Reported Jun 14, 2017 · Terminated
Ellex Tango Reflex with slit lamp Laser Ophthalmic In the SLT mode, the device is intended to be used for selective…
Laserex Systems Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Laserex Systems Inc. · 7138 SHADY OAK RD · EDEN PRAIRIE, MN · 55344-3517
Is this the product you have?
- 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.
- Lot codes and dates
- Serial No
TR 0010TR 0095
- Serial No
- Amount recalled
- 83
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.
This product could cause temporary or reversible health problems — stop using it.
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