IA#86-04, ----1/17/92
TYPE OF ALERT : Automatic Detention
PRODUCT : Pinhole Eyeglasses, a/k/a Lax-Optic Lensless Spectacles;
Intensive Ciliary Exerciser Oscillator (ICE).
PRODUCT CODE : 86HQZ[][];
86HQG[][]
HARMONIZED
CODE : 9004.10.0000 5
PROBLEM : Device is not listed (DVNL);
Unapproved/unfiled premarket application (DVUU)
COUNTRY : South Africa (ZA, 801)
MANUFACTURER/
SHIPPER : The Institute for Vision Improvement
P.O. Box 7840
Johannesburg, South Africa
MANUFACTURER/
SHIPPER I.D.# : N/A
IMPORTER'S
I.D.# : N/A
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)]"
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)]"
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)]"
RECOMMENDING
OFFICE : Center for Devices and Radiological Health, HFZ-300
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
astigmatism, 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.
INSTRUCTIONS : Automatically 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.).
KEYWORDS : Pinhole, Eyeglasses, Lensless, Vision Improvement,
Lax-Optics, Oscillator
FOI : No purging required.
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