VISIONAIRE V0200110Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556656570), received between Dec 2, 2020 and Dec 2, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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.

• InjuryDec 2, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT, DURING SURGERY, THE VISIONAIRE ADAPTIVE GUIDE DISTAL FEMUR JOURNEY II BLOCK DID NOT FIT CORRECTLY. PROCEDURE CONTINUED WITH A CHANGE IN SURGICAL TECHNIQUE AND WITH A DELAY OF LESS THAN 30 MINUTES. NO ADDITIONAL BONE CUTS WERE PERFORMED AND THE PATIENT WAS NOT HARMED BEYOND THE DESCRIBED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10937129 ↗