Class II U.S. Food and Drug Administration

Iantrek Inc. Cyclopen Microinterventional Cyclodialysis System recall: Potential for compromised integrity of the sterile packaging

Recall published 1+ years ago

Potential for compromised integrity of the sterile packaging.

The hazard: Sterility or particulate concern

Particulate matter or a sterility failure prompted this notice, the most common reason injectable and ophthalmic products are withdrawn.

What the notice says: Potential for compromised integrity of the sterile packaging.

Why it matters: The product was made or packaged in conditions that cannot assure sterility, or visible particles were found in it. For anything injected, infused or used in the eye, that is a direct route for contamination into the body.

Symptoms and when to call a doctor

Watch for fever, chills, pain, redness, swelling or discharge at an injection site, and for a red, painful or suddenly blurred eye after using an eye product. Any of these needs same-day medical attention. Do not wait to see whether it settles, and tell the clinician which product and lot you used so it can be reported against the recall.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
Z-0134-2026
Published
October 22, 2025
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Iantrek Inc.
Product type
Medical devices
Units affected
1,262 units
Distribution
Nationwide
Made in
United States
Lot / code info
1. Model Number CP-300; UDI: +B962CP3000/$$7351645/16D20250201/14D20260201/Q1_; Lot Number: 351645; Exp date 02/2026. 2. Model Number CP-300; UDI: +B962CP3000/$$7351726/16D20250501/14D20260501/Q11; Lot Number 351726; Exp date 05/2026. 3. Model Number CP-300; UDI: +B962CP3000/$$7351795/16D20250601/14D20260601/Q19; Lot Number 351795; Exp date 06/2026.

Products covered by this recall

Cyclopen Microinterventional Cyclodialysis System. Model Number: CP-300. Product Description: The CycloPen Microinterventional Cyclodialysis device is a manual surgical instrument used for the ab-interno construction or modification of a cyclodialysis, followed by delivery of viscous materials, bio-tissue/allograft, or other materials to reinforce and maintain the cleft.

Check your product

The notice names 9 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 351645
  • 351726
  • 351795

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • 02
  • 05
  • 06
  • 2026. — 1
  • 262 units

Model or item number

On the rating label, the box or the instruction sheet.

  • CP-300

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Sterility

Iantrek Inc. — Particulate matter or a sterility failure prompted this notice, the most common reason injectable and ophthalmic products are withdrawn.

  1. Stop using the affected lot and check the lot number on your own carton or vial against the codes listed above.
  2. Call your prescriber or pharmacy today about a replacement from an unaffected lot — do not simply skip doses of a medicine you depend on.
  3. If you are a clinic or pharmacy, quarantine the stock and work it through your usual recall log.
  4. Report any infection or reaction you think the product caused to FDA MedWatch.

What the company owes you

A recalled medicine is the manufacturer’s cost to carry, not yours or your pharmacist’s.

  • The purchase price or co-pay is refundable, and so is the cost of returning the product if they ask you to ship it.
  • Ask the pharmacy to handle the claim where they can — they process recall returns in bulk and it saves you the correspondence.
  • Keep the carton, the leaflet and the pharmacy label together until the claim is closed.
  • Costs beyond the price of the medicine need to go to the company directly, in writing, with the recall number quoted.

Company contact: Iantrek Inc. — 216 Weybosset St Ste 2, Providence, RI, 02903-3734

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Iantrek Inc. medical devices recalled?

Potential for compromised integrity of the sterile packaging. Potential for compromised integrity of the sterile packaging.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code 351645, 351726, 351795; best-by date 02 or 05; model number CP-300. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Stop using the affected lot and check the lot number on your own carton or vial against the codes listed above.

Can I get my money back?

The purchase price or co-pay is refundable, and so is the cost of returning the product if they ask you to ship it.

Where was the recalled product sold?

It was distributed nationwide.

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