Here is the letter I sent to the FDA.

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Hello,

This letter is in regards to the STAAR Visian ICL (PMA #P030016).

I had a Visian lens implanted in my left eye on January 4, 2007.
That evening, I noticed some strange halo/starbursts surrounding
light sources (e.g. car headlights). The "visual artifacts" look
like two thirds of a spoked wheel surrounding every light. The image
I see contains many (hundreds) of fairly well defined lines
radiating from the light source. The lines terminate at a fairly
well defined edge, where the edge itself is a well defined bright
line. Also, there is a protruding secondary image from the primary
image. The result is an image that looks a lot like a snow angle,
where the head is the light source.

At about one week post op, I visited the doctor and he gave me an
eye exam, and corrected my remaining astigmatism using that test
lens device they use for figuring out one's prescription. The good
news was that my vision was 20/30 after correcting for my
astigmatism. The bad news was that the visual artifacts were still
there. They seemed unrelated to my astigmatism.

My doctor consulted with a STAAR field representative, and both the
doctor and the STAAR representative concluded that the vault of the
ICL was too high, and the ICL should be replaced with a smaller
version. They suspected that the high vault of the ICL was causing
the visual artifacts.

On January 18, 2007 my doctor preformed a second procedure to
replace the ICL with a new smaller lens. That evening, I checked my
vision, and unfortunately, the visual artifacts were still there.
They were just as big and bright as before.

My doctor tells me that the ICL has excellent placement, and the
vault looks great. He preformed a wave front analysis, and my cornea
looks fine. A Pentacam exam didn't reveal anything unusual. He's
doesn't know what is wrong.

I got a second opinion from another Ophthalmologist, but he also
concluded that the implant was properly installed.

I've contacted the STAAR company, and have worked with them somewhat
to determine the problem. I've had conversations with their head of
QA (Marcy Lake) as well as with Dr. Paul (head of R&D I believe) and
Dr. Ossipov (the inventor of the lens), but they do not know what is
wrong.

A note on STAAR. The people at STAAR have been somewhat responsive.
They are not proactive about solving my problem. I initially started
sending an email to them, but got no response. After two weeks I
called them. There help line was friendly, and told me that I would
hear back from someone in two weeks. I did not receive a call within
two weeks, so I called them again. I got the email address of the
head of QA (Marcy Lake) and sent her my information and requested
help. I got a reply saying that they would get back to me in a few
days. I waited a week, but did not hear back. A week and a half
after that Marcy replied. She set up a phone conference between me
and Dr. Paul and Dr. Ossipov. A few days later, we had the phone
conference. We talked for about 30 minutes, but were unable to
determine the cause of my problem. They requested the results from
my cornea mapping. I sent the information to them within a day or
two.

I've sent emails to Marcy requesting any status she might have on
the problem and I've asked for some additional information on the
exact optical diameter of my lens, but I have not received a reply
in over 2 months. I've also sent a letter to the

My opinion of the STAAR Company is marginal at best. There customer
service doesn't seem very good, and I'm surprised they do not wish
to follow up on a possible problem with their product.

I was/am an excellent candidate for implantation of the STAAR Visian
lens. I'm a 42 year old male. My eyes pre-op had the following
prescription:

Right = -16D x -2.25D x 108
Left = -18D x -1.75D x 065

Both my pupils dilated to about 5.75 mm. My best corrected vision
was 20/40.
Like may people, my pupils are off center and are somewhat nasal.

I suspect I fall into a minority of patients that have an
unacceptable result with the optical diameter of the STAAR Visian
lens. That is, the labeling of the STAAR lens states that the
optical diameter of the lens is between 4.9 and 5.8 mm. Since my
prescription is high, I'm guessing the optical diameter of my lens
is closer to the lower number (i.e. 4.9). My dilated pupil diameter
is larger, and therefore unfocused light enters my eye under low
light situations.

In conclusion, I would suggest the FDA expand the patient criteria
suitability for implantation of the STAAR Visian lens to include
diagnostics for pupil diameter and likelihood of unacceptable low
light vision. For example, I could imagine that the patient could be
given a contact lens to ware in low light conditions where the
diameter of the optical portion of the lens would be such that
patients would recognize visual problems in low light. In this way,
patients that have problems can be disqualified from the procedure.

I would also like to recommend that the labeling of the Visian lens
be changed to specify the exact optical diameter of each lens. That
is, the range currently given (i.e. 4.9 to 5.8) is not precise
enough. An exact diameter would give useful information.

Finally, I would greatly appreciate it if the FDA could contact the
STAAR Company and suggest they continue to investigate my visual
problems. I've contacted other STAAR patients, that suffer similar
night time visual problems, and it would seem be in the best
interest of the public as well as STAAR to follow up on problems
with their product.

Sincerely,

Kenneth A. Sell