FDA Device recall Z-0134-2026
Cyclopen Microinterventional Cyclodialysis System
- FDA Device
- Class II
- ongoing
- Published 2025-10-22
On 2025-10-22 the FDA classified a Class II recall of Cyclopen Microinterventional Cyclodialysis System by Iantrek, citing potential for compromised integrity of the sterile packaging.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0134-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-09-06 |
| Published | 2025-10-22 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Iantrek |
| Distribution | US |
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.
Identifiers
| code_info | 1. Model Number CP-300; UDI: +B962CP3000/$$7351645/16D20250201/14D20260201/Q1_; Lot Number: 351645; Exp date 02/2026.…1. Model Number CP-300; UDI: +B962CP3000/$$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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0134-2026%22
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