Ellex Tango Reflex with slit lamp Laser Ophthalmic In the SLT mode recalled over fire hazard

Recall date

April 4, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Laserex Systems Inc. recalls Ellex Tango Reflex with slit lamp Laser Ophthalmic In the SLT mode, the device is intended to be used for selective las…

Recall number

Z-2172-2017

FDA classification

Class II

Brand / firm

Laserex Systems Inc.

Sold / distributed

US Distribution

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.