OPMI® Drapes sterile 306070-0000-000Recalls & reported problems
Carl Zeiss Meditec AG · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04049539101204), received between Aug 6, 2021 and Aug 6, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Contamination” (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
- Contamination1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 6, 2021Contamination
DURING CASE SET UP A BUG WAS DISCOVERED IN THE MICROSCOPE DRAPE. THE WHOLE FIELD WAS CONTAMINATED AND BROKEN DOWN. CASE WAS NOT STARTED. DRAPE AND PACKAGING SAVED TO GIVE TO QUALITY. PICTURES ATTACHED. DRAPE AND PACKAGING SAVED
Patient problems: Insufficient Information
MAUDE report 12286924 ↗
Other Drape, Surgical devices
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- Medline DYNJP2410Medline Industries, Inc. · Drape, surgical2 recalls2 reports
- Medline DYNJP2414RMedline Industries, Inc. · Drape, surgical2 recalls2 reports
- Medline DYNJP2411Medline Industries, Inc. · Drape, surgical2 recalls2 reports
- Medline DYNJP2416Medline Industries, Inc. · Drape, surgical2 recalls1 report
- Medline DYNJP3008UGMedline Industries, Inc. · Drape, surgical2 recalls1 report
- Medline DYNJP2412TMedline Industries, Inc. · Drape, surgical2 recalls0 reports
- Medline DYNJP8412UGMedline Industries, Inc. · Drape, surgical2 recalls0 reports
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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