CARDINAL HEALTH SEY54CPCANRecalls & reported problems
Cardinal Health 200, LLC · BASIC CATARACT OPO70 PACK · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10887488555294), received between May 30, 2018 and May 30, 2018 — classified as 2 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).
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
- Insufficient Device Problem Information2
Patient problems
- Rash2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMay 30, 2018Insufficient Device Problem Information
THE CUSTOMER STATED THAT ONE OF THEIR PATIENTS DEVELOPED A RASH TO THE EYES AND SURROUNDING AREA FOLLOWING AN OPHTHALMIC SURGERY. THE COMPONENT SOURCE WAS UNKNOWN BUT THE CUSTOMER FELT IT COULD POSSIBLY BE FROM THE TRANSPARENT DRESSING TD-24CNS2 FROM THE BASIC CATARACT PACK/ SEY54CPCAN. THE PATIENT WAS TREATED WITH PREDNISOLONE ACETATE 1% 1GTT BOTH EYES, TOPICAL BACITRACIN/POLYSPORIN AND TOPICAL HYDROCORTISONE 1% ON SURROUNDING AREA AND ORAL CEPHALEXIN. THE RASH RESOLVED.
Patient problems: Rash
MAUDE report 7554853 ↗InjuryMay 30, 2018Insufficient Device Problem Information
THE CUSTOMER STATED THAT ONE OF THEIR PATIENTS DEVELOPED A RASH TO THE LOWER LID AND CHEEK FOLLOWING AN OPHTHALMIC SURGERY. THE COMPONENT SOURCE WAS UNKNOWN, BUT THE CUSTOMER FELT IT COULD POSSIBLY BE FROM THE TRANSPARENT DRESSING TD-24CNS2 FROM THE BASIC CATARACT PACK/ SEY54CPCAN. THE PATIENT WAS TREATED WITH TOBRADEX OINTMENT AND RASH RESOLVED.
Patient problems: Rash
MAUDE report 7554762 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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