Recall Z-0134-2026

Iantrek Inc. · initiated September 6, 2025

Class II Open, Classified

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

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.

Codes / lots: 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.

Reason for recall

Potential for compromised integrity of the sterile packaging.

FDA-determined cause: Process control

Action taken

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.

Details

Recall number: Z-0134-2026
Initiated: September 6, 2025
Posted by FDA: October 10, 2025
Product code: HMX – Cannula, Ophthalmic
Quantity: 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.
Recalling firm: Iantrek Inc., Providence, RI

Official FDA recall record

Other products in the same recall event

Recall	Product	Initiated
Z-0135-2026 Class II	C-Rex UNO Microinterventional Goniotomy Instrument. Model Number: CRX-120. Product…Potential for compromised integrity of the sterile packaging.	09/06/2025Open, Classified