Z-0411-2026 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- November 5, 2025
- Initiation Date
- August 20, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8
Product Description
MST ArcDUO 9mm, REF: ARC-0002, single-use, sterile ophthalmic knife, used with Suction Set, Part: 48-1000-01
Reason for Recall
An ophthalmic knife has a suction set (not direct patient-contacting), which contains springs contaminated with an unidentified residue that may potentially cause eye irritation
Distribution Pattern
US Nationwide distribution in the state of GA.
Code Information
UDI:00844685014316. Lots: 207552 and 208238