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Oph.Spatula 08-14502Recalls & reported problems

Katena Products, Inc. · Nagahara Phaco Chopper, RH Dominant · 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 00852979003304), received between Apr 9, 2021 and Apr 9, 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

  • Break1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryApr 9, 2021Break; Break

    DURING A CATARACT EXTRACTION WITH IOL IMPLANT PROCEDURE THE TIP OF THE NAGAHARA PHACO CHOPPER BROKE OFF IN THE PATIENT'S EYE. THE SURGEON IMMEDIATELY RETRIEVED THE TIP WITH NO COMPLICATIONS AND NO INJURY TO THE PATIENT WAS REPORTED. NO PROLONGED SURGERY OR HOSPITALIZATION WAS REQUIRED. THE PATIENT'S POST-OP VISIT THE FOLLOWING DAY WENT WELL, NO COMPLAINTS OR COMPLICATIONS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11641011 ↗

Other Spatula, ophthalmic devices

All Spatula, ophthalmic devices →

Sources and updates

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