Why are foreign made glasses failing FDA tests for USA safety standards?
It is my understanding that polycarbonate lenses are produced under extremely high pressure and getting that just right is key to making a quality lens. So are the internet lens makers short-cutting a curing process or is it something else that has them breaking at up to a 40% when the FDA does random drop ball tests on these cheap glasses?
Anyone know?
If you are referring to the OLA test review, remember that they tested ALL the eyewear they received. We don't (plastics with stk AR are exempt).
B
Who says the lenses they are testing are poly? Cr39 is cheaper and doesn't require src coats like poly making Cr the preferred material for cheap specs. Cr will sure fail a dropball if processed too thin.
Foreign countries are not under US FDA regulations and can make and sell ultra thin lenses even in very brittle flint glass lenses.Originally Posted by Uncle Fester
It is easy to intercept these glasses at entry to the US and test them, and some fail, as well as some that are made in the USA, that would fail
if tested.
The preferred material for internet is a 1.55/1.56 derivative which are all very brittle even when molded and cured to pass FDA specs.
Right on. They don't need no stinking FDA or OSHA or FBI approval to manufacture glasses and ship them to the good old United States. If Elliot Ness and the Untouchables intercept sub-standard goods at the border it just tough toe nails for the customer. They just re-do the order and reship.
Perhaps importers should have mandatory labels that say........"Warning...this optical device only meets safety and or production standards in it's country of origin, which is _____________. To view those standard of safety and compliance contact www. etc.etc.
Eyes wide open
+1!!!!
Lost and confused in an optical wonderland!
Well, to be fair, the law DOES state that imports MUST meet the *US* impact standards. This is supposed to prevent unsafe products from entering the market. Looks to me like they are doing a good job (finally).Perhaps importers should have mandatory labels that say........"Warning...this optical device only meets safety and or production standards in it's country of origin, which is _____________. To view those standard of safety and compliance contact www. etc.etc.
Just curious. If the customs / FDA pulls a pair of finished eyeglasses out for testing, and during the drop ball test, they are damage, BUT PASS the test, what do they do. Lets say the test scratches the AR coating, who is responable. Do they just wrap things back up and send the damaged glasses to the client. Do they return them to the company and say "We are sorry, make a new pair for your client, and send us the bill". What happens?
The testing process does allow for a protecting membrane over the lens, usually a plastic bag.
U.S. Department of Health and Human Services...............................
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Devices andRadiological Health
The draft of this document wasissued on October 26, 2007.
Document issued on: September 2, 2010
45. Q. What are FDA’s processes for inspection and/or sampling fortesting of a shipment of lenses or sunglasses?
A. Ophthalmic devices are subject to inspection and/or sampling bythe FDA as part of FDA's efforts to determine the device's compliance with theact. FDA does not inspect every import entry. FDA may request additionalinformation or documentation, such as records of impact testing results, orrequest to examine the shipment. If FDA chooses to collect a sample, theDistrict Office typically notifies the import broker (or filer), the owner orconsignee, and importer of record (if different than owner or consignee) of itsintent to sample.
FDA provides official notification of the entry reviewer's decision to sampleby submitting a "Notice of FDA Action" sampling request.
Once FDA has been advised of the location and the availability of articles,the FDA personnel will visit the site to perform the examination and/or samplecollection. FDA's examination of the entry and sample collection cannot proceeduntil the agency receives the "notification of availability." Aftercollection of the sample, FDA typically provides an additional "Notice ofFDA Action" detailing the articles and amounts collected. If the articleis found to be in compliance after examination, the filer, importer of record,consignee, and the U.S. Customs and Border Protection (CBP) are notified by“Notice of Release” that the article may be admitted as far as FDA isconcerned.
46. Q. If FDA tests the shipment at the port of entry, how manylenses are tested?
A. FDA will test a statistically significant sample size in order todetermine compliance with the FDA impact test regulation. The sample size willdepend on the size of the shipment that FDA is testing.
47. Q. What does the FDA testing lab do with sunglasses/eyeglassesafter being tested?
A. Samples that are damaged are no longer suitable for use and arenot returned to the importer. If requests are made to a District Office for thereturn of any non-damaged samples, FDA tries to comply with the requests.
48. Q. What should I do if my shipment is refused admission?
A. FDA may issue a “Notice of Detention and Hearing” to refuseadmission of a shipment if the device appears to be in violation of section801(a) of the act (21 U.S.C. 381(a)). FDA issues the "Notice of Detentionand Hearing" detention to the broker (or filer), importer of record, andthe owner or consignee, where applicable. The notice will specify the nature ofthe violation charged and will designate the place and period of time duringwhich the owner or consignee (or authorized representative) can provide oral orwritten testimony as to the admissibility of the article.
See all of it ------------------------> http://www.fda.gov/medicaldevices/de...m070579.htm#15
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