CLASS II ONGOING Device recall · Reported 5 Jul 2023 · FDA Enforcement Report
Integre Pro Yellow LP561, Integre Pro Yellow LP6RY recalled
Ellex Medical is recalling Integre Pro Yellow LP561, Integre Pro Yellow LP6RY, Integre Pro Scan Green LP6G, Integre, distributed nationwide in the US. The recall was initiated on 16 Mar 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1971-2023
- FDA event ID
- 92532
- Recalling firm
- Ellex Medical, Mawson Lakes, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 16 Mar 2023
- FDA classified
- 27 Jun 2023
- Reported
- 5 Jul 2023
- Type
- FDA Mandated
- Customers notified by
- N/A
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 16 Mar 2023 | Recall initiated by company | |
| 27 Jun 2023 | Classified by FDA | +103 days |
| 5 Jul 2023 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Product as listed by the FDA
Integre Pro Yellow LP561, Integre Pro Yellow LP6RY, Integre Pro Scan Green LP6G, Integre Pro Green LP5532 Spare, Optics Bench V2, L2G/LP6G
Where it was distributed
US nationwide/ Worldwide Distribution
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
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
Where was it sold?
US nationwide/ Worldwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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