Email a Friend
Print Article
FDA to Explore Hazards of Contact Lenses
Less than two months after the FDA conducted public hearings regarding LASIK laser refractive surgery, the agency now wants to reconvene and explore another vital patient safety issue: contact lenses.
FDA's Ophthalmic Devices Panel originally spent a full day listening to dissatisfied postop patients and expert LASIK surgeons. The panel has announced several recommendations for consideration by the FDA.
For the past two years contact lens wearers have had a worrisome time. First there was an outbreak of a dangerous corneal infection caused by Acanthamoeba species. Corneal ulcers caused by Acanthamoeba are very difficult to treat and can lead to loss of the entire eye. The problem was first reported in Chicago but similar outbreaks were reported in other cities as well. Several months later there was a worldwide product recall regarding a specific brand of contact lens solution that was associated with many (not all) of the Acanthamoeba infections.
FDA will convene the Ophthalmic Devices Panel on June 10 to discuss general issues with various lens cleaners and whether new testing or package labeling should be required, according to a notice posted on the agency's Web site.
FDA will discuss developing testing methods to investigate the efficacy of multipurpose contact lens solution under "real-world" conditions. During the Acanthamoeba outbreak, some physicians suggested that the agency hadn't thoroughly tested the contact lens solutions under the conditions in which many patients actually use them.
Others have theorized that unclean water played a role in the outbreak. The timing of the Chicago outbreak coincided with changes in the city's water filtration system. Earlier outbreaks in Iowa and in Britain were linked to flooding and rooftop cisterns, respectively. FDA is also considering water sterilization data collected by the Centers for Disease Control and Prevention.
The information FDA collected from patients during the Acanthamoeba outbreaks suggests that many don't know how to properly clean their contact lenses. Patients have gotten so comfortable with contact lenses that they don't clean them properly and don't read package labeling.
As a reminder, be sure to remove your contact lenses before swimming, before participating in water sports, using hot tubs, and even before showering. Contact lens wearers also need to remember to always "rub and rinse" lenses before storage to safely remove germs.
Adapted from a news release issued by the American Academy of Ophthalmology.
Related Topics: <Technorati Tags: contact lens, FDA, corneal infections, Acanthamoeba, vision, eye health
FDA's Ophthalmic Devices Panel originally spent a full day listening to dissatisfied postop patients and expert LASIK surgeons. The panel has announced several recommendations for consideration by the FDA.
For the past two years contact lens wearers have had a worrisome time. First there was an outbreak of a dangerous corneal infection caused by Acanthamoeba species. Corneal ulcers caused by Acanthamoeba are very difficult to treat and can lead to loss of the entire eye. The problem was first reported in Chicago but similar outbreaks were reported in other cities as well. Several months later there was a worldwide product recall regarding a specific brand of contact lens solution that was associated with many (not all) of the Acanthamoeba infections.
FDA will convene the Ophthalmic Devices Panel on June 10 to discuss general issues with various lens cleaners and whether new testing or package labeling should be required, according to a notice posted on the agency's Web site.
FDA will discuss developing testing methods to investigate the efficacy of multipurpose contact lens solution under "real-world" conditions. During the Acanthamoeba outbreak, some physicians suggested that the agency hadn't thoroughly tested the contact lens solutions under the conditions in which many patients actually use them.
Others have theorized that unclean water played a role in the outbreak. The timing of the Chicago outbreak coincided with changes in the city's water filtration system. Earlier outbreaks in Iowa and in Britain were linked to flooding and rooftop cisterns, respectively. FDA is also considering water sterilization data collected by the Centers for Disease Control and Prevention.
The information FDA collected from patients during the Acanthamoeba outbreaks suggests that many don't know how to properly clean their contact lenses. Patients have gotten so comfortable with contact lenses that they don't clean them properly and don't read package labeling.
As a reminder, be sure to remove your contact lenses before swimming, before participating in water sports, using hot tubs, and even before showering. Contact lens wearers also need to remember to always "rub and rinse" lenses before storage to safely remove germs.
Adapted from a news release issued by the American Academy of Ophthalmology.
Related Topics: <Technorati Tags: contact lens, FDA, corneal infections, Acanthamoeba, vision, eye health
