Z-0134-2026Class II

Cyclopen Microinterventional Cyclodialysis System. Model Number: CP-300. Product Description: The CycloPen...

Name: Z-0134-2026 Cyclopen Microinterventional Cyclodialysis System. Model Number: CP-300. Product Description: The CycloPen...
Creator: Iantrek Inc.
Published: 2025-09-06
License: https://open.fda.gov/license/

Iantrek Inc. / initiated 2025-09-06 / Open, Classified / root cause: manufacturing process

FDA source

Iantrek Inc. began a recall of Cyclopen Microinterventional Cyclodialysis System. Model Number: CP-300. Product Description: The CycloPen Microinterventional Cyclodialysis device is a manual... on 2025-09-06. FDA classified it as Class II and gives the reason as "Potential for compromised integrity of the sterile packaging". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0134-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-09-06
Posted: 2025-10-10
Recalling firm: Iantrek Inc.
Product: 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.
Product code: HMX Cannula, Ophthalmic
Reason for recall: Potential for compromised integrity of the sterile packaging.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Iantrek notified consignees on 09/06/2025 via email. Consignees were instructed to immediately remove and quarantine all affected units to prevent their use, notify personnel or customers if affected units were forwarded to other facilities. Consignees may also alternatively provide Iantrek with contact information so that they can notify them on the customer's behalf. An Iantrek representative will be contacting each consignee immediately to help facilitate removal, return and replacement of affected units. They will arrange to have replacement product shipped to consignees at no cost.
Quantity in commerce: 1,262 units
Distribution: US Nationwide distribution in the states of AL, AZ, CA, CT, DE, FL, GA, ID, IL, MD, MI, MN, MO, MS, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0134-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0134-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-22	2025-10-10
Z-0135-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-22	2025-10-10

Product code HMX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)