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Alcon Research, Ltd. recalls LenSx Laser System. Indicated for use in patients undergoing cataract surgery and refractive surgery.
Recalled May 25, 2016 · FDA recall Z-1688-2016 · Alcon Research
Hazard
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. · FDA Class II
Units
81 units
Sold at
United States, Albania, Australia, Brazil, Chile, Costa Rica, Czech Republic, France, Germany, Greece, Hungary, India, Italy, Romania, Slovakia, Spain, Taiwan, Thailand, Turkey, UAE, Ukraine
Description
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.
Product
LenSx Laser System. Indicated for use in patients undergoing cataract surgery and refractive surgery.
Manufacturer(s)
Alcon Research, Ltd.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →