Severity
Low
LowClass IIITerminated
FDA Devices recall · Reported July 15, 2015
Lombart 90D Clear with case Visualization during diagnosis and laser therapy of the human retina (fundus) using a slit lamp.
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.
Volk Optical Inc recalled Lombart 90D Clear with case Visualization during diagnosis and laser therapy of the huma… — a low-severity action.
Lombart 90D Clear with case Visualization during diagnosis and laser therapy of the huma… was recalled by Volk Optical Inc in July 15, 2015. Reason: Mislabeling. The incorrect lot number was engraved on the anodized aluminum ring. The correct lot number is…. Check the official notice for the remedy. Verify recall #Z-2055-2015 with the FDA Devices before acting.
The recall
Volk Optical Inc issued this low-severity FDA Devices recall — Mislabeling. The incorrect lot number was engraved on the anodized aluminum ring. The correct lot number is….
- Low
- severity level
- 78 units
- affected scope
- Class III
- classification
- July 15, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2055-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2055-2015) was formally reported on July 15, 2015, with the manufacturer initiating the action on February 27, 2015. It is classified under Low severity (Class III), with a current status of Terminated. Volk Optical Inc is listed as the recalling firm, operating out of Mentor, OH. Federal records list the affected scope as 78 units.
The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: Distribution to VA only. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices — clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category — 40,409 medical devices recalls on record
Where this recall sits in the database
Of 100,165 recalls in the database, 23,668 are high severity, 72,097 moderate, and 4,400 low. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger — we do not rank products by risk from raw recall volume.
Affected scope
78 units
Related Recalls
6
6 from same agency
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | Z-2055-2015 |
| Date reported | July 15, 2015 |
| Date initiated | February 27, 2015 |
| Recalling firm | Volk Optical Inc |
| Firm location | Mentor, OH |
| Affected scope | 78 units |
| Distribution | Distribution to VA only |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2055-2015) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting — recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Lombart 90D Clear with case Visualization during diagnosis and laser therapy of the human retina (fundus) using a slit lamp.. Recalled by Volk Optical Inc. Units affected: 78 units.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Devices on July 15, 2015. Severity: Low. Recall number: Z-2055-2015.
Where was the recalled product distributed? ▼
Distribution: Distribution to VA only.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2055-2015) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Other recalls in the same product category — useful for spotting patterns across the same defect class or manufacturer.
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Data Sources
Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported July 15, 2015.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records — no number is typed in by an editor. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of June 2026.