EVA TDC Vitrectomy Pack VGPC Input 25G 8310.25G02Recalls & 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08717872021041), received between Aug 18, 2017 and Aug 18, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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
- Insufficient Device Problem Information1
- Obstruction of Flow1
Patient problems
- Intraocular Pressure, Delayed, Uncontrolled1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 18, 2017Obstruction of Flow; Insufficient Device Problem Information; Obstruction of Flow; Insufficient Device Problem Information
DURING THE COMBINED PHACOEMULSIFICATION AND PARS PLANA VITRECTOMY SURGERY, THE SURGEON EXPERIENCED LOW IRRIGATION PRESSURE AND THE PATIENT'S EYE TURNED TO VERY SOFT. NO PATIENT INJURY, HOWEVER SURGERY WAS PROLONGED FOR ABOUT 30 MINUTES. THE FACILITY WAS COMMUNICATED WITH TO INVESTIGATE THE CIRCUMSTANCES OF THE EVENT AS WELL AS WITH THE SURGEON AND NURSES. THE LOG FILES RECEIVED HAVE BEEN REVIEWED. PLEASE NOTE THIS INCIDENT OCCURRED IN (B)(6).
Patient problems: Intraocular Pressure, Delayed, Uncontrolled
MAUDE report 6803726 ↗
Other Unit, Phacofragmentation devices
- Centurion 8065751763Alcon Laboratories, Inc. · Unit, phacofragmentation728 reports
- Centurion 8065753057Alcon Laboratories, Inc. · Unit, phacofragmentation639 reports
- CENTURION® 8065752914Alcon Laboratories, Inc. · Unit, phacofragmentation571 reports
- Constellation, Ultravit, 25+, TotalPlus, EdgePlus 8065751617Alcon Laboratories, Inc. · Unit, phacofragmentation2 recalls398 reports
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page