C-Rex UNO Goniotomy Instrument (Iantrek) – Packaging Integrity (2025)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
C-Rex UNO Microinterventional Goniotomy Instrument. Model Number: CRX-120. Product Description: The C-Rex UNO Microinterventional Goniotomy Instrument is a sterile single use disposable manual surgical instrument used in ophthalmic procedures for ab interno goniotomy and inner wall trabeculotomy.
Brand
Iantrek Inc.
Lot Codes / Batch Numbers
1. Model Number: CRX-120, UDI: +B962CRX1200/$$7351729/16D20250501/14D20260501/Q1$, Lot Number 351729, Lot Number: 351759, Exp date 05/2026.
Products Sold
1. Model Number: CRX-120; UDI: +B962CRX1200/$$7351729/16D20250501/14D20260501/Q1$; Lot Number 351729; Exp date 05/2026. 2. Model Number: CRX-120 UDI: +B962CRX1200/$$7351759/16D20250501/14D20260501/Q1%; Lot Number: 351759; Exp date 05/2026.
Iantrek Inc. is recalling C-Rex UNO Microinterventional Goniotomy Instrument. Model Number: CRX-120. Product Description: Th due to Potential for compromised integrity of the sterile packaging.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential for compromised integrity of the sterile packaging.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026