The FDA and the CDC have issued an alert to health care professionals
and patients about a lense solution that can cause a rare eye infection
caused by a fungus, Fusarium. The infection is rare, but serious - and can cause permanent loss of vision.
The FDA reports that several patients have experienced significant loss of vision. Many have needed corneal transplants.
Investigators have identified the fungus as Fusarium. Since April 9, 109 cases of Fusarium Keratitis are being investigated by the CDC and authorities in 17 US states.
Dr. Daniel Schultz, FDA's Center for Devices and Radiological Health Director, said "This is a serious infection and soft contact lens users should be mindful of the potential to develop this problem. We're advising consumers to practice good basic hygiene and follow manufacturers' instructions for proper use, cleaning and storage of their lenses, and report any signs of infection to their doctors."
Authorities are advising clinicians who diagnose microbial keratitis to refer their patient to an ophthalmologist, if appropriate to obtain a specimen for lab analysis.
The FDA and CDC urgently advise contact lens users to make sure their soft lenses and products used to maintain them are not contaminated.
The following measures should be taken:
-- Wash your hands with soap and water (lint-free method) before touching the lenses
-- Replace your lenses according to the timetable given to you by your doctor
-- Carefully follow the instructions given to you by your doctor and manufacturer regarding cleaning and storage of the lenses
-- Replace your contact lense case every 3-6 months
-- Make sure you keep your contact lense case clean
-- If you experience redness, pain, tearing, increasing light sensitivity, blurry vision, discharge or swelling - remove the lenses immediately and see your doctor.
The FDA and CDC also advise wearers to perform a 'rub and rinse' lens cleaning method, instead of the 'no rub method'. This will minimize the number of germs and reduce the likelihood of infection.
So far, 30 patients have been investigated fully. 28 of them use soft contact lenses, two don't use any contact lens at all. 26 of those 28 soft lens users used Bausch & Lomb ReNu cleaning solution, or a generic brand made by the same company. Five of those 26 used other solutions as well as the ReNu brand. 9 of the patients kept the lenses on overnight (in their sleep).
Sleeping with your lenses on at night increases the risk of microbial keratitis.
Dr. Schultz added "It is important to note that some of the affected patients had used other solutions in addition to the ReNu brand, and that the source of this fungus has not yet been identified. But we're working with CDC and Bausch & Lomb -- and we're investigating other possible causes -- to prevent these infections."
Bausch and Lomb has voluntarily stopped shipping the ReNu Moisture Loc and are investigating the cause of the infections.
The FDA advises any soft contact lens wearer who has existing stocks of Renu Moisture Loc to use the product with caution and report any symptoms of eye infection immediately.
In February of this year Bausch & Lomb voluntarily suspended sales of its ReNu multipurpose solutions in Singapore and Hong Kong after several people reported eye infections.
The FDA reports that several patients have experienced significant loss of vision. Many have needed corneal transplants.
Investigators have identified the fungus as Fusarium. Since April 9, 109 cases of Fusarium Keratitis are being investigated by the CDC and authorities in 17 US states.
Dr. Daniel Schultz, FDA's Center for Devices and Radiological Health Director, said "This is a serious infection and soft contact lens users should be mindful of the potential to develop this problem. We're advising consumers to practice good basic hygiene and follow manufacturers' instructions for proper use, cleaning and storage of their lenses, and report any signs of infection to their doctors."
Authorities are advising clinicians who diagnose microbial keratitis to refer their patient to an ophthalmologist, if appropriate to obtain a specimen for lab analysis.
The FDA and CDC urgently advise contact lens users to make sure their soft lenses and products used to maintain them are not contaminated.
The following measures should be taken:
-- Wash your hands with soap and water (lint-free method) before touching the lenses
-- Replace your lenses according to the timetable given to you by your doctor
-- Carefully follow the instructions given to you by your doctor and manufacturer regarding cleaning and storage of the lenses
-- Replace your contact lense case every 3-6 months
-- Make sure you keep your contact lense case clean
-- If you experience redness, pain, tearing, increasing light sensitivity, blurry vision, discharge or swelling - remove the lenses immediately and see your doctor.
The FDA and CDC also advise wearers to perform a 'rub and rinse' lens cleaning method, instead of the 'no rub method'. This will minimize the number of germs and reduce the likelihood of infection.
So far, 30 patients have been investigated fully. 28 of them use soft contact lenses, two don't use any contact lens at all. 26 of those 28 soft lens users used Bausch & Lomb ReNu cleaning solution, or a generic brand made by the same company. Five of those 26 used other solutions as well as the ReNu brand. 9 of the patients kept the lenses on overnight (in their sleep).
Sleeping with your lenses on at night increases the risk of microbial keratitis.
Dr. Schultz added "It is important to note that some of the affected patients had used other solutions in addition to the ReNu brand, and that the source of this fungus has not yet been identified. But we're working with CDC and Bausch & Lomb -- and we're investigating other possible causes -- to prevent these infections."
Bausch and Lomb has voluntarily stopped shipping the ReNu Moisture Loc and are investigating the cause of the infections.
The FDA advises any soft contact lens wearer who has existing stocks of Renu Moisture Loc to use the product with caution and report any symptoms of eye infection immediately.
In February of this year Bausch & Lomb voluntarily suspended sales of its ReNu multipurpose solutions in Singapore and Hong Kong after several people reported eye infections.
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