Laserex Systems Recalls Ellex Tango Reflex Laser Ophthalmic Units
Laserex Systems Inc. is recalling 83 Ellex Tango Reflex laser ophthalmic units because they may emit laser energy without the fire button being pressed.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves an unintended laser emission from an ophthalmic device, which poses a significant risk of injury to the eye.
Plain-English summary
Laserex Systems Inc. is recalling 83 units of the Ellex Tango Reflex with slit lamp Laser Ophthalmic device. The recall covers units with serial numbers TR 0010 through TR 0095 that were distributed in the United States.
The recall was initiated because it was discovered that the units could produce a laser emission without the operator pressing the fire button. This malfunction occurred when the slit-lamp was driven to its lowest position prior to use on a patient. The device is intended for selective laser trabeculoplasty and procedures requiring the rupture of tissue in the eye.
Healthcare providers and consumers should stop using the affected devices immediately. Laserex Systems Inc. is the recalling firm responsible for managing the recall.
The recalled product
- 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…
- Manufacturer
- Laserex Systems Inc.
- Affected units
- 83
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Serial No: TR 0010
- TR 0095
Distribution
Distribution scope not specified by the agency.
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