CARDINAL HEALTH SEY54CTPHLRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10887488840987), received between Jan 5, 2018 and Jan 5, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Material Disintegration” (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.

• InjuryJan 5, 2018Material Disintegration

  THE CUSTOMER STATED THAT A BLUE FIBER REPORTEDLY FROM THE CATARACT PACK/SEY54CTPHL WAS FOUND IN THE PATIENT¿S EYE AFTER CATARACT SURGERY. THE COMPONENT SOURCE WAS UNKNOWN BUT THE CUSTOMER FELT THE LINTING WAS FROM THE GOWN. A DRAPE AND BACK TABLE COVER WERE ALSO IN THIS KIT, ALTHOUGH THE CUSTOMER HAD INDICATED THEY BELIEVED THE FIBERS WERE COMING FROM THE GOWNS. THE PATIENT DID GO BACK TO SURGERY TO HAVE THE FIBER REMOVED. THERE WAS NO INJURY TO THE PATIENT AND THE PATIENT WAS DOING WELL.

  Patient problems: Foreign Body In Patient

  MAUDE report 7168861 ↗