Recall Z-2172-2017— Laserex Systems Inc.
Class II · Terminated
Class II FDA medical device recall by Laserex Systems Inc., initiated 2017-04-04, terminated 2017-07-31. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: 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..
- Recalling firm
- Laserex Systems Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-04-04
- Terminated
- 2017-07-31
- Firm location
- EDEN PRAIRIE, MN, United States
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.