June 15, 2007

Advisory: Serious Corneal Infection Risk Associated with Certain Soft Contact Lens "No-Rub" Cleaning Products

To all patients and friends of LA Sight,

The FDA and certain ophthalmology interest groups have asked all eye care professionals to circulate an advisory to their patients.  This pertains to a recent outbreak of very rare (fungal and amebic) corneal infections associated with certain contact lens cleaning solutions.

Corneal infection ( also referred to as “corneal ulcer” or "infectious keratitis") can lead to severe visual disability, and requires prompt treatment.  In severe cases, corneal scarring or even melting can result, and treatment may need to include a corneal transplant.  Contact lens wear is a known risk factor for infectious keratitis.  All types of contact lenses can cause or contribute to infection.

Extended wear soft lenses carry greater risk than daily wear hard or soft lenses.  Corneal changes from contact lens use include chemical stress (reduced Oxygen availability to the cornea), mechanical stress, and increased infection risk.  Contact lenses also can induce dry eye and reduce corneal sensitivity.  Overnight wear of rigid gas permeable ("RGP") lenses as used for orthokeratology (Ortho-K") has also been associated with bacterial keratitis.

Recently, some of the more heavily-marketed and "consumer friendly" contact lens solutions have been identified as playing a key role in the increase in incidence of rare but very serious infectious keratitis.  Specifically, Bausch & Lomb's ReNu with MoistureLoc solution has been linked to fungal infections (by a specific fungus called Fusarium).  This product was recalled from the US market in mid-2006.  More recently AMO's Complete MoisturePlus solution has also been recalled, due to an increased incidence of amebic keratitis (this organism is called Acanthamoeba).

If you are still using either of these lens care products, I strongly advise that you stop use immediately and change to another commercially available lens care product.

In addition, it may turn out that all "no-rub" solutions carry certain unacceptably increased risks for these rare infections.  I therefore suggest that if you wear contact lenses, you resume the practice of a separate cleaning step, rubbing the lens gently with a fingertip and then rinsing before placement in any overnight storage container .  Obviously, sensible use and cleaning of contact lens cases (or replacement of the case - they're cheap!) used for overnight storage is also smart.

In the general population of contact lens wearers, these infections are extremely rare - less than 1 in 500,000.  It is in everyone's best interest to keep all risk factors as low as possible where contact lens use is involved.  I hope this is helpful; it is not our intent to cause widespread panic or unreasonable fear about proper contact lens use.

In certain situations, soft contact lenses may be used in conjunction with laser vision correction treatment such as LASIK and PRK.  I am not aware of any undue risks associated with use of "band-aid contact lenses" in this context.

Further reading:

Bausch & Lomb Global Recall of ReNu with MoistureLoc Contact Lens Cleaning Solution http://www.fda.gov/bbs/topics/NEWS/2006/NEW01371.html

AMO Announces Voluntary Recall of Complete Moistureplus Multipurpose Solution http://www.fda.gov/oc/po/firmrecalls/amo05_07.html

If you have any questions, please contact my office.
    
Thank you kindly,

David A. Wallace, M.D.
LA Sight
11600 Wilshire Blvd., Suite 200
Los Angeles CA 90025
310 828-2020