Integre Pro Laser Ophthalmoscope Systems: Risk of Unintended Laser Emission
Ellex Medical is recalling certain Integre Pro laser ophthalmoscope systems because scattered laser radiation may unintentionally exit the device and be emitted from the objective lens, potentially exposing users' eyes to unexpected laser energy.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device with a potential hazard of unintended laser radiation exposure, but no injuries or illnesses have been reported. The hazard is theoretical, based on scattered radiation that may unintentionally exit the device.
Plain-English summary
Ellex Medical Pty Ltd. is recalling certain Integre Pro laser ophthalmoscope systems: the Integre Pro Yellow LP561, Integre Pro Yellow LP6RY, Integre Pro Scan Green LP6G, Integre Pro Green LP5532 Spare, Optics Bench V2, and L2G/LP6G. Fifty-seven systems have been distributed worldwide, including 6 units to the United States.
When used as a Laser-Indirect-Ophthalmoscope (LIO) delivery device, scattered laser radiation inside the laser cavity system may unintentionally exit through the Slit Lamp output port and be emitted from the objective lens when the laser is fired. This unintended emission could expose users to unexpected laser radiation.
Users of affected systems should be aware of this potential hazard and its implications for the safe use of these devices.
The recalled product
- Product
- Integre Pro Yellow LP561, Integre Pro Yellow LP6RY, Integre Pro Scan Green LP6G, Integre Pro Green LP5532 Spare, Optics Bench V2, L2G/LP6G
- Manufacturer
- Ellex Medical Pty Ltd.
- Hazard
- laser-radiation
- unintended-emission
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 (6)
- Serial Nos.
- UDI IPY0374
- (01) 0 9342395 00012 0 ISRY0242
- (01) 0 9342395 00015 1 ISG0370
- (01) 0 9342395 00024 3 IPG0539
- (01) 0 9342395 00009 0 BG1190
Distribution
Distributed nationwide across the United States.
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