Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Ellex Tango Reflex with slit lamp Laser Ophthalmic In the SLT mode Recalled by Laserex Systems Inc. Due to It was discovered the unit produced a laser...
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 Laserex Systems Inc. directly.
Affected Products
Ellex Tango Reflex with slit lamp Laser Ophthalmic In the SLT mode, the device is intended to be used for selective laser trabeculoplasty (ST) operations (laser trabeculoplasty for primary open angle glaucoma). In the VAG mode it is intended to be used to perform procedures requiring the rupture of tissue in the eye for Iridotomy and Iridectomy, Posterior capsulotomy and Posterior membranectomy.
Quantity: 83
Why Was This Recalled?
It was discovered the unit produced a laser emission without pressing the fire button when the slit-lamp was driven to its lowest position prior to use on any patient.
Where Was This Sold?
US Distribution
About Laserex Systems Inc.
Laserex Systems Inc. has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report