Iantrek Inc. recalls Cyclopen Microinterventional Cyclodialysis System. Model Number: CP-300. Product Des…

Potential for compromised integrity of the sterile packaging.

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.

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.

• FDA enforcement recordOfficial FDA database entry for Z-0134-2026
• FDA device classification · HMXOfficial FDA classification for this device type
• CFR regulation · 21 CFR 886.4350The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Iantrek Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.