Classification of ophthalmic lenses ?

[Homer]

Jo said this under the "optometric Physicians" thread:
We are viewing eyewear as being analogous to a medication. Ophthalmic lenses are a Class I Medical Device.


"Examples of Class I devices include elastic bandages, examination gloves, and hand-held surgical instruments. Examples of Class II devices include powered wheelchairs, infusion pumps, and surgical drapes. Examples of Class III devices which currently require a premarket notification include implantable pacemaker pulse generators and endosseous implants.
http://www.fda.gov/cdrh/devadvice/3132.html


So, if ophthalmic lenses are not analogous to a medication and are more like elastic bandages and examination gloves, why do they require a "prescription" rather than a kind of work order?

[Chris Ryser]

Homer said:
Jo said this under the "optometric Physicians" thread:
We are viewing eyewear as being analogous to a medication. Ophthalmic lenses are a Class I Medical Device.


"Examples of Class I devices include elastic bandages, examination gloves, and hand-held surgical instruments. Examples of Class II devices include powered wheelchairs, infusion pumps, and surgical drapes. Examples of Class III devices which currently require a premarket notification include implantable pacemaker pulse generators and endosseous implants.
http://www.fda.gov/cdrh/devadvice/3132.html


So, if ophthalmic lenses are not analogous to a medication and are more like elastic bandages and examination gloves, why do they require a "prescription" rather than a kind of work order?

Did you know that materials for lens treatments, as for example,
hard coat materials, UV solutions, lens dyes and anythiung elses is classified by the FDA as a device and should individually be registered with the FDA?

Most of the suppliers of these products mark on their labels "for industrial use only" and therefore get away from being bothered by the FDA and forced to register.

Any addition to a frame or a lens becomes and is a device. Therefore by law none of these products should be used unless the company manufacturing or distributing them is registered with the FDA and therfore obliged to sell a device, that is providing the actual protection the manufacturer claims. Every foreign manufactrere of devices has products passed and inspected through FDA at the point of import into the USA.

[Homer]

Chris Ryser said:
Did you know that materials for lens treatments, as for example,
hard coat materials, UV solutions, lens dyes and anythiung elses is classified by the FDA as a device and should individually be registered with the FDA?

Are you saying that the manufacturer of the products must register them with the FDA or that the end user must register them?

I appreciate the information but how would this effect the need for ophthalmic lenses to be a "crontrolled substance" which would require a "dispense by prescription only" designation?

[RGV Optical Lab]

I would want a prescription for a pair of glasses to be verified with a prescription. Otherwise said customer could go out with a wrong prescription and get in an accident that he/she could probably pin on me since I made the glasses.

They are called "corrective lenses" because they should be correcting a medical condition (myopia, etc.), and they require a doctor to prescribe for the same reason. Readers at Wal-Mart or Walgreens don't require one because the are made for reading and do not require a prescription.