Recall Z-0134-2026— Iantrek Inc.
Class II · Ongoing
Class II FDA medical device recall by Iantrek Inc., initiated 2025-09-06. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Potential for compromised integrity of the sterile packaging..
- Recalling firm
- Iantrek Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-09-06
- Firm location
- Providence, RI, United States
Product description
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.
Reason for recall
Potential for compromised integrity of the sterile packaging.
Data sourced from openFDA. This site is unofficial and independent of the FDA.