FDA recall Z-0134-2026

Iantrek Inc. · Class II · device

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 for recall

Potential for compromised integrity of the sterile packaging.

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.

Key facts

Status
Ongoing
Initiation date
2025-09-06
Report date
2025-10-22
Voluntary/Mandated
Voluntary: Firm initiated
Location
Providence, RI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0134-2026