Lombart 90D Clear with case Visualization during diagnosis and laser… — Class III medical device recall Z-2055-2015
Terminated recall by Volk Optical Inc, reported 2015-07-15. Mislabeling. The incorrect lot number was engraved on the anodized aluminum ring. The correct lot number is BE
| Recall number | Z-2055-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Volk Optical Inc, Mentor, OH, United States |
| Recall initiated | 2015-02-27 |
| Classified | 2015-07-09 |
| Reported by FDA | 2015-07-15 |
| Terminated | 2016-02-04 |
| Quantity | 78 units |
| Reason classes | labeling |
| Lot numbers | BE03356 |
| Model numbers | L90C |
Product
Lombart 90D Clear with case Visualization during diagnosis and laser therapy of the human retina (fundus) using a slit lamp.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2055-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.