guest perspective
Contact Lens Adverse Event Reporting

When you hear the fire alarm, you quickly move to the nearest exit. We have been conditioned since kindergarten to do this because it may be a matter of life or death.

The fire alarm for contact lenses has sounded. Several organizations are now soliciting practitioners for information about contact lens-related complications. Unlike grade school students who learn about the fire bell, health providers may not learn about problem-reporting mechanisms at the outset of their professional education. They may have no knowledge or understanding of the system. They may not perceive any benefit to reporting medical device adverse events.

Contact lens adverse events may not be a matter of life or death, but they are an important public health matter. It would be very unfortunate if these events occur on a regular basis, but no one takes the time to report them. From a legal and regulatory standpoint, a scarcity of injury reports makes it difficult to form public health policy that effectively deals with concerns for contact lens-related problems. It's as if the alarm bell is ringing, but no one is responding.

Last fall, the FDA received more than 100 letters from organizations and individuals concerning plano contact lenses. Even without many cases in the database, the public health argument was convincing. The FDA has been and remains convinced that contact lenses present significant risks of blindness and other eye injury if distributed without the involvement of a qualified eyecare professional. The FDA emphasized this in its warning to consumers using decorative contact lenses that have not been prescribed and fit by a qualified eyecare professional. The FDA's MedWatch database subsequently recorded more than 10 reports of decorative/colored contact lens events since the warnings last fall. That may not seem like many, but it equals previous years' combined totals. You can report adverse events at http://www.accessdata.fda.gov/scripts/medwatch/ or at (800) FDA (332)-1088.

Last year in the 107th U.S. Congress, the Senate introduced the Contact Lens Prescription Release Act of 2002. It would have required the Federal Trade Commission (FTC) to promulgate a rule to establish requirements regarding the release of contact lens prescriptions. FTC held a public workshop in October 2002 on "Possible Anticompetitive Efforts to Restrict Competition on the Internet," where the sale of contact lenses was discussed. The driving force behind the discussion of legislation appeared to be consumers' economic welfare.

Without documentation of contact lens-related injuries, some believe it is difficult to make the case that a substantial public health risk exists. Eyecare practitioners must offer supporting documentation to frame the contact lens policy debate in terms of public health concerns. Your response may dictate the outcome. How will you respond to the bell?

This paper represents the professional opinion of the author and is not an official document, guidance or policy of the U.S. Government, the Department of Health and Human Services, or the FDA, nor should any official endorsement be inferred.

To receive references via fax, call (800) 239-4684 and request document #94.