Alcon Inc has commenced a voluntary recall of the SKBM microkeratome, which it obtained as part of its acquisition of Summit-Autonomous Technologies Inc. The company decided to recall the units after receiving a very small number of complaints that the applanation glass on the head of the handpiece could loosen or become misaligned. If not checked for misalignment, the corneal flap could be made at an undesired depth, which, in rare instances, could lead to patient injury.
Alcon took this pro-active approach voluntarily because of its long-standing commitment to maintaining the highest standards of product quality and patient safety.
Alcon estimated there are about 350 units in the worldwide market today. Year-to-date SKBM sales of $3 million in 2002 represented approximately one-tenth of one percent of estimated 2002 total sales for Alcon worldwide.
Alcon announced that it expects to take an after-tax charge of approximately $15 million in the fourth quarter. This charge includes the estimated costs of the recall and termination of the SKBM product line. Alcon reaffirmed its prior guidance for adjusted earnings per share for the fourth quarter and fiscal year, which excludes the impact of the recall as well as other one-time items reported previously. Given Alcon's diversified portfolio of products and the negligible contribution of the SKBM to total sales, management also confirmed sales and earnings guidance for 2003.