Dr. Trattler,

Here is the text of an e-mail from an individual who claims to be a former manager at B&L. I would like to know if lasik surgeons still use the Hansatome, and if they are aware of the alleged defects.

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From: "steve" <>
To:
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

Dr. Trattler,

Here is an article describing a product liability lawsuit against Bausch & Lomb. Yesterday I talked to the attorney who is representing the patient in this case. He states that he has been getting a lot of calls from patients who claim to have been damaged by the Hansatome microkeratome. The lawyer states that he is considering converting the lawsuit into a class action.

Do you believe that patients who have been injured by the Hansaome should be compensated for their injuries by Bausch and Lomb. If so, should the patients file individual lawsuits, or should they seek reparations as part of a class action?

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CUTTING CORNEAS: $40M EYE-SURGERY LAWSUIT

Local - New York Post

CUTTING CORNEAS: $40M EYE-SURGERY LAWSUIT
Sat Dec 7, 4:59 AM ET Add Local - New York

Associated Press

An upstate woman who says she sustained eye damage when a blade snapped during laser vision-correction surgery is suing blade maker
Bausch & Lomb Inc. for $40 million.

Sharon Guess, a Rochester resident in her late 30s, said the mishap erratically cut her cornea during an operation in March 2001 and caused heavy scarring that left her with hazy vision in her right eye.

She maintains in a lawsuit filed this week in state Supreme Court that the eye-care products maker distributed the single-use blade with a known defect - a weak spot capable of breaking when subjected to stress.

The doctor who performed the surgery was not named as a defendant. "At this point, I'm unaware of anything that he may have done wrong to break the blade," said Guess' attorney, Albert Parisi.

The blade, called an Accuglide, is made in a St. Louis laboratory that has an "extraordinary safety profile and history of effectiveness," company spokeswoman Margaret Graham.

She declined to discuss the suit's specific allegations, but maintained no other suits challenging the blade's safety have been filed.

Americans will undergo more than a million LASIK procedures this year to correct blurry eyesight. It's quick and painless: Doctors cut a flap in the cornea, aim a laser underneath it, and, with a zap, reshape the cornea for sharper sight.

Most lawsuits resulting from the procedure are aimed at surgeons who fail to properly screen patients or incorrectly calibrate the laser, B. Kent Buckingham, a former eye doctor who now practices medical malpractice law in Midland, Texas, said in yesterday's Rochester Democrat and Chronicle.

Hi Bill ...

QUESTION #1 ...
If a LASIK surgeon uses a micro-keratome blade to perform a LASIK surgery, and that micro-keratome blade is covered with metal dust, is that LASIK surgeon operating below the standard of care ?

QUESTION #2 ...
A certain acuity of vision is required to see if a micro-keratome blade is covered with metal dust. Do you think it's appropriate to require refractive surgeons to have a quality of vision that could be characterized as "eagle-eyed near-sighted vision" ?

QUESTION #3 ...
If you do think it's a appropriate for a refractive surgeon to have "eagle-eyed near-sighted vision", and you were advising a state medical board regarding the assessment of corneal surgeons' vision, how would you propose to measure that superlative vision ?

Roger

Good questions Roger. Here is an article that suggests all the Hansatome microkeratomes were contaminated at the factory.

"The Jerusalem Study"

http://www.lasikdisaster.com/bausch_and_lomb.htm

If there is any metallic dust on a blade - it would be impercetible to the naked eye. As well - even under high magnification - it could be very difficult to see.
I have never used the Hansatome, although obviously this is a very popular type of microkeratome.
I have met Dr (or Mr.) Hansa, the person who developed the Hansatome a few years ago. I believe he lives in Miami, and it is my understanding that the Hansatome factory is somewhere in Miami.
The comments by Steve are very concerning, and should be looked into immediately.

Bill Trattler, MD
Miami, FL

Bausch & Lomb Recalls Defective Blades

A recent letter from the AAO to its members states that after receiving a number of reports of patients experiencing diffuse lamellar keratitis after LASIK procedures, Bausch & Lomb Incorporated (Rochester, NY) issued a recall of a defective batch of its Accuglide disposable microkeratome blades. The incidence of diffuse lamellar keratitis is believed to be associated with two specific blade lots, 517984 and 517985. For more information, contact company representative Pam Bittner at , ext. 5252.

Bausch & Lomb Recalls Defective Blades

A recent letter from the AAO to its members states that after receiving a number of reports of patients experiencing diffuse lamellar keratitis after LASIK procedures, Bausch & Lomb Incorporated (Rochester, NY) issued a recall of a defective batch of its Accuglide disposable microkeratome blades. The incidence of diffuse lamellar keratitis is believed to be associated with two specific blade lots, 517984 and 517985. For more information, contact company representative Pam Bittner at , ext. 5252.

"In September 2001, my clinic encountered an unexpected epidemic of diffuse lamellar keratitis (DLK), despite the extensive preventive measures we routinely employed. Although we attempted to eliminate each of the many factors that experts have suggested may cause this complication, we failed to halt the outbreak. A quality assurance engineer pointed out that the only variables that were constantly changing in our setup were the microkeratome blades, which come ready to use in sterile packages. The engineer suggested that a lubricating oil used during the manufacturing process might adhere to the metallic surface and not dissolve completely in water. Because these oils are known to dissolve in alcohol, wiping each blade with sterile100% ethanol alcohol before attaching it to the microkeratome seemed a reasonable solution."

"CLINICAL TRIAL
We observed 24 patients (48 eyes) who had each undergone LASIK by a single surgeon on the same day. The surgeon used the same setup and instrumentation for each patient, including blades manufactured in the same batch and a Hansatome microkeratome (Bausch & Lomb, San Dimas, CA)."

.
.
.

"CONCLUSION
We believe that wiping microkeratome blades with alcohol has “cured” an epidemic of DLK in our clinic, and has since helped to prevent new cases of the complication."

http://www.crstoday.com/03_archive/0602/crst0602_151.html

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"Regarding the Hansatome and all sterilization equipment, we meticulously follow manufacturer recommendations for their use and maintenance. Your request that all Hansatome blades be wiped with alcohol is not approved by the manufacturer."

Joseph B. Dzialo
President and COO
LCA-Vision Inc.
December 20, 2002

http://www.lasikcourt.com/bausch/lcaletter.pdf

Al Parisi
130 E. Main St., Ste 435
Rochester, NY 14004

You can download a copy of the lawsuit here: http://www.lasikcourt.com/bausch/guess_vs_bausch.pdf