MST ArcDUO 9mm, REF: ARC-0002, single-use, sterile ophthalmic knife, used with Suction Set, Part: 48-1000-01
Reported: November 5, 2025 Initiated: August 20, 2025 #Z-0411-2026
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
Details
- Recalling Firm
- MicroSurgical Technology Inc
- Units Affected
- 8
- Distribution
- US Nationwide distribution in the state of GA.
- Location
- Redmond, WA
Frequently Asked Questions
What product was recalled? ▼
MST ArcDUO 9mm, REF: ARC-0002, single-use, sterile ophthalmic knife, used with Suction Set, Part: 48-1000-01. Recalled by MicroSurgical Technology Inc. Units affected: 8.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 5, 2025. Severity: Moderate. Recall number: Z-0411-2026.
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