Regulations in 85% of countries around the world explicitly require that consumers provide legal vision correction prescriptions when buy prescription glasses online, which stems from the logic of classification management of medical devices. According to Annex VIII of the EU’s Medical Device Regulation (MDR), single-light prescription lenses are classified as risk Class I devices, and it is mandatory for users over 16 years old to submit an optometry report from the past two years. In 2023, the US FDA’s warning letter to the e-commerce platform Glassesshop revealed that among the 2,000 randomly inspected orders, 12% were not signed and verified by optometrists, resulting in lenses with potential optical center errors exceeding the standard entering the market. Article 35 of the “Regulations on the Supervision and Administration of Medical Devices” of China further includes optometry and spectacle fitting under the management of Class II medical devices. Those who sell without a prescription may face a fine of 5 to 10 times the value of the goods.
There are significant regional differences in the prescription verification process. Data from the National Health Service (NHS) in the UK shows that the compliance rate of prescriptions on the GOS optometry certificate online verification system can reach 98%. However, in the US, due to the division of state management – for instance, Florida requires a prescription validity period of 24 months, while California only limits it to 12 months – 13% of cross-border orders have been cancelled due to validity period disputes. The operation report of Japanese eyewear chain JINS indicates that in 2023, approximately 8.5% of online prescriptions were triggered by manual review due to the lack of axial (astigmatism Angle) or pupillary distance data, with an average delay of 36 hours in shipment. There are exceptions for low-degree corrective products such as reading glasses: The EU allows the sale of finished reading glasses with a prescription of +3.00D or less, and such products account for 75% of the prescription orders on the German e-commerce platform Mister Spex.
The technical means that bypass prescriptions in the grey market bring health risks. Amazon’s third-party seller audit shows that the global sales of prescription lens options for regular lenses claiming to be “prescription free” reached 230 million US dollars in 2022, among which 40% of the orders were confirmed to have not been tested for optometry. The Indian Medical Research Council (ICMR) has tested and found that the probability of refractive power deviation of such lenses being ≥0.50D is 34%, and long-term use may accelerate the progression rate of myopia by 15%. More concealed is the risk of AI optometry applications: for instance, the calibration deviation of the vision testing APP EyeQue can reach ±0.25D, and the Norwegian Consumer Council has disclosed that its correlation coefficient with the results of physical optometry is only 0.63.
Facilitating the acquisition of prescriptions has become the key to breaking the deadlock. Warby Parker, a well-known e-commerce company in the United States, is connected to 8,000 brick-and-mortar stores and enables online users to complete electronic verification by optometrists within 72 hours after uploading prescription images (with an accuracy rate of 99.2%). The OptiExpert system developed by Essilor in France enables users with old lenses to upload photos of the lens parameters. Through polarized light analysis technology, prescriptions can be reverse-derived, with an error controlled within ±0.12D. In 2024, Boots Opticians in the UK implemented blockchain-based prescription evidence storage, which increased the efficiency of authorized access to optometry data by 40%. However, for first-time glasses fitting, the American Optometry Association (AOA) still emphasizes the necessity of a comprehensive physical examination – online prescription issuance cannot detect diseases such as glaucoma, and its early missed diagnosis rate can be three times that of physical examinations.
Consumer decisions need to balance convenience and risk. According to a survey by Statista, approximately 80% of prescription-free orders are for spare or decorative lenses with a prescription value of less than 20. Meanwhile, the proportion of users who insist on professional prescriptions for high refractive correction (>±6.00D) is as high as 9,550. However, ophthalmologists warn that the probability of visual fatigue caused by incorrect lenses increases by 70%, and the average annual productivity loss due to this is $1,200.