Disposable Pneumatic Vitrectome.(23 gauge / 0.6 mm)(working with 30 P.S.I., max. 1267.NMD06Recalls & 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
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08717872001418), received between Feb 16, 2018 and Apr 4, 2018 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Device Operational Issue” (4 reports).
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
- Device Operational Issue4
Patient problems
- No Consequences Or Impact To Patient4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 4, 2018Device Operational Issue; Device Operational Issue
A REPORT HAS BEEN RECEIVED THAT HAS REPORTED THE FOLLOWING INCIDENT: "THE SHANDONG DISTRIBUTOR FILED A COMPLAINT THAT THE CUTTERS RELEASED BUBBLES DURING THE SURGERY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7397153 ↗MalfunctionMar 29, 2018Device Operational Issue; Device Operational Issue
A REPORT HAS BEEN RECEIVED THAT HAS REPORTED THE FOLLOWING INCIDENT: "THE (B)(4) DISTRIBUTOR FILED A COMPLAINT THAT THE CUTTERS RELEASED BUBBLES DURING THE SURGERY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7382197 ↗MalfunctionFeb 16, 2018Device Operational Issue; Device Operational Issue
A REPORT HAS BEEN RECEIVED OF AN INCIDENT THAT OCCURRED IN (B)(6). AIR BUBBLE CAME OUT FROM THE CUTTER PORT. SINCE WE NEED TO REPORT THE REASON OF THIS PROBLEM TO THE DOCTOR, YOUR PROMPT ACTION WOULD BE GREATLY APPRECIATED. THERE IS NO FURTHER INFORMATION. ALL HAS BEEN DISCLOSED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7278468 ↗MalfunctionFeb 16, 2018Device Operational Issue; Device Operational Issue
A REPORT HAS BEEN RECEIVED OF AN EVENT THAT OCCURRED IN (B)(6). THE BUBBLE CAME OUT FROM THE CUTTER PORT. WOULD IT BE POSSIBLE TO INVESTIGATE CAREFULLY AND LET US KNOW THE CAUSE? THERE IS NO FURTHER INFORMATION AND ALL HAS BEEN DISCLOSED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7278276 ↗
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- Alcon 8065752201Alcon Laboratories, Inc. · Unit, phacofragmentation1 recall386 reports
- Alcon 8065752200Alcon Laboratories, Inc. · Unit, phacofragmentation1 recall366 reports
- Constellation, Ultravit, 25+, TotalPlus, EdgePlus 8065751767Alcon Laboratories, Inc. · Unit, phacofragmentation2 recalls302 reports
- Constellation, ULTRAVIT, Engauge, 25+ 8065752415Alcon Laboratories, Inc. · Unit, phacofragmentation369 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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