Ophthalmic Cannula K7-5840Recalls & reported problems
Katena Products, Inc. · IRRIGATING HAND PIECE, 21GA, 0.5MM · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00841668110393), received between Aug 12, 2021 and Aug 12, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (1 report).
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.
Most reported problems
Device problems
- Device Contamination with Chemical or Other Material1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 12, 2021Device Contamination with Chemical or Other Material
THIS IS A SUPPLEMENTAL / FOLLOW-UP REPORT TO MFR REPORT # 2242450-2021-00002 THE FOLLOWING AE IS THE SAME AS INITIALLY REPORTED. DURING CATARACT EXTRACTION AT THE END OF THE BI-MANUAL I/A PHASE, A FORGEIN OBJECT WAS NOTED TO BE IN THE CAPSULE. THE SURGEON REMOVED THE FOREIGN OBJECT WITH A PAIR OF MICRO-FORCEPS, THEN EXAMINED THE PATIENT'S EYE AND FOUND NO REMNANTS OR SIGNS OF INJURY.
Patient problems: Foreign Body In Patient
MAUDE report 12316769 ↗
Other Cannula, ophthalmic devices
- iTrack Advance iTrack-ADSNova Eye, Inc. · Cannula, Ophthalmic53 reports
- iTrack 250ANova Eye, Inc. · Cannula, Ophthalmic1 recall2 reports
- Vortex Surgical Inc VS0270.25Vortex Surgical, Inc. · Cannula, Ophthalmic1 recall0 reports
- Vortex Surgical Inc VS0200.25Vortex Surgical, Inc. · Cannula, Ophthalmic1 recall0 reports
- Disposable Replacement backflush brush Needles. (23 gauge / 0.6mm) 1281.B1D06D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Cannula, Ophthalmic1 recall0 reports
- Vortex Surgical Inc VS0200.27Vortex Surgical, Inc. · Cannula, Ophthalmic1 recall0 reports
- Vortex Surgical Inc VS0220.25Vortex Surgical, Inc. · Cannula, Ophthalmic1 recall0 reports
- Visitec® 585278Beaver-Visitec International, Inc. · Cannula, Ophthalmic1 recall0 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
- 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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