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

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

Lens production Testingper day Lenses /day Can fail

90 13 2150 20 3280 32 5500 50 71200 80 103200 125 14

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

Lens production Testingper week Lenses /week Can fail

280 13 2500 13 21200 20 33200 32 5

10000 32 535000 50 7

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

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 Party Date Sample Size Pass/Fail

Joe Smith 03/08/02 20 P

Joe Smith 03/15/02 20 P

Joe Smith 03/22/02 20 P

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?

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

VCA members are confident this Program meets FDA testing requirements

Lens manufacturers’ technical experts willing to assist labs

We Can Help