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.