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COLTS’
Offers FDA Program to Dispensers |
COLTS Laboratories, a
well known testing facility in the ophthalmic community is
now offering a plan for edging dispensers so that they are
eligible for an FDA compliance certification from COLTS for
the impact resistance for the plastic lenses that they
produce for the consumer.
The program calls for a
representative sample of lenses that are past prescriptions,
randomly chosen, that they have dispensed. These surfaced
and coated lenses must then be edged by the dispenser and
sent to COLTS for testing every quarter. These four sets of
lenses will be impact tested using our FDA accepted impact
program.
COLTS has the only
impact program that has been accepted by the FDA other than
the FDA’s own program. The COLTS’ program requires
between 75% to 86% fewer lenses be impact tested to meet the
requirement for compliance. More importantly the failure
allowance in testing is normally 6.5% in the standard FDA
protocol but is only 0.3% to 1.3% in the COLTS FDA protocol
(depending on the sample size). This means that there is
significantly less chance of the plaintiff’s attorney for
little Susie, who has lost vision in one eye from an
accident, to ask why you let her wear a lens from the 6.5%
failed lens category?
You
can contact COLTS at info@coltslabs.com
for more information and application forms or at
727-725-2323. |
