EVA, combined machine including Laser (SMA connector) 8000.COM03 (UDI 08717872002910)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08717872002910), received between Feb 20, 2018 and Mar 30, 2018 — classified as 2 injuries, 1 malfunction.

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

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 30, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY STATES A CONCERN WITH OUR MACHINE AND ASKS IF WE HAVE ANY KNOWN CASES OF PHOTOTOXICITY. THE FACILITY REPORTS A CASE WITH WIDESPREAD RPE WIPEOUT. THE FACILITY HAD BEEN USING THE LIGHT AT 100%, AND REQUEST THAT MAYBE SOMEONE FROM OUR COMPANY TAKES A LOOK AT THE INCIDENT IN QUESTION. THIS SUBJECT NOTICED A GRADUAL DECREASE IN THE VISION OF THE LEFT EYE AND WAS NOTED TO HAVE A PRE-EXISTING MODERATE CATARACT AND WORSENING VITREOMACULAR TRACTION WHICH DROPPED THE VISION TO THE 20/50 TO 20/60 LEVEL. A DETERMINATION WAS THAT A COMBINED SURGERY COULD BE PERFORMED TO IMPROVE THE VISION. THE SUBJECT UNDERWENT SURGERY ON (B)(6) 2018. WASH TRIESENCE WAS INJECTED INTO THE MIDVITREOUS, AND VITRECTOMY WAS PERFORMED. WASH TRIESENCE WAS AGAIN INJECTED TO ENSURE ALL EPIRETINAL MEMBRANE WAS REMOVED. TRIESENCE WAS INJECTED OVER THE POSTERIOR POLE AND EXCESS REMOVED WITH THE VITREOUS CUTTER. THERE DID APPEAR TO BE A PERSISTENT EPIRETINAL MEMBRANE, BUT AT THIS POINT, NO EDGE WAS IDENTIFIED. IT WAS IDENTIFIED THIS COULD BE THE INTERNAL LIMITING MEMBRANE, SO ICG WAS MIXED ACCORDING TO A KNOWN RECIPE AND INJECTED OVER THE POSTERIOR POLE ALLOWING IT TO SETTLE AND STAIN THE INTERNAL LIMITING MEMBRA

  Patient problems: Loss of Vision

  MAUDE report 7386201 ↗
• InjuryMar 30, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPORTS A CONCERN WITH OUR MACHINE AND WANTS TO KNOW IF WE ARE AWARE OF ANY CASES OF PHOTOTOXICITY. THE FACILITY REPORTS A CASE WITH WIDESPREAD RPE WIPEOUT. THEY HAD BEEN USING THE LIGHT AT 100%, AND REQUEST THAT MAYBE SOMEONE FROM OUR COMPANY TAKES A LOOK AT THE INCIDENT. IN SPEAKING WITH THE FACILITY, WE LEARN THAT A SUBJECT UNDERWENT EYE SURGERY FOR A COMBINED RHEGMATOGENOUS RETINAL DETACHMENT WITH TRACTIONAL RETINAL DETACHMENT. BEFORE THE SURGERY, HIS VISUAL ACUITY HAD REMAINED GOOD UNTIL APPROXIMATELY ONE WEEK AGO, WHEN HE DEVELOPED A RHEGMATOGENOUS COMPONENT. FOUR DAYS AGO THE SUBJECT RECEIVED AN INTRAVITREAL AVASTIN INJECTION TO HELP WITH REGRESSION OF NEOVASCULARIZATION. THE VISUAL ACUITY RAPIDLY DECLINED DRASTICALLY. VITRECTOMY SURGERY WAS PERFORMED TO IMPROVE THE SUBJECT'S VISION. THE PATIENT THEN UNDERWENT THE SURGICAL PROCEDURE. IT WAS REVIEWED THAT DURING THE OPERATION, THERE WAS FOLDING OF THE RETINA, AND THE RETINAL DETACHMENT WAS VERY BULLOUS WITH MULTIPLE AREAS OF RETINAL BREAKS. AN AIR-FLUID EXCHANGE WAS PERFORMED VISUALIZATION WAS LOST DUE TO DUE TO THE DEVELOPMENT OF INSTANTANEOUS CATARACTS WHICH WERE DRAINED. EACH OF THE SCLEROTOMIES HAD LEAKING OF O

  Patient problems: Loss of Vision

  MAUDE report 7386010 ↗
• MalfunctionFeb 20, 2018Device Operational Issue; Device Operational Issue

  A REPORT HAS BEEN RECEIVED OF AN INCIDENT THAT OCCURRED IN IRAN. THE FOLLOWING HAS BEEN REPORTED: "PUMP 160 ERROR." A SAMPLE IS AVAILABLE FOR EVALUATION. THERE IS NO FURTHER INFORMATION AND ALL HAS BEEN DISCLOSED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7284153 ↗