**FDA Impact Resistance (CFR801.410) -- How will it effect you.**

*By: HarryChilinguerian ABO-AC, NCLE, COA*

Our industry often faces changes both for the good and for the bad, but
here we have an opportunity to make a difference. The FDA recently
proposed changes to the impact resistance document better known to
opticians as the "drop ball test". The major changes are outlined in
following article which shows how slight changes can have some
devastating impacts on how we do business. The full text can be read
here: <http://www.fda.gov/cdrh/dsmica/guidance/23.pdf> if after reading
this article you are left with a feeling of "what can I do", the
Opticians Association of America (OAA) and the Vision Council of America
(VCA) have teamed up to provide the FDA with enough information to make
the necessary changes to this document. You can help by writing to the
FDA, to make it easy the OAA has provided a form letter for ophthalmic
professionals to easily contact the FDA and make their voices be heard.
You an access that form letter here:
<http://capwiz.com/oaa/issues/alert/?alertid=10631926&PROCESS=Take+Action>

1.  **1. Q.** What are the impact testing requirements for prescription
    (Rx) glass lenses?

**A**. The manufacturer must test each finished Rx glass lens
individually for impact resistance (21 CFR 801.410(c)(3)). The lens must
be capable of withstanding the impact test provided in 21 CFR
801.410(d)(2) as described under "Testing Apparatus and Procedure"
below. You should perform testing after the lens has been edged (cut to
the shape of the frame) but before the lens is put into the frame.

The lenses being tested after being edged means that any small office
now fabricating eyewear will have the burden of testing and meeting
these requirements or they will have to farm the jobs out to a larger
lab negating any savings in both time and cost associated with edging in
house.

1.  **4. Q.** What are the impact testing requirements for prescription
    (Rx) and non-prescription plastic lenses?

**A**. Under 21 CFR 801.410(c)(3), you must test a statistically
significant sample of prescription or non-prescription plastic lenses
from each production batch. The sample must be representative of the
finished forms as worn by the wearer, including forms that are of
minimal lens thickness and have been subjected to any treatment. You
must test all nonprescription lenses in uncut-finished or finished form.
21 CFR 801.410(c)(3). You should perform testing on a sample after the
lens has been edged (cut to the shape of the frame) but before being put
into the frame.

Using statistical testing methods is a sampling method best employed by
large laboratories, this combined with testing edged lenses will create
an unnecessary burden on the retailer, but also a costly one as most
smaller offices that edge in house will have too few jobs coming through
the office to employ batch testing. The costs involved can in some cases
double the production cost to the retailer which will undoubtedly be
passed on to the end user in higher costs.

The answer also is very vague about the form in which the lens should be
tested uncut-finished, finished, and edged are all mentioned with little
in the form of which one would be the acceptable format to test the
lenses.

1.  **8. Q.** Is the manufacturer of semi-finished lens blanks required
    to perform the impact testing?

**A.** No. A semi-finished lens blank needs further processing that may
weaken the lens. You should test the finished lens.

The wording used in question #4 particularly "uncut-finished" could
create confusion with the term "semi finished" especially when the term
uncut-finished is followed by finished then edged. Traditionally
ophthalmic personnel have referred to lenses in three forms: semi
finished, finished, and edged. This consistency in the terms used can
help reduce the amount of confusion in the document.

1.  **10. Q.** Does impact testing apply to retailers that put plano
    lenses in sunglass frames or that put lenses into an eyeglass frame
    in which one lens is plano and the other lens is corrective?

**A.** Yes. In general, it is the retailer who usually grinds and shapes
lenses to fit the eyeglass frame. Retailers that process lenses (grind
and shape) must render the plano lenses impact resistant and test them.
However, retailers only need to test mass-produced plano lenses on a
statistically significant, batch-sampling basis (21 CFR 801.410(c)(3)).

By moving the testing from the manufacturer to the retailer level the
cost of testing would significantly increase and the statistical
methodology would be less efficient on the retail level than it would be
on the manufacturer's level.

1.  **11. Q.** Does impact testing apply to finished non-prescription
    sunglass lenses, i.e., sunglass lenses that need only to be inserted
    into a frame?

**A.** Yes. Under 21 CFR 801.410(c)(3), you must test a statistically
significant sample of sunglass lenses from each production batch. The
sample must be representative of the finished forms, including forms
that are of minimal lens thickness and have been subjected to any
treatment used to impart impact resistance. You must test all lenses in
uncut-finished or finished form. 21 CFR 801.410(c)(3). You should
perform testing on a sample after the lens has been edged (cut to the
shape of the frame) but before being put into the frame.

Same as previous questions the term uncut-finished, finished, and edged
should be reconsidered.

1.  **12. Q.** Are clip-on sunglass lenses subject to impact testing?

**A.** Yes (21 CFR 801.410 (c)(3)). However, FDA intends to exercise its
enforcement discretion regarding impact testing based on the following
factors:

1.  1\. Whether the clip-ons cannot be worn alone, but can only be worn
    with lenses that are impact resistant.

    2\. Whether the clip-ons are designed so that they may be worn only
    on the outside (side distal from the eye) of the prescription
    lenses.

    3\. Whether the clip-ons are the same size or smaller than the
    prescription lenses upon which they are intended to be worn.

The term clip-on makes it evident that these lenses are not designed to
work alone, but require an underlying base pair of spectacles. If these
base spectacles are treated then the clip-on will provide insignificant
safety therefore should not be considered when judging the impact
resistance of the eyewear.

1.  **21. Q.** Who should perform the test for impact resistance?

**A**. The manufacturer must perform the test for impact resistance (21
CFR 801.410(d)(1)). Manufacturer is defined under 21 CFR 820.3(o) and
would include the person (or firm) who puts the lens in the form ready
for its intended use or who alters the physical or chemical
characteristics of the lens by grinding, heat treating, beveling,
applying scratch resistant coating, applying anti-reflection coating,
cutting, or other pertinent actions. Retail laboratories that perform
some or all of these processes are manufacturers. For the purpose of 21
CFR 801.410, the term \"manufacturer\" also includes a company that
imports impact resistant lenses for eyeglasses, or who imports finished
eyeglasses or sunglasses for resale. (21 CFR 801.410(g))

The lens should meet the impact standard before reaching the retailer to
make sure that adequate safe guards are in place. A sad but common fact
known in the industry is the fact that half the states in the USA have
no licensing or training for ophthalmic personnel in the lab to perform
these tests to ensure that the lenses meet these impact standards, it is
my feeling that if the lenses meet the impact resistant standard in
their finished un-edged form the retailer will have a better chance of
ensuring the end user is protected against impact induced trauma, while
providing it at a significant cost savings over the retailer testing.

A document released by Ken Wood from the Vision Council of America
covers some of the major concerns brought out by this new Q and A about
impact resistant lenses.

1.  Testing after edging -- this creates an unnecessary burden on many
    in our industry.

2.  Retailer testing -- this creates an increase in the cost of
    production with higher amounts of lenses being discarded.

3.  Manufacturers must test while labs need not -- by changing the
    manufacturer from the lab to the retailer when operations such as
    tinting, edging, or coating are performed the labs are more likely
    to end the practice of testing surfaced and treated uncuts.

4.  Edger sales -- manufacturers of edgers rely on retailers as their
    major source of sales, if the responsibility of impact testing
    shifts from lab to retailer this will impact the sales of edgers.

5.  Frames distribution -- the change from retailers edging to labs
    edging will require that frame distributors will have to provide
    more accurate trace and drill data to labs to ensure quick
    processing of lenses for the retailer, or the labs will have to
    start stocking frames.

I personally though these points were well though out. I would also add
that the cost and burden created on the retailer would be both
unnecessary and costly, this will lead to either higher costs for the
end user or longer waits for spectacles since production would be moved
from the retailer to the lab. This would both inconvenient to the end
user with higher turn around times and financially. Frame manufacturers
will also see an increase in their burden as they will need to provide
more accurate trace data therefore they would need to have stricter
tolerances for frame circumference sizes which can increase the cost of
frames. The testing being moved from a lab to the retailer will
ultimately require more untrained personnel to test lenses for impact
resistance therefore increasing the risk to the general public.