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FDAApril 14, 2016device

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

Official recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Terminated

Brands named

alcon researchalcon

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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LenSx Laser System. Indicated for use in patients undergoing cataract surgery and refractive surgery. — Recall Details · AllClear