FDASeptember 6, 2025device

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, b...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Potential for compromised integrity of the sterile packaging.

What to do

FDA enforcement status: Ongoing

Brands named

iantrek

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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