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.
Reported: October 22, 2025 Initiated: September 6, 2025 #Z-0135-2026
Product Description
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.
Reason for Recall
Potential for compromised integrity of the sterile packaging.
Details
- Recalling Firm
- Iantrek Inc.
- Units Affected
- 198
- 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? ▼
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.. Recalled by Iantrek Inc.. Units affected: 198.
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-0135-2026.
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