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.
Reported: October 22, 2025 Initiated: September 6, 2025 #Z-0134-2026
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.
Details
- Recalling Firm
- Iantrek Inc.
- Units Affected
- 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.
- Location
- Providence, RI
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Iantrek Inc.. Units affected: 1,262 units.
Why was this product recalled? ▼
Potential for compromised integrity of the sterile packaging.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 22, 2025. Severity: Moderate. Recall number: Z-0134-2026.
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