FDA Device recall Z-2055-2015
Lombart 90D Clear with case Visualization during diagnosis and laser therapy of the human retina (fundus) using a slit lamp
- FDA Device
- Class III
- terminated
- Published 2015-07-15
On 2015-07-15 the FDA classified a Class III recall of Lombart 90D Clear with case Visualization during diagnosis and laser therapy of the human retina (fundus) using a slit lamp by Volk Optical, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2055-2015 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2015-02-27 |
| Published | 2015-07-15 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Volk Optical |
| Distribution | VA |
Product
Lombart 90D Clear with case Visualization during diagnosis and laser therapy of the human retina (fundus) using a slit lamp.
Reason
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.
Identifiers
| code_info | Model: L90C, Lot: BE03356, |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2055-2015%22
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