fda holds online glasses purchases.

[bob_f_aboc]

The issue also appears to be a massive failure of lenses that meet Z80.1 impact standards. Either ground too thin -or- bad plastic. I'm guessing the latter, knowing China's penchant for cutting corners, not using quality control, and then falsifying mandated certifications when push comes to shove.

38% drop ball test failure in one batch, 100% in another. That's bad plastic.

The pair I ordered from Coastal came in as poly with a 0.7 mm CT (the lenses actually flex when cleaning). The power was good, as long as you measure 1+mm away from the OC. I'm not surprised that they are failing impact testing.

[cocoisland58]

(the lenses actually flex when cleaning).

I have seen these, showed the patient "Look at that!"

[Chris Ryser]

The pair I ordered from Coastal came in as poly with a 0.7 mm CT (the lenses actually flex when cleaning). The power was good, as long as you measure 1+mm away from the OC. I'm not surprised that they are failing impact testing.

Made in Canada................there is no minimum thickness required on lenses like in the USA.

[MikeAurelius]

Good job on your posts over on the Coastal FB page, Mike!

B

Thanks Barry.

[MikeAurelius]

Made in Canada................there is no minimum thickness required on lenses like in the USA.

Unlikely. Made in China with a complete disregard of Z80.1.

And even if they were made in Canada, they STILL have to pass Z80.1 in order to be legally imported into the US.

[RT]

And even if they were made in Canada, they STILL have to pass Z80.1 in order to be legally imported into the US.

Z80.1 is a voluntary standard and has no standing with either FDA or US Customs. They have to pass 21 CFR 801.410, which specifies impact resistance requirements. Interestingly, neither FDA nor Customs cares about power tolerance, prism tolerance, etc., during importation. As noted in the FDA Import Alert:

*** Eyeglasses and sunglasses imported into the United States are required to comply with 21 CFR 801.410, "Use of impact-resistant lenses in eyeglasses and sunglasses". A certificate to comply with 21 CFR 801.410(g) must accompany each entry of eyeglasses and sunglasses showing the lens manufacturer has conducted tests of the lenses using the impact test described in paragraph (d)(2) of 21 CFR 801.410 or any equal or superior test. ***


Your point is still valid...it doesn't matter where they are made, to legally import into the US, the manufacturer and importer must follow US regulations. These include impact resistance and payment of any applicable duties. Foreign entities who are mailing spectacles directly to the consumer are in many cases bypassing those legal requirements.

You may remember the study published last year by AOA/TVC/OLA which examined safety and quality of online eyewear from a number of sources, with similar results of a large number of failures.

http://www.ncbi.nlm.nih.gov/pubmed/21871395

[MikeAurelius]

Yes, however, the method of testing is called out in Z80.1

[coupe]

I am curious. What are the required lens thicknesses in the USA. Here is Canada, everyone tries to make every lens ultra thin. And in my whole career, a long time, I have never drop ball tested a lens. So, if it must be done on a cut and finished lens...let's say it passes the DB test. Will the impact on the not affect the surface IE: AR coating, leave a dent, cause scratching. Very curious about that.

[MikeAurelius]

There is no "minimum thickness" per se, the lens has to pass the drop ball test. Safety jobs (I think) are the only ones that have a minimum thickness requirement.

[Browman]

Z80.1 is a voluntary standard and has no standing with either FDA or US Customs. They have to pass 21 CFR 801.410, which specifies impact resistance requirements. Interestingly, neither FDA nor Customs cares about power tolerance, prism tolerance, etc., during importation. As noted in the FDA Import Alert:

*** Eyeglasses and sunglasses imported into the United States are required to comply with 21 CFR 801.410, "Use of impact-resistant lenses in eyeglasses and sunglasses". A certificate to comply with 21 CFR 801.410(g) must accompany each entry of eyeglasses and sunglasses showing the lens manufacturer has conducted tests of the lenses using the impact test described in paragraph (d)(2) of 21 CFR 801.410 or any equal or superior test. ***


Your point is still valid...it doesn't matter where they are made, to legally import into the US, the manufacturer and importer must follow US regulations. These include impact resistance and payment of any applicable duties. Foreign entities who are mailing spectacles directly to the consumer are in many cases bypassing those legal requirements.

You may remember the study published last year by AOA/TVC/OLA which examined safety and quality of online eyewear from a number of sources, with similar results of a large number of failures.

http://www.ncbi.nlm.nih.gov/pubmed/21871395

A more valuable study would be one which specifically noted which websites were ordered from and the specific failure rates/categories of each. Generally stating "the ten most popular" and neglecting any further specifics lends a certain invalidity to the study.

[Tallboy]

A fantastic new hire we have, she showed me a couple of her coastal glasses she bought/got for free today, both with a "high index" upgrade, no mention of poly in the upgrade, are absolutely positively poly. FWIW.

I edged some "junk" old VSP patient's progressive lenses from the lab in the frame, progressive 1.67 with AR, and threw them in the donation box. Feels good man.

[Chris Ryser]

Unlikely. Made in China with a complete disregard of Z80.1.
And even if they were made in Canada, they STILL have to pass Z80.1 in order to be legally imported into the US.

Z80/1 is not a law in the USA..................it is a recommendation................. and volontary on top of that, as RT has explained

The use of American National Standards is completely voluntary; their
existence does not in any respect preclude anyone,whether he has approved
the standards or not, from manufacturing, marketing, purchasing, or using
products, processes, or procedures not conforming to the standards.
The American National Standards Institute does not develop standards and
will in no circumstances give an interpretation of any American National
Standard. Moreover, no person shall have the right or authority to issue an
interpretation of an American National Standard in the name of the American
National Standards Institute. Requests for interpretations should be
addressed to the secretariat or sponsor whose name appears on the title
page of this standard.

http://www.nfos.org/files/ANSIZ8012005.pdf

[MikeAurelius]

*sigh* Yes, Chris, I **KNOW** that, it was a typo. However, as I noted earlier in this thread (did you miss it?), Z80.1 calls out the specific test methods of drop ball impact testing, as well as permissible alternatives, AND spells out the types of lenses that are exempted from any drop ball testing. I personally consider the two "documents" (Z80 and the CFR regulations) to work hand-in-hand with each other.

I am not aware of any OD, optician, or dispenser in the United States (or Canada for that matter) who would accept a pair of spectacles made outside of the standards called forth in Z80, and to me, that gives them the "force of law". Whether or not you disagree with me doesn't matter, if the spectacles don't meet Z80, the OD, optician, or dispenser will reject them to be remade, and no court in the land would force them to be dispensed, hence a "defacto law".

[Barry Santini]

Z80 is as outmoded a standard in this day and age as dial-up internet access, IMHO.

B

[MikeAurelius]

I don't disagree, Barry, however, there really does have to be some sort of unified standard that the labs and OD, opticians, dispensers can all fall back on when there are issues. So far, all we have is Z80 and Z87. The European DIN standards most likely won't ever be applied here (not invented here syndrome) mainly due to the perceived "power" of ANSI.

[MikeAurelius]

I remember back when the ISO 9000 standards came out. One very wise man told me that the ISO 9000 standards have NOTHING to do with quality, it is all about documentation. If you made crap and install ISO 9000, you will still make crap, but it will be well-documented crap.

[Barry Santini]

I don't disagree, Barry, however, there really does have to be some sort of unified standard that the labs and OD, opticians, dispensers can all fall back on when there are issues. So far, all we have is Z80 and Z87. The European DIN standards most likely won't ever be applied here (not invented here syndrome) mainly due to the perceived "power" of ANSI.

Agree with you, Mike. But ECPs and the VC are ever increasingly hanging their public "scare-tactic" hat on ANSI/FDA compliance regarding online eyewear that *mplies* client satisfaction and efficacy are intimately tied-up in just compliance.

Any truly advanced ECPs knows better regarding the multi-layered aspect of eyewear satisfaction. And yes, price is inversely related.

And ANSI/FDA is completely divorced from the "delta"... the Rx or perceptual change that can and does upset so much of the public's vision applecart.

B

[theGross1]

"if the FDA doesn't want us to have affordable glasses, then they should pay for us to get them in a store".

~actual post on coastal facebook

"your glasses shattered and got in my eye so I'm suing the FDA for allowing this to happen"
~future coastal facebook post

[becc971]

"if the FDA doesn't want us to have affordable glasses, then they should pay for us to get them in a store".

~actual post on coastal facebook

"your glasses shattered and got in my eye so I'm suing the FDA for allowing this to happen"
~future coastal facebook post

truest story ever

[Chris Ryser]

Interesting................................... ------------------> http://www.fatwallet.com/Coastal-coupons/reviews/

[bob_f_aboc]

I chatted with their online customer service yesterday regarding the quality of the product they sent me and to ask if it had anything to do with the FDA holding their shipments.

The rep told me that the FDA is NOT holding Coastal's shipments, but are actually targeting FedEx due to the shipper's non-compliance with Federal regulations.

uh-huh...sure

[Johns]

I chatted with their online customer service yesterday regarding the quality of the product...

What a coincidence! I was just chatting with a state park attendant as to the cleanliness of the pit toilets at picnic area. He assured me they clean the toilets faithfully at the end of each season!

[Chris Ryser]

The rep told me that the FDA is NOT holding Coastal's shipments, but are actually targeting FedEx due to the shipper's non-compliance with Federal regulations.

They have done that forever in other areas. About 10 years ago when in Florida for the winter I ordered some of my medical prescriptions from my drugstore in Montreal te be sent by Fedex and it got held up by the FDA in Memphis the central turnstyle. I finally got them to return them to the sender, who put it in the mail and I got them a week later.

Another time a friend drove them over the border and put them on UPS 30 miles away.

Coastal will just change their ways to conform to the rules and be back by improving what is lacking. We all have to learn sometimes, and to comply with the rules should be no big job.

[MikeAurelius]

I chatted with their online customer service yesterday regarding the quality of the product they sent me and to ask if it had anything to do with the FDA holding their shipments.

The rep told me that the FDA is NOT holding Coastal's shipments, but are actually targeting FedEx due to the shipper's non-compliance with Federal regulations.

uh-huh...sure

Repeat the lie enough times and it becomes the truth.

[Wes]

Repeat the lie enough times and it becomes the truth.

Hey, it's what politicians do.