Results 1 to 3 of 3

Thread: HELP! I need a lab who can do a drop ball test in the USA

  1. #1
    Bad address email on file
    Join Date
    Oct 2011
    Location
    Costa Mesa
    Occupation
    Other Optical Manufacturer or Vendor
    Posts
    1

    Confused HELP! I need a lab who can do a drop ball test in the USA

    We have a shipment of sunglasses from China that are stuck in US Customs the FDA will not release them to us and they're almost a month late we're loosing sales every day we don't have these!

    I have been told that our lens supplier is not using an appropriate acceptable standard.
    I need a private laboratory that can get the glasses from the FedEx warehouse in Oakland and perform the drop ball asap.

    I have no idea where to look as our factory always does the drop ball test for us.

    Thank you!

  2. #2
    Bad address email on file
    Join Date
    Jun 2000
    Location
    1/2 China, 1/2 California
    Occupation
    Frame Manufacturer
    Posts
    756
    Tell ur supplier from China to get the right ones and submit again to freight forwarder!



    QUOTE=eyewars;400214]We have a shipment of sunglasses from China that are stuck in US Customs the FDA will not release them to us and they're almost a month late we're loosing sales every day we don't have these!

    I have been told that our lens supplier is not using an appropriate acceptable standard.
    I need a private laboratory that can get the glasses from the FedEx warehouse in Oakland and perform the drop ball asap.

    I have no idea where to look as our factory always does the drop ball test for us.

    Thank you![/QUOTE]

  3. #3
    Manuf. Lens Surface Treatments
    Join Date
    Aug 2002
    Location
    in Naples FL for the Winter months
    Occupation
    Other Optical Manufacturer or Vendor
    Posts
    23,240

    Blue Jumper Testing needed before insertion into frame.........................

    Quote Originally Posted by eyewars View Post

    I have been told that our lens supplier is not using an appropriate acceptable standard.


    Obviously you purchased from a supplier that is not registered with the FDA. That makes it short and sweet for the FDA to block it at customs. You will have to have the whole shipment tested one by one and even then it is not guaranteed that it will be released.

    Best solution is to send it back by Fedex and get a refund from whoever you bought it and paid in advance, because FDA registration will take a while for an approval and you will be stuck with Fedex storing charges.

    Check drop ball test rules: http://www.allaboutvision.com/safety/safety-glasses.htm

    Guidance for Industry and FDA Staff - Impact-Resistant Lenses: Questions and Answers

    Sunglasses

    10. Q. Does impact testing apply to finished non-prescription sunglass lenses, i.e., sunglass lenses that need only to be inserted into a frame?

    A.
    Yes. Under 21 CFR 801.410(c)(3), you must test a statistically significant sample of sunglass lenses from each production batch. The sample must be representative of the finished forms, including forms that are of minimal lens thickness and have been subjected to any treatment used to impart impact resistance. You must test all lenses in uncut-finished or finished form.

    21 CFR 801.410(c)(3). If you choose to test the finished form, you should perform testing on a sample after the lens has been edged (cut to the shape of the frame) but before being put into the frame.

    11. Q.
    Are clip-on sunglass lenses subject to impact testing?
    A. Yes (21 CFR 801.410 (c)(3)). However, FDA intends to exercise its enforcement discretion regarding impact testing based on the following factors:
    1. Whether the clip-ons are the same size or smaller than the prescription lenses upon which they are intended to be worn.





    From: http://www.fda.gov/medicaldevices/de...cm070579.htm#8
    Chris Ryser
    ________________________________________
    DLO. NA.IC.I.T.PO

    http://optochemicals.com............................. http://arcoatings.com

Thread Information

Users Browsing this Thread

There are currently 1 users browsing this thread. (0 members and 1 guests)

Similar Threads

  1. FDA reg no. and 510K number, drop ball test certificate
    By Lawrence Yau in forum General Optics and Eyecare Discussion Forum
    Replies: 20
    Last Post: 03-29-2013, 04:38 AM
  2. Drop ball testing
    By Kurt in forum General Optics and Eyecare Discussion Forum
    Replies: 23
    Last Post: 01-14-2009, 03:53 AM
  3. The new *Drop-Ball* Fiasco
    By Barry Santini in forum General Optics and Eyecare Discussion Forum
    Replies: 1
    Last Post: 01-07-2008, 10:12 AM
  4. Drop Ball Sizes
    By Sleepy_Lab_Rat in forum General Optics and Eyecare Discussion Forum
    Replies: 7
    Last Post: 12-08-2003, 07:49 PM
  5. Automatic drop ball testers
    By optidan in forum General Optics and Eyecare Discussion Forum
    Replies: 1
    Last Post: 09-06-2001, 06:41 AM

Tags for this Thread

Bookmarks

Posting Permissions

  • You may not post new threads
  • You may not post replies
  • You may not post attachments
  • You may not edit your posts
  •  
OptiBoard is proudly sponsored by:
Younger Optics and Vision Equipment