Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

LenSx Laser System. Indicated for use in patients undergoing cataract Recalled by Alcon Research, Ltd. Due to Alcon is conducting a voluntary recall of all...

Date: April 14, 2016
Company: Alcon Research, Ltd.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Alcon Research, Ltd. directly.

Affected Products

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

Quantity: 81 units

Why Was This 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.

Where Was This Sold?

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

About Alcon Research, Ltd.

Alcon Research, Ltd. has 26 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report