Legality of non-standard thickness glass..

[Optician]

Please note that this question is completely hypothetical in nature. ;)

Suppose an Optician were to be approached by a patient with a relatively high degree of myopia.

Further suppose that the patient had managed to purchase (and is presently wearing) 1.8 index glass lenses that had been ground to a CT of 1.2mm, and was unwilling to accept anything else.

While such lenses are illegal to produce in the United States (given the FDA regulations requiring glass lenses to be at least 2.2mm thick), what if the Optician were able to procure lenses from a country where there are no such limiting standards?

Namely, is it illegal to dispense a pair of eyeglass lenses manufactured to the above parameters- or is it merely illegal to manufacture such a product (or, is it legal to both manufacture and dispense the lenses given certain circumstances, upon notification to the patient)?

Hypothetically speaking, I would appreciate your collective input.
:)

[Blake]

If you dispense it, you assume a legal responsibility (I believe the term is fiduciary). So if something were to happen to the patient, you could be held liable for dispensing eyewear that didn't meet safety requirements.
If the patient wants those lenses, s/he'll just have to take a trip overseas.

[Ray Parent]

I was under the impression that all you needed was a waiver. While I don't have any direct experience with this, I have heard that some of the US based labs that handle Zeiss will produce those lenses.

[Jim G]

I believe that Zeiss Canada will produce the product and will also provide a waiver for the patient to sign. HOWEVER, position papers published by the Optical Laboratory Association OLA) clearly state that even with the waiver, dispensing such lenses in the US is probably illegal.

[John R]

Ray Parent said:
I have heard that some of the US based labs that handle Zeiss will produce those lenses.

I think you will find that Ziess lenses made state side will not be 1.2 thick..They will be thick enough to withstand the dropball test, which kinda defeats the object of higher index glass lenses

[Wes Trayner]

The FDA in 21 CFR 801.410 does not say anything about thickness. It states that the lens must pass the drop ball test. Actually all lens materials need to be tested in batches with records kept for the FDA to see. Most labs grind their glass lenses to a 1.9mm to 2.2mm thickness to insure passing the drop ball test. Corning's PGX Thin and Dark glass lenses pass the test at 1.5mm if they are chem tempered.

By the way, some courts have viewed waivers as an admission that you knowingly dispensed an unsafe medical device. There is language in 21 CFR 801.410 that states an ophthalmologist or optometrist may, by showing that the patients vision cannot be corrected with a lens that is drop ball tested, waive the requirement. I think this would leave one open for a suit if for some reason the patients lens broke ond injured him or her anyway.

[shanbaum]

With a few exceptions, glass lenses must be individually tested - no batch sampling allowed.

The question suggests that it is the manufacture of non-impact-resistant lenses that's prohibited, and I would take issue with that. I think that a U.S. firm could manufacture non-impact-resistant lenses for delivery outside the U.S.

Wes' point is well-taken, however; given the ubiquity of eager personal injury lawyers in the U.S., it would be slightly mad to find that "impact-resistant lenses will not fulfill the visual requirements for a particular patient." Under what circumstances could that finding be made?

I think that provision was a bone thrown to the practitioner community to parry the argument that the government had no business making "medical decisions". Some people are sensitive about that sort of thing.

[John R]

Just wonder why this law ? came about as in 27 years i have yet to see any personal injuries done by glass lenses (except my fingers)..:hammer: . I have seen injuries done by frames scraping the face during falls etc..
I mean how many pairs of glass lenses are worn daily..Is it just a case of someone covering their backside here....

[Pete Hanlin]

Yes, it probably is illegal to dispense the lenses described in Optician's post. I suppose the FDA has set legal limits on products out of a concern for our safety...

Doesn't it follow then, that we should also...

• Make tobacco, sugar, and food containing more than 50% of calories in the form of saturated fat illegal
• Place restrictors on all automobiles that limit speeds to the maximum speed limit allowed by law (or, better yet, install computerized restrictors that sense the local speed limit and limit the driver to that speed)
• Require every American citizen to perform aerobic excersizes four times a week for periods of 20 minutes or more
• Ban jet-skis, power boats, motorcycles, and every other form of recreational transport that could be replaced by safer forms of transportation
• Naturally, it goes without saying that we should also ban all guns, bows and arrows, slingshots and any other weapon that can be used to maim or kill

Point being, exactly where does the Constitution give the government the right to determine how safely individuals must live their lives? Where in the Bill of Rights is the proviso [i]"All the above shall be considered null and void if it is determined by state or federal legislation that such freedoms result in the potential for personal harm."??? Also, how far do we go in our quest to keep everyone safe? For example, statistics show that it is safer to fly across country than driving the same distance. Perhaps we should make it illegal to drive across country? Who gets to decide what level of personal risk I am allowed to take?

Sorry to side-track from a very good original question. I suppose the answer is "Yes, you can dispense the product the patient is asking for- just be sure to leave the lenses in the alley behind your office and have the patient leave payment in unmarked cash."
:angry:
What if the patient ordered the product directly from an overseas supplier? The FDA doesn't say it is illegal to purchase thin glass lenses, does it?

[John R]

Pete Hanlin said:
What if the patient ordered the product directly from an overseas supplier? The FDA doesn't say it is illegal to purchase thin glass lenses, does it?

Interesting point that one Pete, are you saying that you could test eyesite, then punter tells you he wants thin glass..but you cant do what he wants so you let them choose a frame you just take all the right measurements write them down for them and tell them to send them (with cheque) to XXX in England who will return them direct to them and if they need tweaking a bit then bring them back for proper fitting.... XXX then sends you $$$ commission for making a sale, would that be breaking the law... In sprit maybe...

Sound likes a good idea to me...

[shanbaum]

Pete Hanlin said: Point being, exactly where does the Constitution give the government the right to determine how safely individuals must live their lives?

"...in order to form a more perfect union, establish justice, insure domestic tranquility, provide for the common defense, PROMOTE THE GENERAL WELFARE, and secure the blessings of liberty to ourselves and our posterity..."

There.

Now, as far as what the law says about glass lenses, it simply says (in so many words) "lenses shall...". It doesn't speak directly about manufacture or delivery - other than to specify that imported products have to meet the same criteria. That's necessary, I think, because U.S. law would have no jurisdiction over foreign manufacturers, but it does have same over importers.

A company selling prescription eyewear into the U.S. from overseas would probably be considered to be in the business of importing them, so...

[Jeff Trail]

Waiver shmaivers, I can put it the way my corp. lawyer spelled it out for me after I showed him some samples of waivers from a few optician friends I have..both talking about 1.8 glass and dispensing non poly to someone under the age of 18.. his answer was "I would love to be the guy bringing the suit but not the poor schlep who has this as their main line of defense" ... not worth the paper it is printed on... EVEN if you had the patient sign it and explained it over and over.
WE as in WE the dispensers, should know the guidelines and regulations we are govern by and to knowingly dispense something that is NOT covered under our rules and regulations we are misusing our knowledge to gain profit from the uneducated public. (more his stuff than mine)
Ask the corp lawyers about it that work for L.C. and see how far you get if you are under 18 and want non poly? ..sure sign all the waivers you want, do cart wheels and backflips and pay for the cr39 lens.. but you are still going to walk out that door with either a poly or tri-vex material :-) They have what was it $7 or $8 million reasons they can give you why you are going to only get an impact resistant lens if you are under 18 :-)
I wouldn't do it and am not going to do it, you can print up any amount of "pretty" waivers for me to hand out, but that just will make the judges reading more enjoyable as you get the shiv from someone's lawyer...
No matter how much we complain and may not like it, we do have a set of laws and regulations we have to adhere to and NOT just to pick and choose from the ones we feel like following and the ones we want to ignore because I get to sell a $600 pair of PAL's.
"hypothetically" speaking, I'm covering my "hypothetical" a$$ and just doing what keeps me out of litigation as long as I can... and for you guys who think "oh well let them try it" I was sued once, it was thrown out, but still had to pay my lawyer around $6500 to do the leg work and represent me...that's just the system.
Me? I think it's not worth a small profit compared to the chances of losing everything. Waiver or not.

Jeff "shoulda went to law school instead of being in optics" Trail
pays way better :-)

[Steve Machol]

Well said Jeff! A waiver will not protect you should an injury occur. And in the final analysis, it's just not worth the risk.

[John R]

shanbaum said:

A company selling prescription eyewear into the U.S. from overseas would probably be considered to be in the business of importing them, so...

Ok, I can sort of see that, as if you didn't then your own manufactures would be disadvantaged..But hang on they are anyway on price grounds anyway...
What about someone that purchases a pair while out of the country then. How would that stand.

The daft part is while your country says it unsafe the rest of the world dosen't....
One word springs to mind here....minefield

[Pete Hanlin]

"...in order to form a more perfect union, establish justice, insure domestic tranquility, provide for the common defense, PROMOTE THE GENERAL WELFARE, and secure the blessings of liberty to ourselves and our posterity..."
Hmmm, the Supreme Court would be an interesting place if you and I were members (its already a fairly interesting place without our help)...

Although "general" can mean "each member," I believe it refers here to the "general" (as in "overall") welfare, not each person's individual welfare (which the framers of the Constitution made clear was each person's own business). Just my opinion, however.

PS- Perhaps I'd be a bit more understanding of the impact standards if I'd ever seen the result of a glass lens shattering into the eye... Any of you, um, "more experienced" Opticians out there seen a case involving a shattered glass lens?

PPS- I originally asked where in the Bill of Rights an exclusion was made for instances where personal injury could result... (in other words, where and when did the government decide it was our personal nanny?). I'm not saying all regulation is evil, just 99% of it (hey, I'm a Republican, remember)?

[John R]

Pete's thrown up a couple of points here on the safety aspect.
If a glass lens with a center substance of 1.2 m/m is considered unsafe as it might cause personal injury...How the hell can you justifiey selling guns.....As their main aim is to cause personal injury (read death)....

Yes i know personal rights and all that rubbish.. But if you use that arguement for guns then you can justifey glass lenses @1.2 m/m...

Just a brits view on your weird constuition.:cheers:

[shanbaum]

John R said:
If a glass lens with a center substance of 1.2 m/m is considered unsafe as it might cause personal injury...How the hell can you justifiey selling guns.....As their main aim is to cause personal injury (read death)....

You probably can't (though Dr. Johnson's epithet comes to mind - "a foolish consisency is the hobgoblin of little minds").

I wore Zeiss Lantals - glass, with a center thickness of a tad under 1.0mm - for over a year, until just recently. I loved them (what with my -9.00 Rx) but I do expect to burn in eternal hellfire as a result of having done so, thanks to my Canadian friend who provided them.

It's probably worth noting that the only method available to the FDA to enforce the impact resistance rule is to seek injunctive relief - that is, they have to go to court to stop you. It's not like they have an Rx lens police force.

The real power in the statute lies in setting the boundaries of good practice, and letting the tort system (the adjudication of injury claims) provide the enforcement, as has been noted.

I must say that I made a point of not wearing my thin glass specs when working with power tools or the like. I don't know what the statistics are regarding the number of lens-related eye injuries before and after the passage of that law. I'm sure they have declined, but then, the passage of that law coincided with the advent of the CR-39 era. Hmm... coincidence?

If there's something profoundly stupid about the law, it's that it requires a test that reduces the impact resistance of the lens - you'll rarely see a tempered glass lens (other than a very thick one) pass two drop-ball tests in a row.

[John R]

shanbaum said:
to my Canadian friend who provided them.

So you could legally get a pair from canada then? and what about south america?

If there's something profoundly stupid about the law, it's that it requires a test that reduces the impact resistance of the lens - you'll rarely see a tempered glass lens (other than a very thick one) pass two drop-ball tests in a row.

Yes does make you wonder about the sense of testing lenses, bit like holding a loaded gun to your head and pulling the trigger and saying yep that works OK for me...:hammer: :hammer:

[shanbaum]

John R said:

So you could legally get a pair from canada then? and what about south america?

Did I say I got them legally? Oh - have to go, there's a knock on the door...

[Darris Chambless]

Hello John,

Perhaps I can add a different perspective to your question.

"If a glass lens with a center substance of 1.2 m/m is considered unsafe as it might cause personal injury...How the hell can you justifiey selling guns.....As their main aim is to cause personal injury (read death)...."

Thin glass lenses are more prone to breakage if hit, but then again glass lenses in general are more prone to breakage as well because of the rigidity of the material and molecular makeup although less than a thin center glass lens. As Robert pointed out once you drop ball test a glass lens you have basically made it a "used" lens. This is motorcycle helmet terminology. A helmet worn by someone else and then sold to another is not consider "used" but rather a "used" helmet is one that has hit the pavement while on a persons head or has had some form of heavy impact. Then it is "used" and is less likely to protect you if ever in a situation where one has to depend on it even if it isn't broken. It's impact resistance is compromised. So dropball testing glass basically undoes what you did by heat or chem tempering anyway. Pretty silly in my opinion.

As to the gun arguement guns are not soley for personal injury or death. I shoot in competitons and no death occurs since paper targets and silhouettes don't breathe nor live. As to personal protection, I would much rather have a gun to go up against an assailent with a gun than a purse to beat them with ;) Actually I prefer knives for personal protection over pistols or rifles anyway, but I don't deminish the effectiveness of pistols or rifles.

Also one of the things I was taught in a safety and licensing class for handguns was that "for personal protection one usually only need show the gun to stop the aggresive behavior." One can at least argue the point that guns are products to be bought and sold and to outlaw them would be a violation of anti trust laws and the Sherman Act. To outlaw them would mean forcibly taking away the manufacturers livelihood which is illegal in the US because it is not a banned substance or product. In the hands of law abiding citizens that are trained to use them such as myself as well as a host of others they are of no danger at all, but you always have those fruitcakes out there that mess things up for everyone.

I always like the arguement that if we got rid of all the guns crime would decrease because criminals would not have guns. The unfortunate truth is that criminals don't aquire guns legally to begin with so those losing their gun owning priviledge would be the law abiding citizens that don't want to break the law by owning a prohibited product. Criminals don't really care about the law anyway hence the reason they're called criminals :) How does one justify the sale of guns? How does one justify the sale of 1.2 CT glass lenses? There is no justification for either. But the real question is how can one justify frivilous law suits? That is really the matter at hand and the reason for so much regulation.

Guns don't kill people. People kill people. Just like 1.2 CT glass lenses don't put peoples eyes out spontaneously. Flying objects that strike the lens do. Regulation in this day and time has gone straight to ludicrous :)

Darris C.

PS. People that illegally aquire thin glass lenses such as Robert should never be allowed to own a gun because he is a criminal :)

[John R]

Darris Chambless said:
People that illegally aquire thin glass lenses such as Robert should never be allowed to own a gun because he is a criminal :)

Hello Darris,
Mmm as usual a long reply.. ;)
I fail to see how Robert is a criminal as he was presented with the glasses as a gift from a friend in a country where they are legal ??? Or is possesion of a thin glass lens also against the law... In that case i think there will be quite a few US service persons who are in the doda.....
I understand your point about guns and all that, just seemed a good likeness to point out..:hammer:

[Jackie L]

As I recall...because we have adopted and use the ANSI safety standards in our profession, albeit voluntary, they are recognized as The standards in the eyes of the courts of law.

It is my understanding that not only will the lens manufacturer be sued, the O who dispensed the pair or the indiviual or business that fabricated the pair will be sued as well.

Hypothetically I would not touch it.

[Darris Chambless]

John R said:

Hello Darris,
Mmm as usual a long reply.. ;)
I fail to see how Robert is a criminal as he was presented with the glasses as a gift from a friend in a country where they are legal ??? Or is possesion of a thin glass lens also against the law... In that case i think there will be quite a few US service persons who are in the doda.....
I understand your point about guns and all that, just seemed a good likeness to point out..:hammer:

I just wouldn't want anything to get lost in the translation hence the reason my posts are long :) Now just for funzies lets say that I was given a gift by a friend. Lets say that gift was ten pounds of Cocaine. Now let's say that it was only for my personal use. Is it any less illegal? I'm just kidding Robert isn't really a criminal (that I'm aware of anyway) so if he wanted to buy a pistol or a rifle then I guess as long as he went through the propper channels i.e. paperwork in triplicate, full body cavity search, blood letting and so forth he should be allowed to purchase what he likes :)

I also know that you were aware of and understood what I was saying with regard to the gun issue, but I was making it look just as ludicrous the other way around. There isn't a person on the face of this planet that truly believes that guns walk around all by themselves and shoot people for no reason (although those that do believe this are usually heavily medicated and often times reside in institutions ;) Ignorance breads ignorance I always say.

I own a double action pistol 40 cal. and I'm proud of my purchase as well as quite accurate with it. If I were to have the pistol sitting in view and I had someone come in to my house and say "Oh my gosh! A gun! It could go off and hurt someone!" I would look them straight in the eyes and say "You don't know anything about guns do you?" and when they try to speak I would say "Unless you really want to look foolish I recommend you nod 'yes' quietly to the fact you know nothing about guns."

1.2 mm CT glass lenses are considered "illegal" because someones job depended on coming up with a new regulation :) These lenses are only illegal for the manufacturer if they get caught producing them and then they might only incur a fine unless someone files suit against them. Are they illegal to own? I don't know how that could be enforced even if they were illegal but I think it has more to do with liability than legality. Always remember: "Cop didn't see it. I didn't do it." :)

Well I gotta go for a bit. Take care and enjoy,

Darris C.

[Steve Machol]

As far as I know, simple possession of thin lenses is not a crime anywhere in the U.S. Of course, who's to say what they've made illegal in Texas! ;)

[John R]

Darris Chambless said:


I Lets say that gift was ten pounds of Cocaine. Now let's say that it was only for my personal use. Is it any less illegal?

Ah but that's illegal in the other country and the lenses are not.....

I think this is a no win situation we are in here... ;)

As they say "possession is 9/10 of the law" but 12/10 aint enough..... :hammer: