Z-0411-2026Class II

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

Name: Z-0411-2026 MST ArcDUO 9mm, REF: ARC-0002, single-use, sterile ophthalmic knife, used with Suction Set, Part: 48-1000-01
Creator: MicroSurgical Technology Inc
Published: 2025-08-20
License: https://open.fda.gov/license/

MicroSurgical Technology Inc / initiated 2025-08-20 / Open, Classified / root cause: manufacturing process

FDA source

MicroSurgical Technology Inc began a recall of MST ArcDUO 9mm, REF: ARC-0002, single-use, sterile ophthalmic knife, used with Suction Set, Part: 48-1000-01 on 2025-08-20. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0411-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-08-20
Posted: 2025-10-29
Recalling firm: MicroSurgical Technology Inc
Product: MST ArcDUO 9mm, REF: ARC-0002, single-use, sterile ophthalmic knife, used with Suction Set, Part: 48-1000-01
Product code: HNN Knife, Ophthalmic
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
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: On 8/20/2025, a recall notice was sent to a surgery center that was asked to return the affected devices and provide information on affected device disposition. The customer was also asked, if they further distributed affected devices, to notify their customers of the recall For additional information, contact the firm at [email protected]
Quantity in commerce: 8
Distribution: US Nationwide distribution in the state of GA.
Product codes and lots: UDI:00844685014316. Lots: 207552 and 208238

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0411-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0411-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-11-05	2025-10-29

Product code HNN

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)