CARDINAL HEALTH SEY24ACCTHRecalls & reported problems
Cardinal Health 200, LLC · STERILE CATARACT 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 10885425988136), received between Jun 8, 2021 and Jun 8, 2021 — classified as 2 injuries.
The most frequently reported specific device problem is “Contamination” (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
- Contamination2
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Eye Infections2
- Unspecified Infection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 8, 2021Adverse Event Without Identified Device or Use Problem; Contamination; Adverse Event Without Identified Device or Use Problem
CUSTOMER REPORTED THAT THEY HAVE HAD A FEW EYE INFECTIONS DURING THE TIME THEY HAVE USED THE CATARACT PACK SEY24ACCTH FROM LOT NUMBER 577589. THE SCRUBS AND RNS MET AND BRAINSTORMED AND APPARENTLY THE SCRUBS HAVE SEEN ¿PARTICLES¿ SUCH AS PLASTIC IN THE PACKS BEFORE. PATIENT DEVELOPED AN EYE INFECTION 7 DAYS POST-OP REQUIRING ANTIBIOTIC TREATMENT FROM A RETINAL SPECIALIST. CUSTOMER STATED SINCE IT HAS BEEN YEARS SINCE THEY HAVE HAD ANY COMPLICATION FROM A SURGICAL PROCEDURE, THEY ARE LOOKING AT ¿EVERYTHING¿ BUT THEY ARE UNABLE TO PINPOINT A COMPONENT THAT WAS CONTAMINATED.
Patient problems: Eye Infections
MAUDE report 11960180 ↗InjuryJun 8, 2021Contamination
PATIENT REPORTED THAT THEY HAVE HAD A FEW EYE INFECTIONS DURING THE TIME THEY HAVE USED THE CATARACT PACK SEY24ACCTH FROM LOT NUMBER 57789. THE SCRUBS AND RNS MET AND BRAINSTORMED AND APPARENTLY THE SCRUBS HAVE SEEN ¿PARTICLES¿ SUCH AS PLASTIC IN THE PACKS BEFORE. PATIENT DEVELOPED AN EYE INFECTION 6 DAYS POST-OP REQUIRING ANTIBIOTIC TREATMENT FROM A RETINAL SPECIALIST. THEY STATED SINCE IT HAS BEEN YEARS SINCE THEY HAVE HAD ANY COMPLICATION FROM A SURGICAL PROCEDURE, THEY ARE LOOKING AT ¿EVERYTHING¿ BUT THEY ARE UNABLE TO PINPOINT A COMPONENT THAT WAS CONTAMINATED.
Patient problems: Eye Infections; Unspecified Infection
MAUDE report 11959389 ↗
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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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