FDA-Device2016-05-25Class II
LenSx Laser System. Indicated for use in patients undergoing cataract surgery and refractive surgery.
Alcon Research, Ltd.
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.
Sold states
United States, Albania, Australia, Brazil, Chile, Costa Rica, Czech Republic, France, Germany, Greece, Hungary, India, Italy, Romania, Slovakia, Spain, Taiwan, Thailand, Turkey, UAE, Ukraine
Affected count
81 units
Manufactured in
6201 South Fwy, N/A, Fort Worth, TX, United States
Products
LenSx Laser System. Indicated for use in patients undergoing cataract surgery and refractive surgery.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1688-2016Don't want to check this manually?
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