Alcon recalls SKBM

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 deteriorate and allow the window to become misaligned, which could lead to the creation of corneal flaps of excessive depth.

The recall follows four reports of patients who suffered injuries the company attributed 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.

According to the company, the microkeratome had created flaps at depths beyond what was physically desired. No patients were blinded; however, two may require a corneal transplant.

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.

More details on the recall will be published in an upcoming issue of Ocular Surgery News.