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Oph.Spatula 05-4036Recalls & reported problems

Katena Products, Inc. · Fine-Nagahara Chopper, RH Dom., Titanium · Class 1

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 00852979003083), received between Sep 10, 2021 and Sep 10, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Break1

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.

  • InjurySep 10, 2021Break; Break

    DURING LEFT EYE CATARACT REMOVAL WITH INTRAOCULAR LENS IMPLANT - PHACO, THE INSTRUMENT TIP BROKE OFF WHEN REMOVING IT FROM THE EYE. THIS WAS NOTED WHEN THE INSTRUMENT WAS REINSERTED BACK INTO THE EYE AND THE TIP PIECE WAS SEEN TO BE MISSING. THE PIECE WAS FOUND IN THE BACK OF THE CAPSULE, THE SURGEON REMOVED IT USING GRASPERS WITH NO APPARENT INJURY TO THE PATIENT'S EYE PER THE CST AND SURGEON. THE PATIENT WAS DISCHARGED HOME FROM PHASE 2 RECOVERY PER ROUTINE PLAN.

    Patient problems: Foreign Body In Patient

    MAUDE report 12456351 ↗

Other Spatula, ophthalmic devices

All Spatula, ophthalmic devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.