From: "steve"
<____@____.com>
To: <brent@lasikcourt.com>
Sent: Monday, July 22,
2002 3:48 PM
Subject: Lasik, B&L
& TLC my thoughts
I found your site very interesting. For 14 years I was involved in the
development of the MicroKeratome that were marketed by Bausch & Lomb. I had
a great deal of experience with TLC when I worked as the service department
supervisor for Bausch & Lomb. 13 years ago I started worked on the
prototypes for the ACS MicroKeratome and 3 years ago I was there when Bausch
& Lomb bought Hansa Research & Development Corporation, the true
developer.
I was the production supervisor in charge of manufacturing parts up until May of
2002. I actually had a hand in the development of the ACS and Hansatome. I am
probably one of the top 5 individuals with the most knowledge about its problems
and shortcomings. I was discarded during restructuring in May as the local plant
began a series of cutbacks.
About TLC? MicroKeratome returned for service from TLC were some of the worst
kept medical devices imaginable. Dirty and beat up by a group of doctors that
share equipment like you rent bowling shoes. The problem with a group of people
sharing the use of delicate equipment is that nobody cares about its upkeep.
Units were treated like tools, wrenches and screwdrivers, and tossed around like
the toolbox in the trunk of your car. The people at TLC were the worst to deal
with. Demanding quick fixes to destroyed equipment and the blame was always the
equipment never the user.
Bausch & Lomb has now developed it's own more serious problems. In January
of 2001 a new plant manager took over the facility here in Miami, Florida where
the first MicroKeratome was built and where the Hansatome is produced.
From then till now that facility has undergone a series of cutbacks that
effected quality and will be the end of the Hansatome project. That new manager
had a personal falling-out with the previous manager and decided to replace the
entire power structure of the facility to spite him. He has now done that by
neutralizing 5 key people. Unfortunately for the project he has neutralized the
supporting knowledge base. The people building Hansatomes were once surgical
instrument makers and machinist. Now the device is built by housewives and
teenagers in an assembly line production. You can figure out what happened to
the quality.
Anyway this last year the production has gone down hill fast and here is a copy
of my letter to the FDA in June, I fear they will not take is seriously. This
facility needs attention.
Bausch & Lomb Miami
The Bausch & Lomb facility at 7790 NW 55th St. in Miami Florida is engaged
in the production of the surgical instrument known as the Hansatome Micro
Keratome. In this last year the quality of the product has deteriorated to a
dangerous level. This effort to reduce cost, cut corners and implement assembly
line type manufacturing has now out weighed the need to maintain quality, in
this product that actually cuts the human eye. Actual patient injuries have
occurred as a result of this effort to cut cost while boosting output. The
Repair Dept. covers those tracks. Micro Rings and Micro Heads are being produced
in volume without the necessary Quality Controls. The current Quality Manager is
in the process of being replaced for voicing his concerns.
The rush to bring the new Z-Heads, Micro Suction Rings and the new 20MM Micro
Suction Rings into production, was driven by Marketing and should have required
a new 510(k). All other factors take a back seat to that need to hit the market
with a new generation device. We are engaged in developing the new prototypes
and at the same moment the plant manager is cutting resources. Reducing wages
for supervisors and reduced hours for employees.
Reduced availability of tools and equipment. Cutting corners. Gages, measuring
tools and cutting tools are in short supply. SPC is non existent and created
after the fact as needed.
The design measurements and calculations for the calibration of the Z-Heads are
flawed. The prototypes used in the clinical tests were re labeled several times
since they did not produce the expected results. They did not cut the correct
thickness as predicted by engineering so the numbers on the heads were changed
several times. The design was never reevaluated and under pressure from the
plant manager the project pushed forward to production and product release in
order to meet his timeline. The actual heads used in the clinical evaluation do
not match the manufacturing drawings for the release.
Many small changes have gone undocumented in the effort to push forward.
This device is claimed to cause less compression on the flap when in fact it
increases the compression of the entire eye and it is much greater pressure than
the ACS unit. Several design changes have inched the Micro Keratome head closer
to the eye increasing the IOP. So many Micro Heads were produced so fast that
the documentation could not keep up causing heads with similar labels in
inventory to have differing dimensions. This creates confusion when
calibrating and installing these heads in new and service units.
The manufacturing process for Micro Suction rings and the new 20MM Ring has
never been perfected even though production of the rings has increased. The
development suffered from cutbacks. The FAIR's on the 20mm rings were done long
after the rings were in clinical testing and were not done on the same rings
used in the testing. On the Micro Suction rings, discrepancies in the
measurements that control the exposure of the cornea above the ring have caused
many Free Flaps as noted by the service department. Quality control in the
manufacturing is lacking because of increased volume and cutbacks.
Many rings have varying dimensions. Defective rings are taken out of service or
modified when found in service units.
There are massive across the board discrepancies in documentation of Prints,
PCPs, SOPs and manufacturing procedures that are incorrect. Actual print
dimensions are in error in many cases. This is made worse by cutbacks and
restrictions in an effort to save money. GMP and ISO are the goals but the
facility is in a state of disarray at this moment. The employees are working
blind with an ever growing pressure by the manager to produce more volume in
less time. When B&L bought this company 2 years ago documentation was
minimal. Much of it was created immediately by a remote engineering department
in many cases by people with no knowledge of the device. It was incomplete and
flawed and in need of repair. In the last 2 1/2 years only small progress has
been made in correcting the documentation and in the last year that correction
process has been all but abandon. Procedures for such things as Part Machining,
Assemble, Heat Treating, Hardness Testing and Servicing are in need of
attention. These documents are incomplete and not understood by the employees.
This is due to lack of resources, cutbacks in financing and personnel, lack of
proper training and the unyielding pressure to produce more with less and to do
it in less time.
Steve ____
X Production Supervisor
Bausch & Lomb Miami