VISIONAIRE V0100080Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556492703), received between Oct 25, 2019 and Oct 25, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Fitting Problem” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryOct 25, 2019Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT DURING SURGERY, THE SURGEON CHANGED THE CUTTING BLOCK FROM VISIONAIRE TO STANDARD ONE FOR CUTTING FURTHER. HOWEVER, THE TWO PINS DIDN'T FIT INTO THE PINHOLES ON THE STANDARD ONE. IT SEEMED THAT THE LENGTH BETWEEN THE TWO PINHOLES ON VISIONAIRE CUTTING BLOCK WERE NOT THE SAME WITH THE STANDARD ONE. NO HARM TO THE PATIENT. 3 MINUTES DELAY. THE DEVICE WILL BE RETURNED FOR EVALUATION. ADDITIONALLY, CASE WAS SENT WITH GII MIS STYLE PINHOLES WHEN JAPAN SHOULD ONLY RECEIVE JOURNEY I STYLE PINHOLES FOR ALL JOURNEY II CASES.

  Patient problems: Injury

  MAUDE report 9241912 ↗