EVA, combined machine including Laser (DORC connector) 8000.COM02Recalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 08717872019659), received between Oct 12, 2017 and Jul 5, 2018 — classified as 14 injuries, 30 malfunctions.

The most frequently reported specific device problem is “Device Operational Issue” (33 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 44 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 5, 2018Device Operational Issue; Device Operational Issue

  LOW VOLTAGE ON FOOT PEDAL, CANNOT CLEAR MESSAGE AND UNABLE TO PROCEED WITH PROCEDURE. PEDAL DOES NOT WORK WIRELESSLY NOR HARDWIRED. NEW PEDAL AND CABLES REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7664982 ↗
• MalfunctionJul 5, 2018Device Operational Issue; Device Operational Issue

  DURING VITRECTOMY PRESSURE ROSE TO 111 MMHG AND WOULD NOT REDUCE, HIGHLY DANGEROUS TO OPTIC NERVE. UNFORTUNATELY WE CAN'T SEE WHY THE SYSTEM GOT STUCK. THEY DID A LOT OF PROGRAMMING THIS DAY MAYBE THIS CAUSED THE PROBLEM, WE DON'T KNOW. RECOMMEND TO JOIN THE SURGEONS A COMPLETE DAY AND MONITOR THE UNIT, BETTER SHOULD BE TO CHECK UP THE UNIT BEFORE USE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7664894 ↗
• InjuryJun 29, 2018Device Operational Issue; Device Operational Issue

  DUE TO A LASER DEFECT THEY HAD TO REPRIME THE MACHINE AT A STAGE OF THE AIR INJECTION SURGICAL STEP. THIS HAS CAUSED AN INCREASE IN THE EYE PRESSURE AS THE TUBING WAS STILL CONNECTED. ADDITIONALLY INFORMATION REPORTED THAT THE INCREASE IN PRESSURE CAUSED RETINAL ISCHEMIA AND LOSS OF EYE.

  Patient problems: Eye Injury; Intraocular Pressure Increased

  MAUDE report 7651875 ↗
• MalfunctionJun 29, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  THERE WAS SOMETHING ON THE CUTTER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7651440 ↗
• MalfunctionJun 28, 2018Device Operational Issue; Device Operational Issue

  IRRIGATION SPONTANEOUSLY SWITCHES OFF DURING OIL EXTRACTION, NO ALERT FROM THE EVA THAT THE IRRIGATION WAS SWITCHED OFF. THIS CAUSED A SOFT EYE.

  Patient problems: Intraocular Pressure, Delayed, Uncontrolled

  MAUDE report 7648215 ↗
• MalfunctionJun 28, 2018Device Operational Issue; Device Operational Issue

  IRRIGATION SPONTANEOUSLY SWITCHED OFF. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7648088 ↗
• InjuryJun 28, 2018Device Operational Issue; Device Operational Issue

  PLEASE NOTE: THIS INCIDENT IS RELATED TO MEDWATCH (B)(4) SUBMITTED TO FDA BY THE USER FACILITY. THIS WAS RECEIVED ON 06/19/2018. WE HAVE REACHED OUT TO THE FACILITY FOR ADDITIONAL INFORMATION.

  Patient problems: Eye Injury

  MAUDE report 7646534 ↗
• MalfunctionJun 26, 2018Device Operational Issue; Device Operational Issue

  COMPLAINT: IRRIGATION SPONTANEOUSLY SWITCHES OFF, NO VERBAL ANNOUNCEMENT FROM EVA. IRRIGATION ICON TURNS STATIS (NO FADING EFFECT), TEXT: "IRRIGATION OFF" IS SHOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7638733 ↗
• MalfunctionJun 26, 2018Device Operational Issue; Device Operational Issue

  AFTER SALES ASKED US TO ENTER THE FOLLOWING COMPLAINT: THE SURGEON EXPERIENCED A SOFT EYE DURING A VITRECTOMY PROCEDURE (PEELING). THE EYE BECAME SOFT AND HE WAS LOOKING AT THE SCREEN AND NOTICED THAT THE IRRIGATION WAS TURNED OFF BY ITSELF. HE WAS NOT INFORMED BY THE SYSTEM ( VOICE) THAT IT WAS TURNED OFF.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7638671 ↗
• MalfunctionJun 25, 2018Device Displays Incorrect Message; Device Operates Differently Than Expected

  DURING SURGERY PHACO WENT LOWER AND LOWER; CHANGED HP NO US POWER. ERROR CODE PHA 103/104.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7635389 ↗
• MalfunctionJun 22, 2018Device Operational Issue; Device Operational Issue

  PUMP IN ERROR "PUMP152" AND SYSTEM NOT WORKING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7631365 ↗
• InjuryJun 19, 2018Device Operational Issue; Device Operational Issue

  THEY STOP THE SURGERY AND TRANSFER THE PATIENT. PCB HOLDER CHARGED 2 TIMES, MAIN PEDAL CHANGED 5 TIMES . FOP ERROR BLOCKAGE DURING SURGERY. IN A REVIEW THE INFORMATION REASONABLY SUGGESTS THAT THIS PATIENT WAS UNDERGOING SURGERY WHEN THE INCIDENT OCCURRED AND THE PATIENT WAS TRANSFERRED TO ANOTHER UNIT FOR COMPLETION OF THE SURGERY. ALL INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Code Available

  MAUDE report 7616007 ↗
• MalfunctionJun 13, 2018Material Separation; Material Separation

  VIT 3 SEVERAL PRIMING FAILS AND A BREAKDOWN DURING SURGERY. MODULE HAS BEEN REPLACED. MODULE (B)(4) HAS BEEN RETURNED. NO REPORT OF PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7597998 ↗
• InjuryJun 11, 2018Intermittent Infusion; Improper Flow or Infusion; Intermittent Infusion; Improper Flow or Infusion

  DURING THE SURGERY, THE EVA GAVE IRREGULAR IRRIGATION PRESSURE, WITH NO BACKFLUSH. HYPOTONIC EYE OCCURRED. IT WAS REPORTED NO PATIENT HARM HAD OCCURRED.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 7586343 ↗
• InjuryJun 8, 2018Intermittent Infusion; Improper Flow or Infusion; Intermittent Infusion; Improper Flow or Infusion

  DURING THE SURGERY, THE EYE PRESSURE WAS TOO HIGH. WITH ONLY AT 4 MMHG, THE VESSELS BECAME RED. NO BACKFLUSH. IRREGULAR IRRIGATION PRESSURE.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 7582754 ↗
• MalfunctionJun 5, 2018Device Operational Issue; Device Operational Issue

  A REPORT FROM (B)(6) HAS BEEN RECEIVED AND REPORT A SOFT EYE ISSUE WHEN SWITCHING FROM PHACO TO VITRECTOMY IN 25 COMBINED PROG. AT OUR CUSTOMER THERE ARE INFUSION PROBLEMS ON EVA. THE SURGEON STILL HEARS THE SOUND OF THE DROPS/DROP NOISE, BUT THERE IS NO INFUSION, WHY THE EYES COLLAPSE. THERE IS NO INFORMATION ON INTERVENTION PROVIDED.

  Patient problems: Intraocular Pressure, Delayed, Uncontrolled

  MAUDE report 7568989 ↗
• MalfunctionJun 5, 2018Device Operational Issue; Device Operational Issue

  AT OUR CUSTOMER THERE ARE INFUSION PROBLEMS ON EVA. THE SURGEON STILL HEARS THE SOUND OF THE DROPS/DROP NOISE, BUT THERE IS NO INFUSION, WHY THE EYES COLLAPSE.

  Patient problems: Intraocular Pressure, Delayed, Uncontrolled; No Consequences Or Impact To Patient

  MAUDE report 7568814 ↗
• MalfunctionMay 24, 2018Device Operates Differently Than Expected

  MAINBOARD IS GOING TO BOOTLOADER MODUS BY ITSELF DURING SHAVING (NEAR RETINA ) PROCEDURE. ALL WENT RED AND UNIT MUST BE SWITCHED OFF FROM BACKSIDE DURING SURGERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7541299 ↗
• MalfunctionMay 23, 2018Device Operational Issue; Device Operational Issue

  DURING SURGERY, THE SURGEON WAS SWITCHING BETWEEN ANTERIOR (I/A) AND POSTERIOR (VITRECTOME) MODES. WHEN HE SWITCHED OFF THE INFUSION ON HIS FOOT PEDAL DURING I/A MODE, THE MACHINE ASPIRATED AT THE POSTERIOR (CORE VITRECTOMY) MODE, BUT THERE WAS NO INFUSION (THE INFUSION WAS OFF) IN THE MEANWHILE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7536664 ↗
• MalfunctionMay 22, 2018Device Operational Issue; Device Operational Issue

  PUMP ERROR 152 - HIGH TEMPERATURE = MOTOR FAILURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7535386 ↗
• MalfunctionMay 22, 2018Material Separation; Material Separation

  THEIR PHACO FRAGMENTATION TIP BROKE DURING SURGERY. MOST LIKELY LOT NUMBERS (B)(6) 2015 NO SAMPLE AND NO REPORT OF INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7535346 ↗
• MalfunctionMay 22, 2018Device Operational Issue; Device Operational Issue

  HARDWARE ERROR DETECTED IN THE MAIN PEDAL, ERROR MESSAGE FOP 5007. MAIN PEDAL MUST BE REPLACED. PLEASE NOTE IT WILL BE RETURNED TO ZUIDLAND TOGETHER WITH THE PUMP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7535289 ↗
• MalfunctionMay 18, 2018Device Operational Issue; Device Operational Issue

  THE HEAD SURGEON INDICATES, THAT AT SEVERAL OCCASIONS DURING SURGERY, HE SAW THE BLOOD VESSELS CONTRACTING AND FELT THAT THE PRESSURE IS MUCH HIGHER THAN THE 20MMHG DISPLAYED IN THE SETTINGS. HE WAS QUESTIONING IF THE BOTTLE PRESSURE DISPLAYED IS CORRECT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7526214 ↗
• MalfunctionMay 15, 2018Device Operational Issue; Device Operational Issue

  PUMP ERROR CAR1600 ( SERVO ERROR PUMP ACTUATOR ) OCCURS DURING PHACO. IT FOLLOWS AFTER EACH OTHER. SAMPLE AVAILABLE. ALL INFORMATION AVAILABLE HAS BEEN DISCLOSED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7516818 ↗
• MalfunctionMay 15, 2018Device Operational Issue; Device Operational Issue

  DORC BECAME AWARE OF A POTENTIAL PERFORMANCE ISSUE CONCERNING THE VFI ADAPTER OF THE VFI PACK FOR SILICONE OIL SYRINGES DURING USE IN COMBINATION WITH GLASS PREFILLED SILICONE OIL SYRINGE. INVESTIGATION SHOWED THAT THE DORC VFI PACK FOR SILICONE OIL SYRINGE (1363.DD) CAN LEAD TO BREAKING OF THE GLASS SYRINGE WHEN MOUNTING THE SYRINGE IN THE ADAPTER. NO INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7515521 ↗