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CARDINAL HEALTH SEY69PHKO1Recalls & reported problems

Cardinal Health 200, LLC · BMOB PHACO PACK · Class 2

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 10888439359886), received between Apr 26, 2019 and Apr 26, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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

  • Patient-Device Incompatibility1

Patient problems

  • Skin Tears1

Recent adverse event reports

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

  • InjuryApr 26, 2019Patient-Device Incompatibility

    THE CUSTOMER REPORTED THAT THE ADHESIVE FROM THE OPTHALMIC DRAPE (B)(4) FROM THE PHACOEMULSIFICATION PACK/ SEY69PHKO1 CAUSED SMALL SKIN TEARS AROUND THE PATIENT¿S EYE DURING CATARACT SURGERY. THE PATIENT WAS TREATED WITH MAXITROL OINTMENT AND WAS DOING OK. NO PATIENT DEMOGRAPHICS WERE PROVIDED.

    Patient problems: Skin Tears

    MAUDE report 8556902 ↗

Other Eye tray devices

All Eye tray devices →

Sources and updates

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