Article

CONTACT LENS DESIGN & MATERIALS

THE BROKEN STATE OF PASSIVE VERIFICATION

On occasion, I receive questions from Contact Lens Spectrum readers. When possible, I answer these questions directly; but, I felt that a recent inquiry may be of more general interest. Therefore, my column this month will be devoted to that topic.

A practitioner asked two questions:

1) How could a patient of his have been shipped contact lenses from an online supplier when the practitioner had never fit the patient with contact lenses?

2) Why could the practitioner not find a U.S. Food and Drug Administration (FDA) clearance for the contact lenses that were shipped when searching for those lenses on the FDA site?

Search for the Manufacturer

Let’s deal with the second question first. The lens supplied would be similar to a “private label” example. Therefore, a search for the clearance letter for that particular contact lens brand name will not be successful. You need to search for letters issued to the manufacturer of that lens, which should be listed on the contact lens label.

In this case, rather than a premarket application and clearance for a new product (which the practitioner could not find), the manufacturer submitted a 510(k) premarket notification asking for a determination of “substantial equivalence” to another cleared and legally marketed device. Once granted this determination, the manufacturer is then responsible for annual registration of the product, subject to all normal manufacturing standards. The manufacturer is also subject to inspection, abiding by labelling requirements, and meeting all medical device reporting guidelines for device-related adverse events.

Passive Verification Concerns

Now back to the first, slightly more complicated question. Under the Fairness to Contact Lens Consumers Act (FCLCA), a “seller may sell contact lenses only in accordance with a contact lens prescription” presented to the seller by the patient or verified by direct communication with the provider [FCLCA Sec. 4(a)].

Information found on this particular online seller’s website suggested that the seller generally attempted to receive verification over weekend hours. The practitioner in question did not think that a verification attempt had been made, but it is difficult to know for sure; staff may have missed or mistaken the recorded verification attempt. It also may not have occurred at all.

When there is no response to the verification attempt within eight business hours, the seller is allowed to supply the contact lenses based on what is generally referred to as “passive verification.” Again, a look at this particular seller’s website indicates that the company makes no attempt to have patients supply their contact lens prescription or even asks whether they have one. Consumers are simply asked to select the right eye and left eye spherical powers from a drop-down menu (which this patient took from her spectacle Rx). There is no way for consumers to list the name of their contact lenses, the manufacturer, the base curve, or the diameter, and there is no ability to include or attach this in any type of freeform note. Patients are informed that the contact lens prescription will be verified with their prescriber, yet the information collected is not sufficient to know for which contact lenses the patient may have a prescription.

This particular patient stated that she had seen YouTube videos of persons receiving contact lenses to try for the first time. A quick search easily returns a number of such videos. She also reported watching videos on lens application and removal. This would appear to give the impression to viewers that you do not require a contact lens prescription—you can just order and try them.

It’s a Matter of Patient Safety

This example would appear to be at the least a contravention of the spirit or intent of the FCLCA passive verification section, and it is quite possibly a violation of the law. As medical devices, contact lenses require a prescription from a provider, and we should continue to do all that we can to see that enforced. CLS