CLASS III Device recall · Reported 15 Jul 2015 · FDA Enforcement Report
Lombart 90D Clear with case Visualization during diagnosis recalled
Volk Optical is recalling Lombart 90D Clear with case Visualization during diagnosis and laser therapy of the human, distributed in Virginia. The recall was initiated on 27 Feb 2015 and the FDA has classified it as Class III.
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-2055-2015
- FDA event ID
- 71048
- Recalling firm
- Volk Optical, Mentor, OH
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 27 Feb 2015
- FDA classified
- 9 Jul 2015
- Reported
- 15 Jul 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Other Medical Devices
Timeline
| 27 Feb 2015 | Recall initiated by company | |
| 9 Jul 2015 | Classified by FDA | +132 days |
| 15 Jul 2015 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Mislabeling. The incorrect lot number was engraved on the anodized aluminum ring. The correct lot number is BE03356; however, BD03356 was engraved on the ring in error.
Product as listed by the FDA
Lombart 90D Clear with case Visualization during diagnosis and laser therapy of the human retina (fundus) using a slit lamp.
Where it was distributed
Distribution to VA only
Questions about this recall
Is Lombart 90D Clear with case Visualization during diagnosis and laser therapy of the human recalled?
Yes. Volk Optical recalled Lombart 90D Clear with case Visualization during diagnosis and laser therapy of the human on 27 Feb 2015. The recall is Class III and its status is Terminated. Recall number Z-2055-2015.
Why was it recalled?
Mislabeling. The incorrect lot number was engraved on the anodized aluminum ring. The correct lot number is BE03356; however, BD03356 was engraved on the ring in error.
Which lots are affected?
Model: L90C, Lot: BE03356,
Where was it sold?
Distribution to VA only
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 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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