EVA, combined machine 8000.COM01 (UDI 08717872029672)Recalls & reported problems
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Class 2
Data updated Oct 16, 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 08717872029672), received between Feb 27, 2018 and Feb 27, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Increase in Pressure” (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 16, 2026.
Most reported problems
Device problems
- Increase in Pressure1
- Pressure Problem1
Patient problems
- Corneal Edema1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 27, 2018Increase in Pressure; Pressure Problem; Increase in Pressure; Pressure Problem
A REPORT HAS BEEN RECEIVED FROM (B)(6). THE SURGEON REPORTED THAT DURING EYE SURGERY, THE SURGEON EXPERIENCED HIGH IRRIGATION PRESSURE INTO THE EYES. CORNEA EDEMA APPEARED. NO FURTHER INFORMATION AT THIS TIME. A REQUEST HAS BEEN MADE FOR ADDITIONAL INFORMATION.
Patient problems: Corneal Edema
MAUDE report 7300517 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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