Ophthalmic Cannula K7-4920Recalls & reported problems
Katena Products, Inc. · JENSEN CAPSULE POLISHER 25GA · 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 00841668109410), received between Feb 28, 2022 and Feb 28, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Corroded” (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
- Corroded1
Patient problems
- Capsular Bag Tear1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 28, 2022Corroded
DURING CATARACT SURGERY THE SURGEON REPORTED AN IMMEDIATE CAPSULAR TEAR WHEN THE OLIVE TIP OF THE JENSEN CAPSULE POLISHER TOUCHED THE CAPSULE, THE SURGEON NOTED CORROSION (OXIDATION) SEEN ON THE POLISHER. THE TYPE OF INJURY SUSTAINED WAS A CAPSULE TEAR WITH IMMEDIATE ACTION BEING ANTERIOR VITRECTOMY WITH SULCUS LENS / OPTIC RAPTURE RESULTING IN PROLONGED SURGERY. THE ORIGINAL REPORT WAS ONE EVENT, SUBSEQUENTLY, THE USER FACILITY INDICATED THAT A SIMILAR INCIDENT OCCURRED TO TWO DIFFERENT PATIENTS. THE PATIENTS ARE DOING WELL ONCE HEALED.
Patient problems: Capsular Bag Tear
MAUDE report 13625338 ↗
Other Cannula, ophthalmic devices
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- 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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