Alcon Research, Ltd. recalls LenSx Laser System. Indicated for use in patients undergoing cataract surgery and refractive surgery.

Recall date

April 14, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1688-2016

FDA classification

Class II

Brand / firm

Alcon Research, Ltd.

Sold / distributed

United States, Albania, Australia, Brazil, Chile, Costa Rica, Czech Republic, France, Germany, Greece, Hungary, India, Italy, Romania, Slovakia, Spain, Taiwan, Thailand, Turkey, UAE, Ukraine

Why it was recalled

Alcon is conducting a voluntary recall of all LenSx Lasers with Corneal Flap Capability after receiving reports concerning incomplete corneal flap creation, which manifests as an un-dissected area(s) within the side cut.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

LenSx Laser System. Indicated for use in patients undergoing cataract surgery and refractive surgery.