Ellex Medical recalls Integre Pro Yellow and Green laser ophthalmoscopes due to risk of scattered laser beams exiting the device during use, potentially causing eye injury.
When using a Laser-Indirect-Ophthalmoscope (LIO) as the delivery device, a scattered laser beam inside the laser cavity system may unintentionally exit through the Slit Lamp output port (SDS) and get emitted from the Objective Lens when the laser is fired.
Ellex Medical is recalling several models of Integre Pro laser ophthalmoscopes because they can emit scattered laser beams through the slit lamp output port during use. This hazard could cause eye injury if someone is exposed to the laser beam.
When the laser is fired, scattered laser beams can exit through the slit lamp output port and be emitted from the objective lens. This can happen even when the device is being used correctly, potentially causing eye injury if someone is exposed to the laser beam.
Ophthalmologists and other medical professionals who use these laser ophthalmoscopes for eye examinations are most at risk. Patients using these devices during exams may also be exposed.
Check for the Integre Pro Yellow LP561, Integre Pro Yellow LP6RY, Integre Pro Scan Green LP6G, Integre Pro Green LP5532 Spare, or Optics Bench V2 models. These products were sold with specific serial numbers listed in the recall notice.
Look for the serial number on the device or its packaging to confirm if it's in the recalled list.
Reach out to Ellex Medical directly for guidance on next steps if you have a recalled device.
Integre Pro Yellow LP561, Integre Pro Yellow LP6RY, Integre Pro Scan Green LP6G, Integre Pro Green LP5532 Spare, and Optics Bench V2 models.
The recall notice does not mention a specific fix or remedy for this issue.
Check the serial number against the list provided in the recall notice: 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.
We’ve drafted a message you can send Ellex Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1971-2023 — Ellex Medical Ellex Medical Hello, I own a Ellex Medical that is covered by recall Z-1971-2023 from Ellex Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
