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Alcon recalls its SKBM microkeratome
The device will be discontinued. Alcon has no plans to introduce another microkeratome.
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FORT WORTH, Texas — Alcon Surgical is recalling all Summit Krumeich-Barraquer microkeratomes currently in use because of a possible defect that could lead to patient injury. The device is being discontinued.
According to the company, the adhesive that holds the applanation window in place may degrade and allow the window to become misaligned, which could lead to patient unjury due to uncontrolled depth of cut.
Alcon sent a letter to SKBM users on Nov. 18 informing them of the problem and telling them to stop using the microkeratome immediately.
The recall follows four reports of patients who suffered injuries the company attributes to misalignment of the applanation window.
“Patient safety is extremely important to us. Although there were only four injuries, and that is not many, we were concerned. Our testing indicated that to correct the problem, to be sure there would be no more injuries, would take too long. We decided to recall it,” Mary Dulle, a spokesperson for Alcon, told Ocular Surgery News.
The first incident occurred in the United States in August 2001. In its investigation, the company was unable to replicate what might have occurred to cause the injury, a statement said.
The company received a second report of patient injury occurring outside the United States in June 2002.
At that time, because the company could not replicate the injuries and determine their causes, it issued a safety alert in July 2002 by overnight mail to all SKBM owners and facilities the company believed had an SKBM on premises. The safety alert informed surgeons and physicians of the problem and advised them to ensure that the applanation window was properly aligned with the suction ring before beginning each individual procedure in every patient.
Following the safety alert, the company learned of two additional instances of patient injury, both of which occurred outside the United States. The company decided on the recall to prevent additional injuries.
According to the company, the microkeratome had made cuts at depths beyond what was desired. No patients were blinded; however, two may require corneal transplants.
Laboratory testing led the company to believe the applanation window was becoming misaligned due to degradation of the adhesive used to hold the window in place.
“We did see some degradation of adhesive and some movement of the glass. So we sent out the alert,” Ms. Dulle said. “In our testing, when the glass became misaligned, there were deeper flaps than usual. But when we were able to align it everything was OK. That seemed to us to be the probable cause.”
The letter informing surgeons of the recall contained a form for surgeons to complete to inform Alcon of the serial numbers, number of units and SKBM components the surgeon holds. The form is to be sent back to Alcon for the company to process either a refund or a credit to the surgeon’s account, depending on surgeon preference.
The company currently does not plan to reintroduce a new version of the SKBM. Alcon said it has no plans to develop a new microkeratome to replace the SKBM at this time.
Under the recall, Alcon is reimbursing 100% of the purchase price for SKBM units bought after Oct. 31, 2001. For units purchased between Oct. 31, 2000 and Oct. 31, 2001, the company is reimbursing 75% of the purchase cost. A fixed dollar amount is being provided for units purchased before Oct. 31, 2000.