CARDINAL HEALTH KAI3BCTKPBRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10887488446660), received between Apr 18, 2018 and Apr 18, 2018 — 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

Recent adverse event reports

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

• InjuryApr 18, 2018Device Contamination with Chemical or Other Material

  BASED ON THE CUSTOMER INFORMATION SUBMITTED A BLUE FILAMENT/LINT REPORTEDLY FROM THE CATARACT PACK/ KAI3BCTKPB WAS FOUND WITHIN A PATIENT¿S EYE AFTER CATARACT SURGERY. THE PATIENT WAS RETURNED TO THE OPERATING ROOM TO HAVE THE FILAMENT REMOVED. BECAUSE IT WAS EMBEDDED DEEPLY THE IRIS CAME OUT WHEN THE BLUE FILAMENT WAS REMOVED. THE PATIENT HAD INCREASED INFLAMMATION SECONDARY TO THE PRESENCE OF THE FILAMENT AND ITS REMOVAL. THE PATIENT IS NOW STABLE WITH NO ISSUES.

  Patient problems: Foreign Body In Patient; Inflammation

  MAUDE report 7441088 ↗