EVA, combined machine including Laser (SMA connector) 8000.COM03 (UDI 08717872019666)Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 08717872019666), received between Apr 18, 2018 and Jul 9, 2018 — classified as 4 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Device Operational Issue” (16 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

Recent adverse event reports

The 20 most recent of 20 reports, 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 ↗
• MalfunctionMay 17, 2018Device Operational Issue; Device Operational Issue

  ERROR MESSAGE, PUM63 SUPPLY PRESSURE SWITCH ON, SUPPLY PRESSURE TOO LOW, WATER DETECTED, ASPIRATION MODULE WILL BE DEACTIVATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7522523 ↗
• MalfunctionMay 15, 2018Device Operational Issue; Device Operational Issue

  WE RECEIVED A COMPLAINT IT SEEMS TO HAVE TRACE OF " LIMESTONE" ON IT. SAMPLE AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7516740 ↗
• MalfunctionMay 15, 2018Device Operational Issue; Device Operational Issue

  ERROR: PUM152. TEMPERATURE ERROR, MOTOR BROKEN. ALL INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7515727 ↗
• MalfunctionMay 2, 2018Device Inoperable; Device Displays Incorrect Message

  VIT7 ERROR OCCURRED (FAULTY CUTTER DETECTED) AND THEY HAD TO ABORT SURGERY. THE PATIENT WAS BEING ANESTHETIZED, AND DUE TO THE ERROR, THE SURGERY CANNOT BE STARTED AND THE SURGEON HAD TO WAKE UP THE PATIENT. THE SURGEON RESCHEDULED ANOTHER SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7481037 ↗
• MalfunctionApr 18, 2018Device Operational Issue; Device Operational Issue

  THIS INCIDENT OCCURRED IN SLOVENIA. VIT3 AND VIT 999 ERROR MESSAGES THAT WERE FOLLOWING AND REFLECTING VITRECTOMY MALFUNCTION. AFTER VERIFYING THE PRESSURE GOING INTO THE MODULE TO BE ON REQUIRED LEVEL OF 6 BARS IT WAS DECIDED TO REPLACE VITRECTOMY MODULE BY THE NEW ONE AS THE INNER PRESSURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7441687 ↗