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MicroSurgical Technology Inc: MST ArcDUO 9mm, REF: ARC-0002, single-use, sterile ophthalmic knife, used with Suction Set, Part: 48-1000-01

Medical DevicesSource: FDA (device) · Date: 2025-11-05

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
MicroSurgical Technology Inc
Product
MST ArcDUO 9mm, REF: ARC-0002, single-use, sterile ophthalmic knife, used with Suction Set, Part: 48-1000-01
Reason / 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
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide distribution in the state of GA.
Recall initiated
2025-08-20
Code info
UDI:00844685014316. Lots: 207552 and 208238
Product quantity
8
Voluntary mandated
Voluntary: Firm initiated
City
Redmond
State
WA
Country
United States
Event id
97470
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