Import Alert 86-04
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(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).
Import Alert # 86-04
Published Date: 04/10/2012
Type: DWPE
Import Alert Name:
"Lax-Optics Lensless Spectacles (Pin-Hole Glasses)"
Reason for Alert:
Product consists of a grid pattern of pinholes in an opaque material in place of normal transparent lenses. According to the promotional literature accompanying the device, "The LAX OPTICS can do the following for you: (1) Enable you to see more clearly without your normal glasses immediately, (2) Encourage your eyes to completely relax, with consequent beneficial results."
Lax optics claim to be advantageous to people with irregular stigmatism, conical corneas, cataracts and retinal separation as well as being effective in reducing eye strain and sensitivity to sunlight glare or brilliant lights. Even people with normal vision are urged to wear the spectacles to prevent any deterioration of vision in the future.
Shipments have also been accompanied by literature offering an adjunct device called the "Intensive Ciliary Exerciser Oscillator (ICE)". According to the literature the "ICE" is a perfect compliment to the Lax Optics Lensless Spectacles. The exercise to the eye muscles induced by the "ICE" balances the relaxation to the eye resulting from wearing the Lax Optics spectacles.
The firm has not submitted a 510(k) premarket notification nor has it listed either device as required by Section 510 of the Act. These devices are also in violation of the Act since adequate directions for use cannot be written for ineffective devices.
Lax optics claim to be advantageous to people with irregular stigmatism, conical corneas, cataracts and retinal separation as well as being effective in reducing eye strain and sensitivity to sunlight glare or brilliant lights. Even people with normal vision are urged to wear the spectacles to prevent any deterioration of vision in the future.
Shipments have also been accompanied by literature offering an adjunct device called the "Intensive Ciliary Exerciser Oscillator (ICE)". According to the literature the "ICE" is a perfect compliment to the Lax Optics Lensless Spectacles. The exercise to the eye muscles induced by the "ICE" balances the relaxation to the eye resulting from wearing the Lax Optics spectacles.
The firm has not submitted a 510(k) premarket notification nor has it listed either device as required by Section 510 of the Act. These devices are also in violation of the Act since adequate directions for use cannot be written for ineffective devices.
Guidance:
Districts may detain, without physical sampling, any shipment of these products.
Districts should alert local Customs officials that this product may be entering through both formal and informal channels (mail, small shipments, etc.).
Districts should alert local Customs officials that this product may be entering through both formal and informal channels (mail, small shipments, etc.).
Product Description:
Pinhole Eyeglasses, a/k/a Lax Optic Lensless Spectacles Intensive Ciliary Exerciser Oscillator (ICE).
Charge:
"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears that the device has not been listed as required by Section 510(j). [Misbranding, 502(o)]"
OASIS charge code - NOT LISTED
OR
"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears that a premarket notification has not been submitted pursuant to Section 510(k). [Misbranding, 502(o)]"
OASIS charge code - NO 510(K)
OR
"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to lack adequate directions for use. [Misbranding, 502(f)(1)]"
OASIS charge code - DIRECTIONS
OASIS charge code - NOT LISTED
OR
"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears that a premarket notification has not been submitted pursuant to Section 510(k). [Misbranding, 502(o)]"
OASIS charge code - NO 510(K)
OR
"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to lack adequate directions for use. [Misbranding, 502(f)(1)]"
OASIS charge code - DIRECTIONS
Countries
MULTIPLE COUNTRIES (PODS ONLY)
(86 H - - QG) Lens, Spectacle, Non-Custom (Prescription)
(86 H - - QZ) Frame, Spectacle
SOUTH AFRICA
Institute for Vision Improvement
Date Published : 09/16/2009
P.O.Box 7840 , Johannesburg, SOUTH AFRICA
86 H - - QG Lens, Spectacle, Non-Custom (Prescription)
Date Published: 09/16/2009
86 H - - QZ Frame, Spectacle
Date Published: 09/16/2009
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