Cyclopen Cyclodialysis System (Iantrek) – Packaging Integrity (2025)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Iantrek Inc.
Lot Codes / Batch Numbers
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/$$7351795/16D20250601/14D20260601/Q19, Lot Number 351795, Exp date 06/2026.
Products Sold
1. Model Number CP-300; UDI: +B962CP3000/$$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.
Iantrek Inc. is recalling Cyclopen Microinterventional Cyclodialysis System. Model Number: CP-300. Product Description: The C due to Potential for compromised integrity of the sterile packaging.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential for compromised integrity of the sterile packaging.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026