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Ophthalmology academy joins fight against contact lens deregulation

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WASHINGTON – The American Academy of Ophthalmology said it is fighting for patient eye safety, speaking out against recent moves in Congress and by the U.S. Food and Drug Administration.

The AAO has warned the FDA of serious health risks that would result from the FDA’s proposed plan to reclassify plano tinted contact lenses as cosmetic devices rather than medical devices. The AAO expressed that the deregulation of these colored contact lenses that do not correct vision could lead to improperly manufactured or poorly fitted contact lenses that can cause serious eye problems from corneal abrasions to complete loss of vision.

This opposition to the FDA’s plan echoes opposition also expressed by the American Optometric Association. The AOA expressed to Tommy Thompson, secretary of the U.S. Department of Health and Human Services, that this action raises serious health concerns.

In a letter to Sec. Thompson, J. Pat Cummings, OD, AOA president, said, "the very real health considerations associated with improper fit and wearing of lenses apply equally to both non-corrective and corrective power lenses. On behalf of the nation's 30,000+ doctors of optometry and their patients, we urge your immediate intervention to prevent implementation of this ill-founded proposal."

In an effort to preempt the FDA decision, which is expected to be announced soon, the AAO is working with its members to consolidate case studies to share with the FDA, illustrating the problems eye care practitioners have seen in patients, primarily teenagers, who have used these nonprescription, colored lenses.

In another matter, Congress has introduced an act that would mandate that patients receive a copy of their contact lens prescription (Contact Lens Prescription Release Act of 2002). The AAO warns that abusive situations could lead to a disregard of prescription validity.

In meetings with congressional representatives, the AAO argued that allowing third parties to fill unverified contact lens prescriptions significantly increases the risk of corneal damage and potential blindness.

"The Academy is extremely concerned about the impact on patients that these recent moves in Congress and at the FDA will have," said Catherine Cohen, AAO vice president for governmental affairs. "These are not decisions based on medicine, but on business and legal pressures, and Congress needs to focus on patient safety."