EVA, combined machine 8000.COM01 (UDI 08717872019642)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08717872019642), received between Sep 12, 2017 and Feb 27, 2018 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 27, 2018Increase in Pressure; Pressure Problem; Increase in Pressure; Pressure Problem

  A CLINIC IN SPAIN HAS REPORTED CORNEAL EDEMA AFTER SURGERY. THERE IS NO FURTHER DETAILED INFORMATION AT THIS TIME. WE HAVE REACHED OUT FOR ADDITIONAL INFORMATION AND A FOLLOW UP WILL BE SUBMITTED SHOULD ANY NEW INFORMATION BE RECEIVED.

  Patient problems: Corneal Edema

  MAUDE report 7300272 ↗
• MalfunctionFeb 27, 2018Increase in Pressure; Pressure Problem; Increase in Pressure; Pressure Problem

  IT WAS ALSO REPORTED BY THE SURGEON THAT DURING EYE SURGERY, THE SURGEON EXPERIENCED HIGH IRRIGATION PRESSURE INTO THE EYE. CORNEA EDEMA APPEARED. WE ARE IN THE PROCESS OF GATHERING ADDITIONAL INFORMATION.

  Patient problems: Corneal Edema

  MAUDE report 7300107 ↗
• MalfunctionFeb 20, 2018Device Operational Issue; Device Operational Issue

  A FACILITY IN (B)(6) HAS REPORTED THE FOLLOWING: "CAN YOU PLEASE MAKE A COMPLAINT PHACO SUDDENLY STOPS WORKING, ERROR MESSAGE NOT KNOWN." SAMPLE WAS RETURNED. ALL INFORMATION HAS BEEN DISCLOSED. NO REPORT OF PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7283267 ↗
• MalfunctionSep 14, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DURING SURGERY, THE SCREEN FROZE AND THEREFORE THE EVA WAS TURNED OFF AND ON. IN THE MEANTIME, THE EYE TURNED TO HYPOTONIC.

  Patient problems: Eye Injury

  MAUDE report 6866886 ↗
• InjurySep 12, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  A REPORT HAS BEEN RECEIVED FROM (B)(6) FROM A USER FACILITY WHO REPORTED DURING PHACO SURGERY THE SURGEON EXPERIENCED A CAPSULAR RUPTURE. IT WAS REPORTED THAT THE SURGEON WAS NOT HAPPY WITH THE PHACO PERFORMANCE. IT WAS ALSO REPORTED A SULCUS IOL WAS IMPLANTED IN THE MEAN TIME. THE SURGERY HAS BEEN RESCHEDULED. A SUPPLEMENTAL REPORT WILL BE FILED AS SOON AS ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: Optical Tissue, Breakdown Of

  MAUDE report 6858191 ↗