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VCA - Impact Resistance Testing Progam. “10 easy steps to implement a low cost system”. Simple & Minimal Cost. 20 Lenses Each Week Virtually no Lens Cost 1 Hour Per Week Labor. Define Your Test Batch. 1. Wide Latitude from FDA 1 day or 1 week Batch Size.
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VCA - Impact Resistance Testing Progam “10 easy steps to implement a low cost system”
Simple & Minimal Cost • 20 Lenses Each Week • Virtually no Lens Cost • 1 Hour Per Week Labor
Define Your Test Batch 1 • Wide Latitude from FDA • 1 day or 1 week Batch Size
Batch Size & Inspection Level 2 • Begin with General Level II • Z1.4 table I Specifies Sample Size
The Correct Sample Size for the Batch 3 • Why we use a 6.5 AQL • Using table II • Determines lens quantity • Acceptable number of failures • 200 lenses/day example:
Sample Size First 10 days of testing
Selecting Lenses for Test 4 • “Random sampling” is easiest • Matching your sales mix
Minimize Cost with Confidence 5 • Daily General Level II for 10 days • Move to S-4 with confidence • Redefine the batch to 1 week • Example:
Sample Size Regular weekly testing
Batch size of 200 lens per day • General Level II, daily testing • 32 lenses tested • 5 lenses can fail in acceptable batch • S-4, weekly testing • 20 lenses tested • 3 lenses can fail in acceptable batch
Who Tests AR Coated Lenses 6 • Samples must be made for test • Either party can test • Combining your testing reduces costs
Documentation Required 7 • Record your batch definition • Record test results regularly • Who, when, # samples, pass or fail • Test log example:
Individual Lens Failures 8 • Individual lenses may fail • Identify the product and inspect it • Make notes to discover trends
What if a Batch Fails 9 • Inspect the failures • Retest or go back to general level II • Retain the failures • Consult your suppliers
Isolate Problem Products 10 • Suspend shipment of this product • Test this product separately • Qualify this lens by general level II
What permits the FDA test to be simple and inexpensive? • Does not cosmetically damage most lenses • Hard coated lenses with AR coating? • FDA intended for good product to be tested and sold • FDA excludes Flat Tops • Title 21 CFR 801.410 c(3) states • “... Raised multifocal lenses shall be impact resistant but need not be tested beyond initial design testing.”
The FDA is Clear • The final processor must test • This has not changed since 1972 • Contact your lens manufacture
How can testing be this simple and inexpensive? • Sampling plan allows small sample size • Reject lenses are AR coated for test; no cost • No cosmetic damage to most lenses • FDA Intended lenses be tested and sold
Packaging Statement • "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 801.410. 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
We Can Help • VCA members are confident this Program meets FDA testing requirements • Lens manufacturers’ technical experts willing to assist labs