 3-4
months.

5) Remember that saline solutions and rewetting drops are NOT designed to
disinfect lenses. You must use a cleaning and disinfecting solution.

6) If you feel more comfortable about using another cleaning and disinfecting
solution other than ReNu, we recommend Opti-Free brands of cleaners. We advice
that you not use generic, store brand products as these may also be made by Bausch
& Lomb.

7) If you should experience any discomfort in your eye, discontinue the contact
lens wear, use your glasses and contact our office.