My thoughts: A letter written regarding B&L

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 affected 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

Bausch & Lomb – Technolas 217A

http://www.fda.gov/cdrh/pdf/p990027s004b.doc 

Summary of Safety and Effectiveness Data

The occurrence rate for the symptoms dryness (22.6% vs. 10.5%, p<0.0001), gritty feeling (6.8% vs 2.6%), fluctuation of vision (14.7% vs. 5.7%, p-value = 0.0005), and variations of vision in dim light (18.1% vs. 27.9%, p<0.0032) were higher at the 6 month visit than at the preoperative visit.