Popular SKBM microkeratomes are recalled as product line is terminated

By Sean Henahan

FORT WORTH, TX — In a surprise move, Alcon Laboratories has recalled the popular SKBM microkeratome because of a defect in the adhesive that holds the applanation window in place.
The recall followed four reports of patient injuries which were associated with deterioration of the adhesive. The applanation window apparently became misaligned following degradation of the adhesive.

The result was the creation of deeper than intended flap incisions. No patients were blinded but some may require corneal transplantation.
The applanation or ‘preview’ window was a key feature of the automated Summit Krumeich-Barraquer microkeratome. A calibrated, transparent applanation plate provided complete visualisation of the cornea and the diameter available for the flap.
The plate helped to hold the cornea in place to provide pressure and counter-traction. Proponents said this produced smoother flaps and stromal beds

The recall includes all models of serial numbers of the SKBM and Lasitome microkeratome systems. All components of the system are included in the recall.
The company has asked anyone owning these systems to stop using them immediately and to return all the units to Alcon.

“The SKBM recall was the responsible thing for Alcon to do, given the facts. Like many surgeons, I had to reschedule cases. Hopefully these patients will not be frightened away from LASIK or find another surgeon.
“I am borrowing a microkeratome while I assess my options. Surgeons are quite upset about the refund schedule and that Alcon is getting out of the microkeratome business entirely,” a surgeon told EuroTimes.

Some 350 microkeratomes are affected by the worldwide recall. Company engineers determined that it would not be cost effective to fix the problem and so the company decided to terminate the SKBM product line.
“I am very saddened by the recall because I think the unit is excellent and it allowed me to operate on thin corneas and to create predictable thin flaps for high myopia corrections, to operate on very flat corneas, and eyes with previous incisional surgery. I have to look for a microkeratome system that can do some of these things,” said another surgeon who used the SKBM regularly.

SKBM owners will have to hurry if they want to take advantage of the refund programme. The company says it will refund the entire purchase price of any SKBM keratomes bought after October 31st, 2001.
The company will refund 75% of the cost of products purchased between October. 31st, 2000 and October 31st, 2001. Those who purchased a unit before October 31st, 2000 will receive a lesser amount.

Alcon Laboratories Inc, based on Fort Worth, Texas, is a unit of Swiss corporate giant Nestle SA. An initial public offering of Alcon shares in 2002 was one of the few bright moments on the New York Stock Exchange.

Alcon says it anticipates making a fourth-quarter charge of $15 million for the recall and the termination of the SKBM product line. Sales of the SKBM were not a major part of the company’s bottom line, accounting for less than half a per cent of worldwide sales. Alcon acquired the microkeratome line when it acquired Summit Autonomous Inc in 2000.

For contact information please visit the Alcon website at http://www.alconlabs.com.

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