Disposable Eckardt One step Vitrectomy Kit.(23 gauge / 0.6 mm) 1272.E2DISRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08717872002415), received between Oct 12, 2017 and Jul 9, 2018 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 9, 2018Device Contamination with Chemical or Other Material

  THERE IS SOMETHING WHITE ON THE TIP.

  Patient problems: No Information

  MAUDE report 7670627 ↗
• MalfunctionMay 22, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  A FACILITY HAS REPORTED THAT THEY FOUND A GRAY PARTICLE ON A TROCAR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7533018 ↗
• MalfunctionMay 3, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  THE COMPLAINANT INFORMED DUTCH THAT THE CANNULA HAD WHAT LOOKED TO BE A WHITE RESIDUE ON THE BLADE. NO INJURY TO THE PATIENT OCCURED. A PICTURE WAS TAKEN AND WILL BE SENT BY EMAIL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7484895 ↗
• MalfunctionApr 13, 2018Device Operational Issue; Device Operational Issue

  A REPORT FROM (B)(6) HAS BEEN RECEIVED. THE FOLLOWING HAS BEEN REPORTED: A PIECE OF PLASTIC (PROBABLY FROM THE PRODUCTION PROCESS) AT THE TIP OF THE TROCAR. THE CUSTOMER GAVE THE PARTICLE TO HIS MICROBIOLOGY. NO FURTHER INFORMATION. ALL INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7430800 ↗
• InjuryFeb 20, 2018Material Separation; Material Separation

  A REPORT HAS BEEN RECEIVED OF AN EVENT THAT OCCURRED IN (B)(6). IT WAS LEARNED "OUR TECHNICIAN INFORMED US ABOUT THE FOLLOWING COMPLAINT. WHEN MAKING THE INCISION WITH THE TROCAR SYSTEM A PIECE OF METAL DROPPED INTO THE EYE WHEN MAKING THE INCISION WITH THE TROCAR SYSTEM 1272.GE206 OF THE ABOVE MENTIONED SET, A PIECE OF METAL DROPPED INTO THE EYE ON THE RETINA. ACCORDING TO THE SURGEON THE PIECE OF METAL CAME LOOSE FROM THE TROCAR ITSELF. LUCKILY THE SURGEON COULD REMOVE IT FROM THE EYE FAST, SO WE HOPE THAT THERE WAS NO DAMAGE TO THE CUSTOMER. A SAMPLE WILL BE SENT. ALL INFORMATION HAS BEEN DISCLOSED.

  Patient problems: Foreign Body In Patient

  MAUDE report 7283007 ↗
• MalfunctionNov 14, 2017Infusion or Flow Problem; Physical Property Issue; Infusion or Flow Problem; Physical Property Issue

  A REPORT HAS BEEN RECEIVED OF AN INCIDENT THAT OCCURRED IN (B)(6). IT WAS REPORTED THAT THE INFUSION LINE WAS BLOCKED, WHICH CAUSED A HYPOTONY. FURTHERMORE, AFTER REMOVING THE LINE FROM THE EYE, IT WAS FOUND THAT THE METAL WAS BROKEN. AFTER REPLACING THE INFUSION LINE THE SURGEON WAS ABLE TO MAKE A SUFFICIENT SURGERY. THERE WAS NO PATIENT INJURY.

  Patient problems: Intraocular Pressure, Delayed, Uncontrolled

  MAUDE report 7031943 ↗
• MalfunctionOct 12, 2017Physical Property Issue; Physical Property Issue

  THERE IS SOMETHING LIKE WHITE SOLID MATERIAL ON THE TIP PART OF THE TROCAR. COULD YOU PLEASE LET US KNOW WHAT THE WHITE SOLID MATERIAL IS, AND THE REASON WHY THIS WAS ATTACHED? THE SAMPLE IS AVAILABLE FOR EVALUATION. NO REPORT OF ANY HARM TO A PATIENT.

  Patient problems: No Information

  MAUDE report 6946222 ↗