EVA, combined machine including Laser (SMA connector)Recalls & reported problems across all models
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · 2 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 23
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls
- 0
We found 2 models of EVA, combined machine including Laser (SMA connector) by D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. in the FDA's device registry (GUDID). Together they are named in 23 adverse event reports in the FDA's MAUDE database, received between Feb 20, 2018 and Jul 9, 2018 — classified as 6 injuries, 17 malfunctions.
The most frequently reported specific device problem is “Device Operational Issue” (17 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Most reported EVA, combined machine including Laser (SMA connector) problems
Device problems
- Device Operational Issue17
- Adverse Event Without Identified Device or Use Problem2
- Device Inoperable2
- Break1
- Decrease in Suction1
- Device Displays Incorrect Message1
- Increase in Pressure1
- Self-Activation or Keying1
Patient problems
- No Consequences Or Impact To Patient13
- Eye Injury5
- Loss of Vision3
- No Information1
- No Known Impact Or Consequence To Patient1
EVA, combined machine including Laser (SMA connector) models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- EVA, combined machine including Laser (SMA connector) 8000.COM03Laser, Ophthalmic20 reports
- EVA, combined machine including Laser (SMA connector) 8000.COM03Unit, Phacofragmentation3 reports
Recent EVA, combined machine including Laser (SMA connector) adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJul 9, 2018Break
ERROR CODE FOP5001 DEVICE HARDWARE. FOOT PEDAL FAILED DURING SURGERY UNABLE TO PROCEED WITH CASE. MODULE WILL BE REPLACED.
Patient problems: No Information
MAUDE report 7670532 ↗MalfunctionJul 9, 2018Increase in Pressure; Self-Activation or Keying
THE IOP (IRRIGATION PRESSURE) ON THE MACHINE REACHED TO MAXIMUM 150MMHG BY ITSELF DURING THE PROCEDURE. THIS CAN CAUSE TOO CRITICAL MEDICAL COMPLICATIONS. NO ERROR MESSAGES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7669602 ↗MalfunctionJul 9, 2018Decrease in Suction
PUM258 RECURRENT WARNING MESSAGE WITH LOW VACUUM, UNABLE TO PROCEED DURING SURGERY. PUMP MODULE WILL BE REPLACED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7669501 ↗MalfunctionJul 5, 2018Device Operational Issue; Device Operational Issue
MACHINE SUDDENLY STOPPED RESPONDING, THE SCREEN WAS FROZEN, IT WAS ASPIRATING AND IRRIGATING ALTHOUGH NO ONE WAS PRESSING THE FOOTSWITCH, THERE WAS NO ERROR MESSAGE AND IT WAS IMPOSSIBLE TO TURN OFF THE MACHINE. AFTER REBOOTING THE EVA DIRECTLY FROM THE MAIN SWITCH ON THE BACK, THE SYSTEM ENTERED THE DEMO MODE EVERY TIME. WE TRIED TO REBOOT IT PLENTY OF TIMES BUT IT KEPT ENTERING THE DEMO MODE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7664852 ↗MalfunctionJun 29, 2018Device Operational Issue; Device Operational Issue
ERROR CODE VIT2 - NO PRESSURE AT VIT MODULE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7652711 ↗MalfunctionJun 26, 2018Device Operational Issue; Device Operational Issue
EVA FAILED DURING CASE. VFI NOT ABLE TO INJECT OIL. CAUTERY STOPPED WORKING IN MIDDLE OF CASE. ERROR CODE CAR199. VFIE MODULE WILL BE REPLACED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7638021 ↗InjuryJun 22, 2018Device Operational Issue; Device Operational Issue
A SURGEON REPORTED AN INCIDENT OF CENTRAL RETINAL ARTERY OCCLUSION. NO FURTHER INFORMATION.
Patient problems: Eye Injury
MAUDE report 7630654 ↗InjuryJun 22, 2018Device Operational Issue; Device Operational Issue
A SURGEON REPORTED AN INCIDENT OF CENTRAL RETINAL ARTERY OCCLUSION. NO FURTHER INFORMATION.
Patient problems: Eye Injury
MAUDE report 7630614 ↗InjuryJun 22, 2018Device Operational Issue; Device Operational Issue
A SURGEON REPORTED AN INCIDENT OF CENTRAL RETINAL ARTERY OCCLUSION. NO FURTHER INFORMATION.
Patient problems: Eye Injury
MAUDE report 7630612 ↗InjuryJun 22, 2018Device Operational Issue; Device Operational Issue
A SURGEON REPORTED AN INCIDENT OF CENTRAL RETINAL ARTERY OCCLUSION. NO FURTHER INFORMATION.
Patient problems: Eye Injury
MAUDE report 7630601 ↗MalfunctionJun 20, 2018Device Operational Issue; Device Operational Issue
POST VITRECTOMY OPTIC NEUROPATHY REPORTED BY THE SURGEON. INCIDENT IS POSSIBLY RELATED TO PATIENT EYE LEVEL AND BOTTLE HEIGHT. THE SURGEON ROUTINELY PLACES PATIENTS IN TRENDELENBERG, WHICH COULD BE INDUCING GRAVITY INFUSION IN ADDITION TO PRESSURIZED IOP. PATIENT EYE LEVEL HAS BEEN ADJUSTED IN THE MACHINE.
Patient problems: Eye Injury
MAUDE report 7622344 ↗MalfunctionJun 20, 2018Device Operational Issue; Device Operational Issue
IT WAS HAPPENED THAT VIT2 APPEARED ON EVA AND THE SCREEN WENT RED DURING VIT SURGERY, AND TO CLEAR THE ERROR THEY TURNED OFF, REBOOTED AND DID RE-PRIMING WITH INFUSION TUBING CONNECTED WITH PATIENT EYE, BECAUSE HIS NURSE INSISTED THAT OUR YOUNG SALES REPS SAY IT IS POSSIBLE BY PHONE CONVERSATION. THE PRIMING COMPLETED SUCCESSFULLY. AFTER SURGERY, HIS PATIENT LOST THE SIGHT OF HIS EYE AND REQUESTED HIM TO SUBMIT HIS CLINICAL RECORD. THE DR. REALLY WOULD LIKE TO KNOW POSSIBLE IMPACTS THAT MIGHT BE CAUSED BY CONTINUING TO APPLY 100MMHG OF IRRIGATION PRESSURE TO THE EYE FOR AT LEAST 1 MINUTE DURING PRIMING. HE WOULD LIKE TO KNOW THE REASON HIS PATIENT LOST THE SIGHT OF HIS EYE AND IF IT WAS BECAUSE OF EVA OR NOT. THE DR. INSISTS THAT THE PRIMING SHOULD NOT COMPLETED WITH INFUSION TUBING CONNECTED WITH PATIENT EYE. THIS PATIENT HAD AN ARTERY STENOSIS AND FURTHER INVESTIGATION DETERMINED THAT THE ARTERY STENOSIS WAS PRESENT PRIOR TO THE START OF THE SURGERY. IN COLLABORATION WITH THE PHYSICIAN WE CONCLUDE THAT THIS IS THE MAIN REASON FOR THE LOST OF SIGHT BY THE PATIENT.
Patient problems: Loss of Vision
MAUDE report 7622147 ↗MalfunctionJun 11, 2018Device Operational Issue; Device Operational Issue
FOOT PEDAL STOPPED WORKING IN MIDDLE OF CASE WHILE CABLED TO EVA. CUSTOMER NOT ABLE TO CONNECT FOOT PEDAL WIRELESSLY. RESTARTED MACHINE, STILL RECEIVED ERROR CODE FOP3102 BUT WAS ABLE TO RESOLVE ERROR CODE AND CONTINUE CASE. NEW FOOT PEDAL WILL BE SENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7589137 ↗MalfunctionMay 30, 2018Device Inoperable; Device Operational Issue; Device Operational Issue
FAILURE FOOTPEDAL, FOOTPEDAL WENT DEAD AND WILL EVEN NOT WORK WHEN IT IS PLUGGED IN. NEW FOOTPEDAL WILL BE SENT. MODULE (B)(4) WILL BE RETURNED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7552853 ↗MalfunctionMay 21, 2018Device Operational Issue; Device Operational Issue
THE VITRECTOME MADE A LOT OF BUBBLES. AIR INTAKE PROBLEM. NO REPORT OF INJURY. ALL INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7530336 ↗
Other D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. products
All D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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