CONVERTORS D1061Recalls & reported problems
Cardinal Health 200, LLC · Ophthalmic Incise Drape · Class 2
Data updated Oct 13, 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 10885380061066), received between Aug 9, 2017 and Aug 9, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Device Operates Differently Than Expected1
Patient problems
- No Information1
- Peeling1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 9, 2017Device Operates Differently Than Expected
RECEIVED COMPLAINT THAT STATED THE ADHESIVE ON THE DRAPE WAS TOO STRONG, AND PEELED THE SKIN AND RIPPED EYE LASHES OFF WHEN REMOVING. THE COMPLAINT WAS ORIGINALLY RECEIVED IN MAY, AND MULTIPLE ATTEMPTS WERE MADE TO OBTAIN INFORMATION FROM THE CUSTOMER, HOWEVER THE END USER DID NOT RESPOND. ON (B)(6) THE CUSTOMER REPORTED THAT THE END USER HAD CONTACTED THEM WITH INFORMATION THAT ANTIBIOTIC OINTMENT AND STEROIDS WERE USED FOR PEELED SKIN; AND THAT SKIN AND LASHES ARE OK NOW. THE CUSTOMER REPORTED THAT THEY DOUBTED THERE WOULD BE ANY FURTHER SPECIFIC INFORMATION FROM THE END USER.
Patient problems: No Information; Peeling
MAUDE report 6778502 ↗
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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