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Disposable Eckardt Twinlight Chandelier. (27 gauge / 0.4mm) 3269.MBD27Recalls & reported problems

D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · 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 08717872021942), received between May 2, 2018 and May 2, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (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

  • Material Separation1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

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

  • MalfunctionMay 2, 2018Material Separation; Material Separation

    A REPORT HAS BEEN RECEIVED OF AN EVENT THAT OCCURRED IN (B)(6): THERE HAVE BEEN TWO PARTICLES WHICH ARE PROBABLY FROM THE SILICON MEDICAL GRADE. IT`S DIFFICULT TO RECOGNIZE AT THE PHOTOS BUT WE COULD DEFINITELY SEE THEM. SHE TRIED TO SAVE THEM BUT THEY HAVE BEEN TOO THIN SO WE LOST THEM.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7480345 ↗

Other Endoilluminator devices

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Sources and updates

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