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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

D.O.R.C. Dutch Opthalmic Research Center Intl B.V.: Directional Laser Probes Recalled for Difficulty Retracting or Directing Tips

Agency Publication Date: March 21, 2024
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Summary

D.O.R.C. Dutch Ophthalmic Research Center is recalling approximately 288 units of Directional Laser Probes with Alcon / Lumenis connectors. These medical devices are used in ophthalmic surgery and include 23, 25, and 27 gauge models. The recall was initiated because surgeons may experience significant difficulty extending or retracting the laser fiber, and in some cases, may not be able to direct the laser fiber tip precisely during surgical procedures. Consumers should contact their healthcare provider or the manufacturer regarding these affected devices sold across the United States and Puerto Rico.

Risk

The mechanical failure of the probe's fiber tip can lead to surgical delays or difficulty in precisely targeting laser energy during eye surgery, potentially increasing the risk of unintended tissue damage or surgical complications.

What You Should Do

  1. Identify your product by checking the packaging for Product Numbers 7223.ALC (23 gauge), 7225.ALC (25 gauge), or 7227.ALC (27 gauge).
  2. Verify the UDI/DI numbers on the label: 08717872014173 (23g), 08717872014203 (25g), or 08717872031897 (27g).
  3. Check the lot number on the device packaging; all lots starting with a number between 2470 and 18705 are affected by this recall.
  4. If you have an affected probe, contact D.O.R.C. Dutch Ophthalmic Research Center Intl B.V. at their headquarters or your local distributor to arrange for the return or replacement of the devices.
  5. Healthcare providers should immediately stop using these specific lots and isolate any remaining inventory to prevent accidental use in surgery.
  6. For more information or to report concerns, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Contact manufacturer for instructions

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Directional Laser Probe with Alcon / Lumenis connector (23 gauge / 0.6 mm)
Model / REF:
7223.ALC
UDI/DI: 08717872014173
Lot Numbers:
All lots starting with a number between 2470 and 18705
Product: Directional Laser Probe with Alcon / Lumenis connector (25 gauge / 0.5 mm)
Model / REF:
7225.ALC
UDI/DI: 08717872014203
Lot Numbers:
All lots starting with a number between 2470 and 18705
Product: Directional Laser Probe with Alcon / Lumenis connector (27 gauge / 0.4 mm)
Model / REF:
7227.ALC
UDI/DI: 08717872031897
Lot Numbers:
All lots starting with a number between 2470 and 18705

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94022
Status: Active
Manufacturer: D.O.R.C. Dutch Opthalmic Research Center Intl B.V.
Sold By: Authorized medical distributors
Manufactured In: Netherlands
Units Affected: 3 products (14 boxes x 6 units per box = 84 units; 21 boxes x 6 units each = 126 units; 13 boxes x 6 units per box = 78 units)
Distributed To: Arizona, Colorado, Florida, Indiana, Maryland, North Carolina, New York, Ohio, South Carolina, Texas, Puerto Rico

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.