FDA recall Z-0135-2026

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.

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-0135-2026