FDA-Device2025-11-05Class IIPROCESSING DEFECT
MST ArcDUO 9mm, REF: ARC-0002, single-use, sterile ophthalmic knife, used with Suction Set, Part: 48-1000-01
Hazard
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
Who it affects
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution in the state of GA.
Affected count
8
Manufactured in
8415 154th Ave Ne, N/A, Redmond, WA, United States
Products
MST ArcDUO 9mm, REF: ARC-0002, single-use, sterile ophthalmic knife, used with Suction Set, Part: 48-1000-01
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0411-2026Don't want to check this manually?
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