ArcDuo, Guarded Depth Paired Ophthalmic Knife 9mm ARC-0002Recalls & reported problems
Microsurgical Technology, Inc. · The ArcDUO device is a single-use, sterile ophthalmic knife that is intended to make controlled depth paired arcuate incisions on the cornea at or near the limbus. · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00844685014316), received between Apr 14, 2026 and Apr 14, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Use of Device Problem” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Recalls naming this device
- Aug 20, 2025Class IIOpen, Classified
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
Z-0411-2026 · Root cause: Material/Component Contamination · Recall details · FDA record ↗
Most reported problems
Device problems
- Use of Device Problem1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 14, 2026Use of Device Problem
PROCEDURES AND PATIENTS WERE SCHEDULED WITH DR. (B)(6) AND TOOK PLACE AT SPECIALTY IN (B)(6). DURING THE SECOND DEMO, SUCTION WAS SUCCESSFUL. DR. (B)(6) PLACED THE BLADES CORRECTLY AND PERFORMED A FIRST TURN. REMOVED THE BLADES AND THE DEVICE. ONLY ONE ARC WAS SUCCESSFUL, UPON WHICH DR. (B)(6) WENT BACK TO PERFORM A SECOND PROCEDURE WITHOUT REMOVING THE FIRST BLADE ON THE SIDE OF THE SUCCESSFUL ARC. AFTER THE SECOND ATTEMPT THE FIRST ARC APPEARED UNCHANGED, AND THE SECOND ARC FAILED TO MATERIALIZE. DR. (B)(6) RESUMED THE CASE AND WENT INTO PHACO. AS FLUIDICS STARTED LEAKING OUT OF THE ARC DR. (B)(6) REALIZED HE HAD PERFORATED THE CORNEA. HE FINISHED HIS PHACO CASE AND SUTURED THE ARC WITH 4 STITCHES.
Patient problems: Insufficient Information
MAUDE report 24879883 ↗
Other Knife, Ophthalmic devices
- ClearCut® 8065921541Alcon Laboratories, Inc. · Knife, ophthalmic2 recalls215 reports
- ClearCut®; Intrepid 8065992445Alcon Laboratories, Inc. · Knife, ophthalmic2 recalls170 reports
- ClearCut®; Intrepid 8065982465Alcon Laboratories, Inc. · Knife, ophthalmic1 recall153 reports
- V-Lance 8065912001Alcon Laboratories, Inc. · Knife, ophthalmic2 recalls68 reports
- ClearCut® 8065771541Alcon Laboratories, Inc. · Knife, ophthalmic2 recalls38 reports
- ClearCut® 8065771540Alcon Laboratories, Inc. · Knife, ophthalmic2 recalls30 reports
- ClearCut®; Intrepid 8065772465Alcon Laboratories, Inc. · Knife, ophthalmic2 recalls7 reports
- ClearCut®; Intrepid 8065982265Alcon Laboratories, Inc. · Knife, ophthalmic104 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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