Lasik Plus

Every year, the approach of Halloween heightens fears at the U.S. Food and Drug Administration (FDA) that consumers will harm their eyes with unapproved decorative contact lenses. These are contact lenses that some people use to temporarily change their eye color or to make their eyes look weird—for example, giving them an “eye-of-the-tiger” look.

“Although unauthorized use of decorative contact lenses is a concern year-round, Halloween is the time when people may be inclined to use them, perhaps as costume accessories,” says James Saviola, the Ophthalmic and Ear, Nose and Throat Devices network leader in FDA’s Center for Devices and Radiological Health.

The problem is not that people use decorative, non-corrective contact lenses. It’s that many go about it the wrong way, which is dangerous.
Prescription Required

Just like their corrective counterparts, decorative contact lenses—sometimes called plano, zero-powered, or non-corrective contact lenses—are regulated by FDA.

Recent legislation has made it illegal to market decorative contact lenses as over-the-counter products. Still, FDA is aware that consumers without valid prescriptions have bought decorative contact lenses from beauty salons, record stores, video stores, flea markets, convenience stores, beach shops, and the Internet.

“What troubles us is when they are bought and used without a valid prescription, without the involvement of a qualified eye care professional, or without appropriate follow-up care,” says Saviola. “This can lead to significant risks of eye injuries, including blindness.”

Unauthorized contact lenses of all types present risks to the eye that include corneal ulcers, corneal abrasion, vision impairment, and blindness.
If You Want Decorative Contacts

* Get an eye exam from a licensed eye care professional, even if you feel your vision is perfect.
* Get a valid prescription that includes the brand and lens dimensions.
* Buy the lenses from an eye care professional or from a vendor who requires that you provide prescription information for the lenses.
* Follow directions for cleaning, disinfecting, and wearing the lenses, and visit your eye care professional for follow-up eye exams.

Consumers should report any problems with decorative contact lenses to their local FDA Consumer Complaint Coordinator. Any adverse reactions experienced with the use of these products, and/or quality problems should also be reported to FDA’s MedWatch Program.

This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.

Updated: October 22, 2009

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Agency also Announces Warning Letters Issued to LASIK Facilities

The U.S. Food and Drug Administration today announced the launch of a collaborative study with the National Eye Institute and the U.S. Department of Defense to examine the potential impact on quality of life from Laser-Assisted In Situ Keratomileusis (LASIK), a surgical procedure that uses an eximer laser to permanently change the shape of the cornea.

The goal of the LASIK Quality of Life Collaboration Project is to determine the percentage of patients with significant quality of life problems after LASIK surgery and identify predictors of these problems.

Funded by the government agencies, the project is composed of three phases. The objective of Phase 1, which began in July 2009, is to design and implement a Web?based questionnaire to assess patient-reported outcomes and evaluate quality of life issues post-LASIK, some of which may relate to the safety of the lasers used in the LASIK procedure.

Phase 2 will evaluate the quality of life and satisfaction following LASIK as reported by patients in a select, active duty population treated at the Navy Refractive Surgery Center.

Phase 3 will be a national, multi-center clinical trial and will study the impact of the procedure on quality of life following LASIK in the general population. Patient enrollment in Phases 2 and 3 have yet to begin but plans are underway. Phase 3 is expected to end in 2012.

The results of the project will help identify factors that can affect quality of life following LASIK and potentially reduce the risk of adverse effects that can impact the surgical outcome. If any of these factors are related to the safety or effectiveness of the lasers used in LASIK surgery, the FDA will evaluate whether any action is necessary. The project is part of the FDA’s ongoing effort to better monitor and improve the safety and effectiveness of the lasers used in LASIK surgery.

“This study will enhance our understanding of the risks of LASIK and could lead to a reduction in patients who experience adverse effects from the procedure,” said Dr. Jeffrey Shuren, acting director of the FDA’s Center for Devices and Radiological Health.

The FDA also announced that it issued warning letters to 17 LASIK ambulatory surgical centers after inspections revealed inadequate adverse event reporting systems at all the centers. The inspections did not identify problems with the use of the LASIK devices at these facilities.

Under legislation passed in 1990, user facilities, which include nursing homes, outpatient clinics and ambulatory surgical centers, must report device-related deaths to the FDA and to the device manufacturer. They also must report device-related serious injuries to the manufacturer or to the FDA if the manufacturer is not known. Requirements include having a written protocol for adverse event reporting.

The FDA inspected ambulatory surgical facilities that perform LASIK over the past several months and additional inspections are pending. The FDA regulates ophthalmic lasers used in LASIK, including monitoring their continued safety and effectiveness by analyzing reports on their post-market use.

“Many people in the U.S. undergo LASIK procedures,” said Shuren. “Ambulatory surgical centers that perform LASIK must maintain a robust reporting system as required by law. Reporting adverse events to the FDA is critical to better understand the safety and effectiveness of ophthalmic lasers used in LASIK procedures and to enable the FDA to take appropriate actions where the lasers do not meet safety and effectiveness requirements.”
Media Inquiries: Peper Long, 301-796-4671, mary.long@fda.hhs.gov
Consumer Inquiries: 1-888-INFO-FDA

For more information:

The FDA’s Web site on LASIK:

http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/SurgeryandLifeSupport/LASIK/default.htm

FDA Guidance: Medical Device Reporting for User Facilities:

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM095266.pdf