VCA - Impact Resistance Testing Progam “10 easy steps to implement a low cost system”

Simple & Minimal Cost t 20 Lenses Each Week t Virtually no Lens Cost t 1 Hour Per Week Labor

Define Your Test Batch  Wide Latitude from FDA  1 day or 1 week Batch Size 1

Batch Size & Inspection Level  Begin with General Level II  Z1.4 table I Specifies Sample Size 2

The Correct Sample Size for the Batch  Why we use a 6.5 AQL  Using table II  Determines lens quantity  Acceptable number of failures  200 lenses/day example: 3

Sample Size First 10 days of testing

Selecting Lenses for Test  “Random sampling” is easiest  Matching your sales mix 4

Minimize Cost with Confidence  Daily General Level II for 10 days  Move to S-4 with confidence  Redefine the batch to 1 week  Example: 5

Sample Size Regular weekly testing

Batch size of 200 lens per day t General Level II, daily testing –32 lenses tested –5 lenses can fail in acceptable batch t S-4, weekly testing –20 lenses tested –3 lenses can fail in acceptable batch

Who Tests AR Coated Lenses  Samples must be made for test  Either party can test  Combining your testing reduces costs 6

Documentation Required  Record your batch definition  Record test results regularly  Who, when, # samples, pass or fail  Test log example: 7

Test Log Page

Suggestions Beyond The Regulation

Individual Lens Failures  Individual lenses may fail  Identify the product and inspect it  Make notes to discover trends 8

What if a Batch Fails  Inspect the failures  Retest or go back to general level II  Retain the failures  Consult your suppliers 9

Isolate Problem Products  Suspend shipment of this product  Test this product separately  Qualify this lens by general level II 10

What permits the FDA test to be simple and inexpensive? t Does not cosmetically damage most lenses –Hard coated lenses with AR coating? t FDA intended for good product to be tested and sold t FDA excludes Flat Tops –Title 21 CFR c(3) states –“... Raised multifocal lenses shall be impact resistant but need not be tested beyond initial design testing.”

The FDA is Clear t The final processor must test –This has not changed since 1972 t Contact your lens manufacture

How can testing be this simple and inexpensive? t Sampling plan allows small sample size t Reject lenses are AR coated for test; no cost t No cosmetic damage to most lenses t FDA Intended lenses be tested and sold

Packaging Statement t "As a component, lenses of this design have been shown by testing to be capable of being processed to meet applicable Impact Resistance requirements of FDA regulation 21 CFR Conformance to this standard is the responsibility of all subsequent processors. Impact Resistant lenses are not unbreakable. Obviously damaged lenses should be replaced immediately."

How Easy is This! VCA Impact Testing Program Weekly testing of a few lenses Random sampling Low cost for lenses and labor

t VCA members are confident this Program meets FDA testing requirements t Lens manufacturers’ technical experts willing to assist labs We Can Help