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OPMI® Drapes sterile 306026-0000-000Recalls & 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 04049539101198), received between Dec 10, 2018 and Dec 10, 2018 — classified as 1 malfunction.

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

  • Appropriate Device Problem Term/Code Not Available1

Patient problems

  • No Patient Involvement1

Recent adverse event reports

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

  • MalfunctionDec 10, 2018Appropriate Device Problem Term/Code Not Available

    HAIR WAS FOUND IN THE PACKAGE BEFORE IT WAS OPENED IN THE OPERATING ROOM. IT WAS FOUND IN THE OPMI DRAPES STERILE PACKAGE MANUFACTURED BY CARL ZEISS (B)(4). THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Patient Involvement

    MAUDE report 8145988 ↗

Other Drape, Surgical devices

All Drape, Surgical devices →

Sources and updates

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