Laserex Systems Inc.: Medical Device Recall in 2017 - (Recall #: Z-2172-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: April 4, 2017

Date Posted: June 14, 2017

Recall Number: Z-2172-2017

Event ID: 77170

Reason for Recall:

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.

Status: Terminated

Product Quantity: 83

Code Information:

Serial No: TR 0010, TR 0095

Distribution Pattern:

US Distribution

Voluntary or Mandated:

FDA Mandated