The American Optometric Association (AOA) recently sent a letter to the FDA requesting the prompt recall of 1-800 Contacts’ online eye exam, ExpressExam, which is marketed to the public as a way to renew contact lens prescriptions online without an in-person exam or fitting.
In the letter, the AOA mentions the recent recall of Visibly’s (formerly Opternative) online eye exam as an example of a similar device that has not yet received the proper authorization for marketing. The FDA had sent a warning letter to Opternative indicating that the device was both adulterated and misbranded, and it directed that Opternative immediately cease commercial distribution of the device.
AOA President Barbara L. Horn, OD, believes that 1-800 Contacts appears neither to have applied for premarket clearance for ExpressExam, nor met the standard of being substantially equivalent as a legally marketed visual acuity test.1
The AOA states in the letter that the device’s self-administered nature poses undue risks to consumers, such as inaccurate prescriptions, misfit contact lenses and the potential for misdiagnoses of serious eye conditions.
According to Dr. Horn, the 1-800 Contacts service does not provide any assessment for systemic diseases, such as diabetes or hypertension, which have potential ophthalmic manifestations. The letter also notes that, while users of the online exam receive a prescription for the contact lens that they previously wore, they will also receive a prescription for 1-800 Contacts’ own brand of AquaSoft contact lenses without a check for proper fit.
“I would note that, in the AOA’s evaluation of the 1-800 Contacts device, we found that the power listed on each prescription was the same, but the base curve varied,” Dr. Horn states. “This fact raises potentially serious issues because the AquaSoft contact lenses may not fit properly and are likely not to be checked for fit by an eye doctor.”
“ExpressExam was developed with leading ophthalmologists and is different from Visibly,” a spokesperson for 1-800 Contacts said in a recent email response to Vision Monday.1 “Our service enables a board-certified eye doctor to determine whether a customer's current prescription is working well and can be renewed.”
The spokesperson also noted that the company is currently working with the FDA on ExpressExam’s regulatory status.
|1. Vision Monday Staff. AOA letter to FDA requests a recall of 1-800 Contacts’ online vision test. Vision Monday. www.visionmonday.com/latest-news/article/aoa-letter-to-fda-requests-a-recall-of-1800-contacts-online-vision-test/. October 4, 2019. Accessed October 4, 2019.|