This article is more than 5 years old. Information may no longer be current.
FDA warning for plano contacts applauded by ophthalmic industry
Lens manufacturers, however, have voiced concerns over potentially misleading wording.
Click Here to Manage Email Alerts
A federal warning regarding the dangers of noncorrective, decorative contact lenses without a prescription and without proper fitting by an eye care professional has won praise from the ophthalmic profession. While contact lens manufacturers support the warning, some have expressed concerns about its wording.
“Consumers should understand that decorative contact lenses, like contact lenses intended for correcting vision, present serious risks to eye health if they are distributed without a valid prescription and proper fitting by a qualified eye care professional,” said Lester M. Crawford, deputy commissioner of the Food and Drug Administration.
The FDA also issued an import alert instructing FDA and customs officials to automatically detain all decorative contact lenses presented at U.S. points of entry. According to this alert, the FDA will seize decorative contact lenses currently on the market in violation of federal law.
Similarly, the American Academy of Ophthalmology applauded the FDA’s warning against plano lenses obtained without a prescription.
“We think the FDA’s aggressive enforcement of federal law will have a significant impact on stemming the recent public health crisis presented by the sales of illegal costume contact lenses,” said Catherine Cohen, academy vice president for governmental affairs.
The AAO met with FDA officials and shared 15 case studies showing adverse effects experienced by patients who wore these lenses without the supervision of an eye care professional. Among these adverse effects were corneal ulcers and even blindness, Ms. Cohen said. The FDA filed a complaint, and planned to seize illegal products.
The FDA warning is a significant departure from recent discussions regarding the proposed deregulation of plano lenses. U.S. contact lens manufacturers, suppliers and professional organizations reacted strongly to a possible move to reclassify plano cosmetic contact lenses as “cosmetics” rather than medical devices. The American Optometric Association, along with several state senators, previously voiced their concern regarding the proposal.
“This warning is a 180° shift in position in a short amount of time,” said Michael D. Jones, OD, AOA executive director. “The AOA is delighted that the FDA is taking the proper stand in order to protect consumers, particularly teenage consumers, from the hazards of over-the-counter, nonprescriptive contact lenses.”
Dr. Jones added that he believes the FDA warning is likely to inhibit the sales of nonprescription plano lenses.
“This will at least cause the people selling these lenses to have second thoughts,” he said. “This can’t be a huge revenue-producer for them; it is just another thing they’re selling at the pawn shop. If they know the FDA is serious, it may seriously curtail, if not eliminate, the sales of these lenses.”
Confusion over wording
Although the warning was largely applauded by eye care professionals, its wording has reportedly caused concern among some in the industry.
The warning discussed the risks of permanent eye injury with the use of plano contact lenses obtained without a prescription. Although it pertained only to illegally distributed plano lenses, some manufacturers felt the warning might be seen as disparaging to all decorative lenses.
Although contact lens companies support the FDA’s warning, several lens manufacturers have spoken out to defend the legality and safety of their products.
“CIBA Vision wants to clarify that CIBA Vision brands of cosmetic and decorative lenses remain approved by the FDA and can be worn safely, if prescribed by a licensed eye care professional,” said Steve Osbaldeston, president of CIBA Vision North America.
According to Doug Brayer, cosmetic lens marketing manager for CooperVision, his company is entirely within legal regulations for plano lens distribution. He added that this fact has not been made clear in recent media coverage.
“CooperVision lenses are sold only through legal distribution channels,” Mr. Brayer said. “Unfortunately, several recent media accounts that focused on the illegal sale of novelty lenses failed to distinguish the proper distribution of our NFL Crazy Lenses from the occurrence of illegal sales.”
Phil Keefer, president of Vistakon Americas, expressed confidence in the regulations imposed by Vistakon on its cosmetic lenses.
“Such regulation, along with expert oversight by eye care professionals, has resulted in an excellent safety record for these products,” he said.
Ocular Sciences Inc., manufacturer of the Biomedics Colors disposable contact lens, has also spoken out in praise of the FDA warning.
“One of the founding principles of Ocular Sciences was that patients should always see a professional for any eye care need,” said Stephen J. Fanning, president and CEO. “We’ve been alarmed by the increasing level of injury suffered by patients who buy decorative lenses through sources other than eye care professionals, and we wholeheartedly support the FDA’s actions.”
A note from the editors:
This article was previously published in Primary Care Optometry News, a SLACK Incorporated publication.
For Your Information:
- Lester M. Crawford can be reached at the Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857; (888) 463-6332; fax: (800) FDA-0178.
- Steve Osbaldeston is president of CIBA Vision North America. He can be reached at CIBA Vision Corporate Communications, 11460 Johns Creek Parkway, Duluth, GA 30097; (678) 415-3937; fax: (678) 415-3416.
- Doug Brayer is cosmetic lens marketing manager for CooperVision. He can be reached at 200 Willow Brook Office Park, Fairport, NY 14450; (716) 264-3248; fax: (716) 264-3283.
- Phil Keefer is president of Vistakon Americas. He can be reached at 7596 Centurion Parkway, Jacksonville, FL 32256; (904) 443-1726; fax: (904) 443-1043.
- Stephen J. Fanning is president and CEO of Ocular Sciences Inc. He can be reached at 1855 Gateway Blvd., 7th Floor, Concord, CA 94520-3200; (800) 972-6724; fax: (650) 615-9702.
- Michael D. Jones, OD, is executive director of the American Optometric Association. He can be reached at 243 North Lindbergh Blvd., St. Louis, MO 63141; (314) 991-4100; fax: (314) 991-4101.
- Catherine Cohen is vice president for government affairs at the American Academy of Ophthalmology. She can be reached at PO Box 7424, San Francisco, CA 94120-7424; (415) 561-8500; fax: (415) 561-8533.